[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-complications":35},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,116,0,25,[9,56,90,121,157,193,223,252,285,319,344,375,413,447,479,501,532,562,589,617,650,677,710,733,755],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":4},"100054125","quality-of-life-of-patients-who-have-undergone-bilateral-mastectomy-100054125",false,"NCT07699913","Quality of Life of Patients Who Have Undergone Bilateral Mastectomy","Psychological Experience, Quality of Life, and Patient Satisfaction Following Bilateral Breast Reconstruction After Prophylactic or Therapeutic Mastectomy, Using the BREAST-Q Questionnaire.","RM BREAST Q","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years\n* Bilateral mastectomy\n* Breast reconstruction between January 1, 2015, and January 1, 2026\n* No objection to the study\n\nExclusion Criteria:\n\n* Individual under guardianship or curatorship, or deprived of liberty\n* Reconstruction not completed by January 1, 2026.","FEMALE","18 Years",{"count":21,"type":22},115,"ESTIMATED","OBSERVATIONAL","We therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have undergone bilateral mastectomy. The goal of this observational study is thus to measure and compare the quality of life of patients who have undergone bilateral mastectomy using the BREAST-Q questionnaire.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Surgery Date","Age","BMI","Height","Weight","Smoking Status","Hormone Therapy","Chemotherapy","Radiotherapy","Postoperative Complications","Type of Reconstruction (Flap or Implant)","Timing of Reconstruction","Type of Mastectomy (Prophylactic or Therapeutic)","BRCA Mutation",[41,42,43],"Comparative","observational","retrospective","NOT_YET_RECRUITING","2026-07-07",{"date":47,"type":48},"2026-07-13","ACTUAL",{"date":50,"type":22},"2026-07-10",{"date":52,"type":22},"2026-08-20",{"name":54,"class":55},"University Hospital, Grenoble","OTHER",{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100625855","postoperative-hypocalcemia-after-thyroidectomy-100625855","NCT07428057","Postoperative Hypocalcemia After Thyroidectomy","A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy","Inclusion Criteria:\n\n* Adult patients aged 18 years or older at time of surgery\n* Underwent thyroidectomy at Minia University Hospital\n* Availability of medical records with complete surgical and postoperative data\n* Documented serum calcium levels measured postoperatively\n* Minimum follow-up of 6 months postoperatively or documented outcome status\n\nExclusion Criteria:\n\n* Age less than 18 years at time of surgery\n* Preoperative hypocalcemia (serum calcium \\\u003C8.0 mg\u002FdL or ionized calcium \\\u003C1.0 mmol\u002FL)\n* Pre-existing parathyroid disorders (primary hyperparathyroidism, hypoparathyroidism, secondary or tertiary hyperparathyroidism)\n* Chronic kidney disease Stage 3 or higher (estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73m²)\n* Malabsorption syndromes affecting calcium metabolism (celiac disease, inflammatory bowel disease,short bowel syndrome)\n* Concurrent planned parathyroidectomy\n* History of neck irradiation\n* Chronic use of medications significantly affecting calcium metabolism (bisphosphonates, denosumab,cinacalcet, chronic corticosteroids)\n* Incomplete medical records lacking essential data including surgical details, postoperative calcium levels,or follow-up data\n* Patients lost to follow-up before 6-month endpoint without documented outcome status","ALL","75 Years",{"count":66,"type":22},600,"This retrospective cohort study investigates predictors of postoperative hypocalcemia following thyroidectomy procedures at Minia University Hospital over a 10-year period (2014-2024). Postthyroidectomy hypocalcemia is one of the most common complications of thyroid surgery, affecting 20-50% of patients. The study aims to identify demographic, clinical, laboratory, and surgical factors associated with the development of both transient and permanent hypocalcemia. Results will inform risk stratification, patient counseling, and perioperative management strategies.",[69,70,71,72,35],"Thyroid Nodule","Thyroid Dysfunction","Hypocalcemia","Thyroid Cancer",[74,75,76,77,78],"Thyroidectomy","Postoperative hypocalcemia","Hypoparathyroidism","Parathyroid gland injury","Total thyroidectomy","RECRUITING","2026-06-27",{"date":82,"type":48},"2026-06-30",{"date":84,"type":48},"2026-03-04",{"date":86,"type":22},"2026-08-01",{"name":88,"class":55},"Minia University",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":63,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":89},"100600435","effectiveness-of-hypotension-prediction-index-hpi-in-preventing-hypotension-in-the-post-anesthesia-care-unit-pacu-100600435","NCT07097454","Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU)","Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU): A Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 19 years\n* Undergoing elective surgery under general anesthesia\n* Presence of intra-arterial catheter at the end of surgery\n* Expected PACU stay of ≥ 30 minutes\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Immediate postoperative ICU admission\n* Use of vasopressors during emergence from anesthesia\n* ASA physical status classification of V\n* Known contraindications to arterial line placement\n* Participation in another interventional study within 30 days","19 Years",{"count":99,"type":22},210,"INTERVENTIONAL",[102],"NA","Postoperative hypotension in the post-anesthesia care unit (PACU) is common and linked to adverse outcomes. The Hypotension Prediction Index (HPI) predicts hypotensive events intraoperatively, but its PACU application is unexplored. This study aims to investigate the effectiveness of HPI-guided monitoring in preventing PACU hypotension.",[105,35],"Hypotension",[107,108,109,110,111],"Hypotension Prediction Index (HPI)","PACU","Hemodynamic Monitoring","Arterial Pressure Waveform","HemoSphere","2026-06-24",{"date":114,"type":48},"2026-06-26",{"date":116,"type":22},"2026-07-15",{"date":118,"type":22},"2026-09-11",{"name":120,"class":55},"Wonkwang University Hospital",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":64,"enrollmentInfo":129,"targetDuration":4,"studyType":100,"phases":131,"briefSummary":132,"conditions":133,"keywords":138,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":89},"100641421","preoperative-fasting-and-the-gut-microbiome-before-hip-replacement-100641421","NCT07651462","Preoperative Fasting and the Gut Microbiome Before Hip Replacement","Preoperative Metabolic Optimization: Influence of Intermittent and Buchinger-Type Fasting on the Gut Microbiome, Immune Profile, and Postoperative Complications in Patients Undergoing Primary Total Hip Arthroplasty - A Randomized Controlled Trial","PreFAST-Hip","Inclusion Criteria:\n\n* Adults aged 18-75 years (inclusive)\n* Scheduled for elective primary total hip arthroplasty (THA)\n* Able and willing to provide written informed consent\n* Able to follow the 20-day preoperative fasting protocol independently at home (if randomized to the fasting arm) or willing to be randomized to either arm\n\nExclusion Criteria:\n\n* Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease)\n* Antibiotic therapy within the last 2 months before baseline (T0)\n* Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0)\n* Inability or unwillingness to provide informed consent\n* Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal\u002Fhepatic impairment, eating disorder)\n* BMI \\\u003C 18.5 kg\u002Fm² (underweight)\n* Concurrent participation in another interventional drug or device trial\n* Pregnancy or breastfeeding",{"count":130,"type":22},130,[102],"Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters.\n\nThis single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-\u002FB-\u002FNK-cell subsets, activation\u002Fexhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay).\n\nAdults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h \u002F 24 h \u002F 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.",[134,135,35,136,137],"Hip Osteoarthritis","Arthroplasty, Replacement, Hip","Surgical Wound Infection","Gastrointestinal Microbiome",[139,140,141,142,143,144,145,146,147],"Therapeutic fasting","Buchinger fasting","Intermittent fasting","Gut microbiome","Immunophenotyping","Continuous glucose monitoring","Total hip arthroplasty","Metabolic syndrome","Preoperative optimization","2026-06-17",{"date":150,"type":48},"2026-06-22",{"date":152,"type":48},"2025-07-01",{"date":154,"type":22},"2026-12-31",{"name":156,"class":55},"Charite University, Berlin, Germany",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":165,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":100,"phases":168,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":89},"100644334","timing-of-recruitment-maneuver-in-robotic-prostate-surgery-100644334","NCT07662642","Timing of Recruitment Maneuver in Robotic Prostate Surgery","Comparison of the Effects of Recruitment Maneuver Timing on Postoperative Pulmonary Complications in Patients Undergoing Robotic Prostate Surgery","ROBPROREC1","Inclusion Criteria:\n\n* Patients scheduled for elective robotic prostate surgery\n* Age 18 years or older\n* Body mass index between 18 and 35 kg\u002Fm²\n* No cognitive impairment\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Emergency surgery\n* Preoperative oxygen requirement\n* Cognitive impairment\n* Refusal to participate in the study","MALE",{"count":167,"type":22},86,[102],"Robotic prostate surgery is commonly performed under general anesthesia with carbon dioxide pneumoperitoneum and steep Trendelenburg positioning. These conditions may reduce lung volumes, impair respiratory mechanics, and increase the risk of atelectasis and postoperative pulmonary complications. Recruitment maneuvers combined with individualized positive end-expiratory pressure may improve intraoperative oxygenation and lung compliance; however, the optimal timing of recruitment maneuver application in robotic prostate surgery remains unclear.\n\nThis prospective randomized study aims to compare the effects of recruitment maneuver timing on postoperative pulmonary complications in adult patients undergoing elective robotic prostate surgery. Participants will be randomized into two groups. In the Supine Recruitment Group, the recruitment maneuver will be performed before carbon dioxide insufflation while the patient is in the supine position, followed by individualized PEEP determination. In the Trendelenburg Recruitment Group, the recruitment maneuver will be performed after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination. Patients will be evaluated for postoperative pulmonary complications up to postoperative 72 hours or until discharge, whichever occurs first.",[171,172,173,174,35],"Robotic Surgery","Urologic Surgical Procedures","Postoperative Pulmonary Complications (PPCs)","Pulmonary Atelectasis",[176,177,178,179,180,181,182,183],"Robotic prostate surgery","Recruitment maneuver","Pneumoperitoneum","Trendelenburg position","Positive end-expiratory pressure","Atelectasis","Postoperative pulmonary complications","General anesthesia","2026-06-16",{"date":186,"type":48},"2026-06-23",{"date":188,"type":48},"2026-05-09",{"date":190,"type":22},"2026-07-20",{"name":192,"class":55},"Ankara University",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":100,"phases":202,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":89},"100641148","non-thermal-plasma-to-reduce-recurrence-in-chronic-subdural-hematoma-100641148","NCT07656818","Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma","Application of Non-Thermal Plasma in the Surgical Bed of Chronic Subdural Hematoma to Reduce the Post-Drainage Recurrence Rate: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy)\n* Ability to provide written informed consent (or consent from legal representative if patient is incapacitated)\n\nExclusion Criteria:\n\n* Pure acute or subacute subdural hematoma\n* Uncontrolled coagulopathy or bleeding disorder\n* History of intracranial aneurysm or prior cerebrovascular event with residual deficit\n* Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region\n* Pregnancy or lactation\n* Participation in another interventional clinical trial within 30 days prior to screening",{"count":201,"type":22},40,[102],"The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are:\n\n* Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone?\n* Is NTP safe when applied to the subdural space and surgical wound bed?\n* Does NTP improve functional outcomes and time to hematoma resolution?\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision.\n* Control group (n = 20): Standard surgical drainage alone (no NTP).\n\nFollow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).",[205,206,207,35],"Chronic Subdural Hematoma","Subdural Hematoma","Recurrence",[209,210,211,212,213,214],"Non-thermal plasma","Cold plasma","Chronic subdural hematoma","Neurosurgery","Recurrence prevention","Wound healing",{"date":216,"type":48},"2026-06-18",{"date":218,"type":48},"2026-03-02",{"date":220,"type":22},"2027-04-30",{"name":222,"class":55},"Benjamín Gonzalo Rodríguez Méndez",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":100,"phases":233,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":89},"100633236","the-application-of-infrared-thermography-in-the-prediction-of-skin-healing-in-surgery-100633236","NCT07524062","The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery","The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery THERMS: THermography for Evaluation of Recovery and Monitoring of Surgical Wounds","THERMS","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Adult subjects (\\>18 years of age) at time of enrolment\n3. Patients undergoing a surgical excision under local anesthesia\n4. Indications of the excisions were skin lesions suspected to be malignant, skin lesions confirmed to be malignant via prior biopsy\n\nExclusion Criteria:\n\n1. Patient has history of pre-existing diabetes type I and II\n2. Patients with pre-existing chronic wound problems\n3. Patients with renal dysfunction,\n4. Patients with venous insufficiency confirmed via radiographic imaging\n5. Patients who received radiotherapy in the affected area in the past\n6. Patients with chronic steroid use in the past (\\> 3 months) or a immunosuppressant medication history\n7. Female who is pregnant",{"count":232,"type":22},120,[102],"This study investigates whether infrared thermography, a harmless and non-invasive thermal camera technique, can help monitor how surgical wounds heal after skin surgery. The goal is to detect wound problems earlier, such as infection or delayed healing, and to support doctors in making timely clinical decisions.",[236,136,35,237,238],"Wound Healing","Skin Neoplasms","Skin Transplantation",[240,241,242,243,244],"Infrared thermography","Surgical wound healing","Dermatosurgery","Thermal imaging","Wound complications",{"date":216,"type":48},{"date":247,"type":48},"2026-06-15",{"date":249,"type":22},"2028-10",{"name":251,"class":55},"Universitaire Ziekenhuizen KU Leuven",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":100,"phases":262,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100617070","comparison-of-self-locking-versus-traditional-sutures-in-double-layer-laparoscopic-vaginal-vault-closure-after-hysterectomy-bi-sure-trial-100617070","NCT07313839","Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)","Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial","BI-SURE","Inclusion Criteria:\n\n* Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease\n* Age ≥ 18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Laparotomic or vaginal hysterectomy\n* Contraindication to laparoscopic vaginal vault closure",{"count":261,"type":22},310,[102],"Vaginal vault closure after laparoscopic or robotic hysterectomy may be associated with postoperative complications such as vaginal cuff dehiscence, infection, and bleeding. The optimal suture material and technique for laparoscopic colporrhaphy, particularly in patients undergoing surgery for gynecologic malignancies, remain controversial.\n\nThe BI-SURE trial is a multicenter, randomized controlled study designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure after hysterectomy. The study aims to evaluate postoperative effectiveness and safety within three months after surgery.",[265,266,35],"Gynecologic Cancers","Vaginal Cuff Dehiscence",[268,269,270,271,272,273,274,275,276],"Laparoscopic hysterectomy","Vaginal vault closure","Colporrhaphy","Self-locking suture","Barbed suture","Polyglactin 910","Gynecologic oncology","Postoperative complications","Randomized controlled trial",{"date":148,"type":48},{"date":279,"type":48},"2025-10-07",{"date":281,"type":22},"2027-01",{"name":283,"class":55},"Azienda Ospedaliero-Universitaria di Parma",5,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":63,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":296,"conditions":297,"keywords":304,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100642485","perioperative-respiratory-adverse-events-in-cleft-lip-and-palate-surgery-incidence-risk-factors-and-clinical-scoring-100642485","NCT07651904","Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring","Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores","Inclusion Criteria:\n\n* Age 0-3 years (infants and toddlers)\n* Scheduled for elective cleft lip and\u002For palate repair surgery\n* General anesthesia planned\n* Written parental\u002Fguardian informed consent obtained\n\nExclusion Criteria:\n\n* Pre-existing respiratory failure or active tracheostomy\n* Emergency surgical procedures\n* Inability to obtain parental\u002Fguardian consent","0 Years","3 Years",{"count":295,"type":22},150,"Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.\n\nThis prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and\u002For palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.",[298,299,300,301,302,35,303],"Cleft Palate","Cleft Lip","Laryngospasm","Bronchospasm","Airway Obstruction","Difficult Intubation",[305,306,307,308,309,310,311],"cleft lip","cleft palate","pediatric anesthesia","perioperative respiratory adverse events","Han mask ventilation score","micrognathia","intubation difficulty score","2026-06-13",{"date":184,"type":48},{"date":80,"type":22},{"date":316,"type":22},"2027-12-30",{"name":318,"class":55},"Marmara University Pendik Training and Research Hospital",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":89},"100642751","wearable-device-based-early-warning-of-postoperative-complications-in-thoracic-surgery-100642751","NCT07646730","Wearable Device-Based Early Warning of Postoperative Complications in Thoracic Surgery","Development and Validation of a Wearable Device-Based Early Warning Model for Postoperative Complications in Thoracic Surgery: A Retrospective and Prospective Cohort Study","wearable","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Hospitalized in the Department of Thoracic Surgery of Tongji Hospital and scheduled to undergo thoracic surgery.\n3. Able to wear the study-designated wearable device after hospital admission and expected to continue wearing the device and\u002For uploading data within 30 days after discharge.\n\nExclusion Criteria:\n\n1. Patients or family members are unwilling to wear the wearable device or unable to meet the required wearing time.\n2. Severe or unstable psychiatric disease, such as severe depression or schizophrenia.\n3. Pregnancy or lactation.\n4. Allergy to the watch strap material or local skin conditions that prevent wearing the device.\n5. Unable to complete follow-up within 30 days after discharge.",{"count":328,"type":22},650,"After thoracic surgery, some patients may develop complications such as lung infection, abnormal heart rhythm, fluid around the lung, prolonged air leak, wound infection, emergency department visits, or hospital readmission. These problems may not be found early if monitoring is only done during routine vital sign checks or follow-up visits.\n\nThis study will evaluate whether data collected by a wearable device can help identify early warning signs of postoperative complications in patients undergoing thoracic surgery. The wearable device will collect information such as heart rate, oxygen level, skin temperature, physical activity, sleep, and wearing status.\n\nThe study includes two parts. First, the researchers will review previously collected wearable device and medical record data to develop an early warning model. Second, new patients undergoing thoracic surgery will wear the device from hospital admission until about 30 days after discharge. The model will then be tested to see how well it predicts complications that require medical intervention within 30 days after surgery.\n\nThe main goal is to evaluate how accurately the wearable device-based model can identify patients who develop postoperative complications and how early the model can provide a warning before the complication is clinically confirmed.",[35,331,332],"Thoracic Surgery","Perioperative Monitoring",[334,335,35,331],"Wearable Device","Early Warning Model","2026-06-12",{"date":247,"type":48},{"date":339,"type":48},"2025-12-16",{"date":341,"type":22},"2026-12-15",{"name":343,"class":55},"Tongji Hospital",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":354,"conditions":355,"keywords":359,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100618701","prediction-model-for-mins-after-major-hepatobiliary-surgery-100618701","NCT07335042","Prediction Model for MINS After Major Hepatobiliary Surgery","Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery","Inclusion Criteria:\n\nAdults (18-85 yr, ASA physical status II-III) undergoing major hepatobiliary surgery were enrolled. Major surgery was defined as duration ≥ 3 h involving hepatectomy (≥ 3 segments) or biliary reconstruction necessitating ICU admission. Eligibility required paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data and comprehensive documentation of surgical covariates, including surgical approach (laparoscopic vs. open), resection nature (anatomic vs. non-anatomic), number of resected segments, tumor characteristics (size and location), and presence of cirrhosis.\n\nExclusion Criteria:\n\n(1) preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate \\\u003C 60 ml\u002F (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.","85 Years",{"count":353,"type":22},1800,"This multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. The study adopts a nested modeling strategy, starting with baseline risk factors (e.g., RCRI) and stepwise incorporating hepatic inflow occlusion strategies (specifically comparing SPVO vs. Pringle maneuver) and routine intraoperative biomarkers. The model's performance will be evaluated using AUC, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), followed by interpretability analysis using SHAP values and external validation in an independent cohort.",[356,35,357,358],"Myocardial Injury After Noncardiac Surgery (MINS)","Liver Neoplasm","Hepatobiliary Diseases",[360,361,362,363,364,365,366],"MINS","Major Hepatobiliary Surgery","Hepatectomy","Hepatic Inflow Occlusion","Pringle Maneuver","Prediction Model","High-sensitivity Cardiac Troponin",{"date":247,"type":48},{"date":369,"type":48},"2026-01-14",{"date":371,"type":22},"2027-06-30",{"name":373,"class":55},"Beijing Tsinghua Chang Gung Hospital",6,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":100,"phases":385,"briefSummary":386,"conditions":387,"keywords":398,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":412},"100619934","post-market-study-of-the-signia-circular-stapler-with-tri-staple-technology-in-left-sided-colon-sigmoid-and-rectal-resections-100619934","NCT07351071","Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections","A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)","SECURE","Preoperative Inclusion Criteria:\n\n1. Subject is competent and willing to provide documented informed consent to participate in this clinical study\n2. Subject is intended to undergo an elective left sided colon\u002Fcolorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler\n3. Subject is ≥ 18 years of age at time of consent\n\nPreoperative Exclusion Criteria:\n\n1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule\n2. Subject with ASA classification ≥ IV\n3. Subject is pregnant (as determined by standard site practices)\n4. The procedure is an emergency procedure\n5. The procedure is a revision\u002Freoperation for the same indication\n6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months\n7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study\n8. Subject will undergo multiple synchronous colon resections\n9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)\n10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure\n11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)\n12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)\n13. Any subject undergoing an ileal-anal pouch anastomosis surgery\n\nIntraoperative Exclusion Criteria\n\n1. Anastomosis not attempted with the Signia™ circular stapler\n2. Any subject for which the device is intended to be used outside the instructions for use (IFU)",{"count":384,"type":22},137,[102],"The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.",[388,389,390,391,392,393,394,395,396,35,397],"Colorectal Anastomosis","Left-sided Colon Resection","Anastomotic Leak","Anastomotic Complication","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Anastomotic Leaks",[388,389,399,390,400,401,402],"Circular stapler","Rectal cancer","Low anterior resection","Powered stapler","2026-06-11",{"date":336,"type":48},{"date":406,"type":48},"2025-12-30",{"date":408,"type":22},"2027-02-28",{"name":410,"class":411},"Medtronic - MITG","INDUSTRY",9,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":423,"conditions":424,"keywords":430,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":4},"100642479","ventilation-modalities-during-transport-of-postoperative-critically-ill-patients-to-the-icu-100642479","NCT07646249","VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU","VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU - A Multicenter Observational Study","VENTICRIT","Inclusion criteria\n\n* Intubated patients undergoing general anesthesia for non-cardiac surgery\n* Requirement for postoperative IMV\n* Age ≥18 years\n* Obtained informed consent Exclusion criteria\n* Patients undergoing cardiac surgery\n* Patients receiving preoperative mechanical ventilation prior to surgery.",{"count":422,"type":22},800,"Patients undergoing major non-cardiac surgery may require postoperative mechanical ventilation and transfer from the operating room to the intensive care unit (ICU). This intra-hospital transport phase is critical, as patients may experience changes in respiratory and hemodynamic status, including alterations in oxygenation, ventilation, blood pressure, and heart rate.\n\nDuring transport, ventilatory support may be provided using different strategies, including manual ventilation with a bag-valve device or mechanical ventilation with a portable ventilator. Although both approaches are commonly used in clinical practice, there is limited evidence comparing their effects on respiratory function, gas exchange, and overall physiological stability during and after transport.\n\nThis multicenter, prospective observational study aims to describe current clinical practices in ventilatory support during intra-hospital transport in adult patients undergoing non-cardiac surgery who require ICU admission. The study will also evaluate changes in vital signs, arterial blood gas parameters, and respiratory mechanics, as well as the occurrence of adverse events during transport and postoperative pulmonary complications within the first five days after surgery.\n\nNo additional interventions or procedures beyond standard clinical care will be performed. All data will be collected as part of routine clinical practice. The results of this study are expected to improve the understanding of ventilation management during transport and to identify safer and more effective strategies for critically ill postoperative patients.",[425,426,427,35,428,429],"Respiration, Artificial","Positive-Pressure Respiration","Postoperative Complications (Cardiopulmonary)","Critical Illness","Intensive Care Units",[431,432,433,425,426,434,35,435,428,429,436,437,438],"Intra-hospital Transport","Mechanical Ventilation","Manual Ventilation","Postoperative Care","Postoperative Pulmonary Complications","Endotracheal Intubation","General Anesthesia","Non-Cardiac Surgery","2026-06-09",{"date":336,"type":48},{"date":442,"type":22},"2026-07-01",{"date":444,"type":22},"2027-10-01",{"name":446,"class":55},"Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":100,"phases":457,"briefSummary":458,"conditions":459,"keywords":468,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":89},"100596071","negative-pressure-wound-therapy-for-split-thickness-skin-grafting-to-the-lower-leg-after-excision-of-skin-tumour-a-multicentre-randomised-study-100596071","NCT07040683","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: The Legs Trial - A Multicentre Randomised Study","LEGS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)\n* Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery\n* Ability to provide written informed consent\n* Ability to comply with postoperative instructions and follow-up visits\n\nExclusion Criteria:\n\n* Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers\n* Inability to provide informed consent\n* Severe systemic illness, including:\n* Ongoing sepsis\n* Advanced heart failure\n* End-stage renal or liver disease\n* Active chemotherapy within the previous three months\n* Ongoing treatment with immunosuppressive medications, including:\n* Systemic corticosteroids (e.g., prednisone \\>20 mg\u002Fday or equivalent)\n* Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)\n* Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil)\n* mTOR inhibitors (e.g., sirolimus, everolimus)\n* Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors)\n* Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib)\n* Other immunosuppressive drugs\n* Previous radiation therapy to the surgical site\n* Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)",{"count":456,"type":22},242,[102],"The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are:\n\nDoes NPWT reduce the incidence of transplant infection within three months after STSG?\n\nDoes NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use?\n\nResearchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes.\n\nParticipants will:\n\nUndergo excision of a skin tumour on the lower leg followed by STSG.\n\nBe randomized to receive either NPWT or traditional dressings applied over the graft.\n\nFollow a structured postoperative care and mobilisation schedule.\n\nAttend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.",[238,460,461,462,35,136,463,464,465,236,466,467],"Skin Grafting","Split Thickness Skin Graft","Negative-Pressure Wound Therapy","Lower Extremity","Skin Cancer","Skin Tumour","Bandages","Leg",[238,460,469,462,35,136,463,236,466,467,237,464],"Split Thickness","2026-05-27",{"date":472,"type":48},"2026-05-28",{"date":474,"type":48},"2025-11-01",{"date":476,"type":22},"2030-03-31",{"name":478,"class":55},"Region Skane",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":89},"100538856","mechanical-ventilation-in-surgical-patients-100538856","NCT06296277","Mechanical Ventilation in Surgical Patients","Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry","MEET VENUS","Inclusion Criteria:\n\n* Adults; and\n* Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery\n\nExclusion Criteria:\n\n* Receiving intraoperative IMV outside of an operating room; and\n* Receiving intraoperative IMV during extracorporeal life support",{"count":488,"type":22},10000,"This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.\n\nPatients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded",[491,492,35],"Surgery","Ventilator Lung","2026-05-25",{"date":472,"type":48},{"date":496,"type":48},"2026-03-01",{"date":498,"type":22},"2027-08-31",{"name":500,"class":55},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":100,"phases":511,"briefSummary":512,"conditions":513,"keywords":517,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":529,"locationsCount":89},"100640072","optimal-peep-for-postoperative-oxygenation-and-lung-aeration-ultrasvent-2-100640072","NCT07613177","Optimal PEEP for Postoperative Oxygenation and Lung Aeration (ULTRASVENT-2)","Effect of Positive End-Expiratory Pressure (PEEP) Level on Postoperative Oxygenation and Lung Aeration Assessed by Lung Ultrasound Monitoring: A Multicenter Randomized Controlled Trial (ULTRASVENT-2)","ULTRASVENT-2","Inclusion Criteria:\n\n* Age greater than or equal to 18 years.\n* Planned elective non-cardiac and non-thoracic surgical intervention requiring general anesthesia with mechanical ventilation.\n* Airway protection utilizing an endotracheal tube.\n* Assignment to one of the four specific surgical strata: non-abdominal, major open abdominal, major laparoscopic abdominal, or low-trauma laparoscopic surgery.\n* Baseline lung ultrasound showing no pathological findings, corresponding to a total preoperative LUS score of 0.\n* Technical feasibility of performing a postoperative lung ultrasound within the first 2 hours after the completion of surgery.\n* Signed written informed consent to participate in the clinical trial.\n\nExclusion Criteria:\n\n* Planned cardiac or thoracic surgery (e.g., coronary artery bypass grafting, valve replacement, heart transplantation, lung resection, esophageal surgery).\n* Pneumothorax diagnosed before or during the surgical procedure.\n* Inability to adequately visualize the target dorsal-basal lung zones by ultrasound due to physical limitations (e.g., morbid obesity, massive surgical dressings, anatomical anomalies, or dermatological lesions in the scanning area).\n* Presence of hydrothorax detected on the baseline preoperative ultrasound.\n* Confirmed perioperative aspiration of gastric contents or other foreign material.\n* Any pathological changes identified during the baseline ultrasound of the dorsal-basal lung regions (a total preoperative LUS score greater than 0).\n* Requirement for massive blood transfusion during the surgery, defined according to local institutional criteria.\n* Surgical interventions directly involving or violating the diaphragm.\n* Expected inability to conduct reliable postoperative clinical and ultrasound assessments (e.g., need for deep sedation preventing wakefulness and contact, or planned transfer to another facility).",{"count":510,"type":22},360,[102],"The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2\u002FFiO2 (S\u002FF ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation.\n\nPatients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.",[35,514,174,515,516],"Respiratory Insufficiency","Positive-End Expiratory Pressure","Hypoxemia",[518,519,520,521,522],"Lung ultrasound","S\u002FF ratio","Perioperative lung protection","Laparoscopic surgery","Open laparotomy","2026-05-23",{"date":525,"type":48},"2026-05-29",{"date":442,"type":22},{"date":528,"type":22},"2026-12-20",{"name":530,"class":531},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":63,"minAge":4,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":100,"phases":541,"briefSummary":542,"conditions":543,"keywords":548,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":89},"100638252","preoperative-immunonutrition-in-patients-with-bone-and-soft-tissue-sarcomas-100638252","NCT07609329","Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas","Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n* Adult patients aged 18 years or older.\n* Histologically confirmed bone sarcoma or soft tissue sarcoma.\n* Localized or oligometastatic disease.\n* Indicated for planned orthopedic tumor resection.\n* Preoperative interval allowing administration of the nutritional intervention for at least 7 days, with 14 days preferred when clinically feasible.\n* Ability to receive oral nutritional supplementation.\n* Signed informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Participants will be excluded if any of the following criteria are present:\n* Indication for urgent surgery.\n* Disseminated disease with more than five metastases.\n* Ongoing parenteral nutrition before study enrollment.\n* Inability to receive oral intake.\n* Severe hepatic failure.\n* Severe renal failure.",{"count":540,"type":22},100,[102],"This study will evaluate whether a short nutritional intervention before surgery can improve recovery in patients with bone and soft tissue sarcomas.\n\nPatients with these tumors often have a higher risk of poor nutrition and loss of muscle mass. These problems may increase the risk of complications after major orthopedic surgery.\n\nParticipants will be randomly assigned to one of two groups. One group will receive a special oral nutritional supplement twice daily before surgery, in addition to standard care. The other group will receive standard care without the preoperative nutritional supplement.\n\nThe main aim of the study is to compare the rate of clinically relevant postoperative complications within 30 days after surgery. The study will also evaluate changes in muscle mass on CT scans, blood markers of nutrition and inflammation, nutritional risk, functional status, length of hospital stay, and tolerance of the nutritional supplement.",[544,545,546,547,35],"Bone Sarcoma","Soft Tissue Sarcoma","Sarcopenia","Malnutrition",[549,550,551,547,552,553,546],"Sarcoma","Bone sarcoma","Soft tissue sarcoma","Preoperative Nutrition","Immunonutrition","2026-05-19",{"date":470,"type":48},{"date":557,"type":48},"2026-04-01",{"date":559,"type":22},"2028-12-31",{"name":561,"class":55},"St. Anne's University Hospital Brno, Czech Republic",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":571,"conditions":572,"keywords":576,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":587,"locationsCount":89},"100640251","trajectory-based-phenotyping-after-coronary-artery-bypass-surgery-100640251","NCT07598682","Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery","Early Postoperative Trajectory-Based Phenotyping Improves Risk Stratification Beyond EuroSCORE in Patients Undergoing Coronary Artery Bypass Grafting","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients who underwent elective on-pump coronary artery bypass grafting\n* Patients operated between January 1, 2022 and December 31, 2025\n* Patients with available perioperative clinical and laboratory data required for analysis\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n* Patients undergoing concomitant valve surgery\n* Patients with missing or inconsistent key clinical or laboratory data",{"count":570,"type":22},1000,"Coronary artery bypass grafting is a commonly performed heart surgery, but patients may have different risks for postoperative complications even when their preoperative risk scores are similar. EuroSCORE II is widely used to estimate surgical risk before cardiac surgery, but it may not fully reflect how the body responds during the early postoperative period.\n\nThis retrospective observational study will evaluate adult patients who underwent elective coronary artery bypass grafting with cardiopulmonary bypass between January 1, 2022 and December 31, 2025. The study will use existing hospital records and laboratory data. No additional treatment, test, or intervention will be given to patients as part of this study.\n\nThe main aim is to examine whether early postoperative changes in inflammatory and renal laboratory markers can identify different patient subgroups, called phenotypes. These markers include neutrophil-to-lymphocyte ratio, systemic immune-inflammation index, triglyceride-glucose index, and serum creatinine. The study will evaluate whether these phenotype groups are associated with postoperative acute kidney injury and prolonged intensive care unit stay.\n\nThe study will also assess whether this early postoperative phenotype-based classification provides additional risk information beyond EuroSCORE II.",[573,574,35,575],"Coronary Artery Bypass Grafting","Postoperative Acute Kidney Injury","Risk Stratification",[577,578,579,580],"Coronary artery bypass grafting","Postoperative phenotyping","EuroSCORE II","Risk stratification","2026-05-13",{"date":583,"type":48},"2026-05-20",{"date":585,"type":22},"2026-05-07",{"date":442,"type":22},{"name":588,"class":531},"Bursa Sevket Yilmaz Training and Research Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":100,"phases":597,"briefSummary":598,"conditions":599,"keywords":603,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":89},"100561776","free-fluid-detection-with-telementored-efast-100561776","NCT06594562","Free Fluid Detection With Telementored eFAST","Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid","Inclusion Criteria:\n\nPatients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery\n\nExclusion Criteria:\n\nAllergy to ultrasound gel. Patients colonized with ESBL, MRSA and VRE will be excluded due to infection control. Significant postoperative pain that can exacerbated by probe pressure.",{"count":201,"type":22},[102],"This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.",[600,601,602,35],"Hemoperitoneum","Ascites","Intra-Abdominal Fluid Collection",[604,605,606,607],"Teleultrasound","eFAST","Telemedicine","Ultrasound","2026-05-12",{"date":610,"type":48},"2026-05-15",{"date":612,"type":48},"2025-06-18",{"date":614,"type":22},"2026-10-01",{"name":616,"class":55},"Oslo University Hospital",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":100,"phases":626,"briefSummary":627,"conditions":628,"keywords":633,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":649},"100638709","prehabilitation-before-major-surgery-100638709","NCT07590141","Prehabilitation Before Major Surgery","PRehabilitation In Advance of Major Elective Surgery: A Pilot Randomized Controlled Trial (PRIME Pilot)","PRIME","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Undergoing major elective intra-thoracic, intra-abdominal or orthopedic surgery. Major surgery is defined as any operation performed under general and\u002For spinal anesthesia requiring a skin incision extending beyond the subcutaneous tissue\n* More than 3 weeks from the date of scheduled operation\n\nExclusion Criteria:\n\n* Emergency Surgery\n* Operation in less than 3 weeks from time of initial research contact\n* Patients who are pregnant\n* Unable\u002Funwilling to sign written informed consent\n* Physical, cognitive or psychological impairment\n* Unable to understand\u002Fcommunication in English.",{"count":232,"type":22},[102],"The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for adults undergoing major elective surgery. The main questions it aims to answer are:\n\n1. Can researchers successfully recruit and retain participants across multiple sites?\n2. Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?\n\nResearchers will compare the prehabilitation program to standard preoperative care to see if the intervention is feasible to implement and whether it may help reduce postoperative complications.\n\nParticipants will:\n\n* Be randomly assigned to receive either the prehabilitation program or usual care\n* Complete questionnaires and physical assessments before and after the intervention\n* (For those in the intervention group) Receive exercise, nutrition, and mindfulness guidance, protein supplements, and use the CloudDX virtual care platform to support their activities",[629,630,631,35,632],"Prehabilitation","Preoperative Care","Elective Surgical Procedures","Surgical Procedures, Operative",[634,635,636,637,638,639,640],"Home-based Care","Virtual Care","Remote Health Monitoring","Exercise Therapy","Nutritional Support","Psychological Support","Postoperative Outcomes","2026-05-10",{"date":610,"type":48},{"date":644,"type":22},"2026-06-01",{"date":646,"type":22},"2028-01-31",{"name":648,"class":55},"Queen's University",3,{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":100,"phases":658,"briefSummary":660,"conditions":661,"keywords":664,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":89},"100561262","phase-4-the-effect-of-different-types-of-mouthwash-on-extraction-sockets-healing-100561262","NCT06587880","The Effect of Different Types of Mouthwash on Extraction Sockets' Healing","A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets","Inclusion Criteria:\n\n* Male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar that is indicated for extraction with bone removal and the presence of an adjacent second molar.\n\nExclusion Criteria:\n\n* Soft tissue impaction that will not need any bone removal.\n* Presence of any acute oral infection including active Pericoronitis.\n* Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment.\n* Patients receiving medications known to induce gingival hyperplasia; anticonvulsant (phenytoin), immunosuppressant (cyclosporine A), and various calcium channel blockers (nifedipine, verapamil, diltiazem).\n* Patients who have taken systemic antibiotics less than 3 months prior to baseline.\n* Presence of uncontrolled diabetes, severe nutritional deficiencies and endocrine disturbances.\n* Presence of immune deficiency or any immune disease.\n* Intravenous bisphosphonates or Oral bisphosphonate intake for more than 3 years.\n* Smokers and alcoholics.\n* Pregnant or lactating females.\n* Hypersensitivity to one of the ingredients listed in any of the mouthwashes, especially chlorhexidine as reactions to this has been reported in the literature.",{"count":540,"type":22},[659],"PHASE4","The goal of this clinical trial is to assess the effect of four different types of mouthwash on socket healing after surgical extractions in male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar indicated for extraction. The main questions it aims to answer are:\n\nThe effect of Bone Bioactive Liquid (BBL) mouthwash, Hyaluronic Acid (HA) mouthwash, the Chlorhexidine digluconate (CHX) mouthwash and Warm Saline Mouth Rinse (WSMR) on socket healing after surgical extractions.\n\nThe effect of BBL mouthwash, HA mouthwash, the CHX mouthwash and WSMR on patient related factors and their quality of life.\n\nRecruited Participants will be randomized into four intervention groups:\n\n1. First group will receive BBL mouthwash.\n2. The second group will receive CHX mouthwash.\n3. The third group will be prescribed HA mouthwash.\n4. The fourth group will receive Warm Saline Mouth Rinse.",[662,663,35],"Extraction Socket Healing","Quality of Life",[665,666,667,275,668],"Clinical trial","Mouthwash","Socket healing","Quality of life","2026-05-03",{"date":585,"type":48},{"date":672,"type":48},"2025-08-10",{"date":674,"type":22},"2026-12",{"name":676,"class":55},"University of Jordan",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":685,"enrollmentInfo":686,"targetDuration":4,"studyType":100,"phases":687,"briefSummary":688,"conditions":689,"keywords":694,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":89},"100527265","promoting-sleep-to-alleviate-pain---arthroplasty-100527265","NCT06145516","Promoting Sleep to Alleviate Pain - Arthroplasty","Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial","PROSAP-A","Inclusion Criteria:\n\n* age ≥18 years\n* insomnia severity index score \\>10\n* fulfill DSM-V criteria for persistent insomnia disorder\n* average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and\u002For movement-related pain NRS score ≥4 after 5 minutes walking\n* scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis\n\nExclusion Criteria:\n\n* uncontrolled medical disorders\n* nightshift work\n* ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence\n* current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus\n* severely impaired vision (precluding ability to take part of study interventions)","100 Years",{"count":540,"type":22},[102],"PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.",[690,691,692,491,693,35],"Osteoarthritis, Knee","Osteoarthritis, Hip","Insomnia","Pain, Postoperative",[695,696,697,698,699,700],"osteoarthritis","total knee arthroplasty","total hip arthroplasty","insomnia","sleep disturbance","postoperative pain","2026-04-29",{"date":703,"type":48},"2026-05-06",{"date":705,"type":48},"2025-09-01",{"date":707,"type":22},"2030-12-01",{"name":709,"class":55},"Uppsala University",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":720,"conditions":721,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":723,"lastUpdatePostDateStruct":724,"startDateStruct":726,"completionDateStruct":728,"leadSponsor":730,"locationsCount":732},"100454552","biomarkers-in-perioperative-management-100454552","NCT05199025","Biomarkers in Perioperative Management","Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery","BIGPROMISE","Inclusion Criteria:\n\n* Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery)\n* Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).\n* Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)\n* Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* Emergent surgery\n* No informed consent",{"count":719,"type":22},5000,"Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions.\n\nObjective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers.\n\nStudy design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery.\n\nIntervention (if applicable): Not applicable. Main study parameters\u002Fendpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.",[35,663,722],"Death","2026-04-22",{"date":725,"type":48},"2026-04-27",{"date":727,"type":48},"2021-10-12",{"date":729,"type":22},"2026-12-01",{"name":731,"class":55},"St. Antonius Hospital",2,{"id":734,"slug":735,"hasResults":12,"nctId":736,"briefTitle":737,"officialTitle":738,"acronym":4,"eligibilityCriteria":739,"healthyVolunteers":12,"sex":63,"minAge":19,"maxAge":4,"enrollmentInfo":740,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":742,"conditions":743,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":89},"100634687","prediction-of-postoperative-icu-requirement-in-oncologic-surgery-100634687","NCT07542925","Prediction of Postoperative ICU Requirement in Oncologic Surgery","Comparison of ASA, SORT, CACI, and P-POSSUM Scores for Predicting Postoperative Intensive Care Unit Requirement in Patients Undergoing Oncologic Surgery","Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* Patients scheduled for elective or emergency oncologic surgery.\n* Patients who are able to provide written informed consent.\n* Patients whose data will be analyzed for both planned and unplanned intensive care unit (ICU) admissions.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients requiring continuous ICU follow-up due to a pre-existing critical illness prior to the current surgery.\n* Patients who do not provide consent to participate in the study.",{"count":741,"type":22},500,"This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Accurate prediction of postoperative ICU admission is essential for optimizing patient safety and efficient allocation of limited critical care resources, particularly in high-risk oncologic surgical populations.\n\nA total of 500 adult patients scheduled for elective or emergency oncologic surgery will be prospectively enrolled at a single tertiary oncology center. Preoperative clinical and demographic data, intraoperative variables, and perioperative characteristics will be recorded using a standardized data collection form. Risk assessment will include the American Society of Anesthesiologists (ASA) Physical Status classification, Surgical Outcome Risk Tool (SORT), Age-adjusted Charlson Comorbidity Index (CACI), Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels.\n\nThe primary outcome is the need for postoperative ICU admission within the first 24 hours after surgery. Secondary outcomes include unplanned ICU admission, duration of ICU stay, need for mechanical ventilation, hospital length of stay, and 30-day mortality. The predictive performance of each scoring system will be evaluated using receiver operating characteristic (ROC) analysis and multivariable logistic regression models.",[744,35,745,429],"Neoplasms","Perioperative\u002FPostoperative Complications","2026-04-18",{"date":748,"type":48},"2026-04-21",{"date":750,"type":48},"2025-12-15",{"date":752,"type":22},"2026-11-15",{"name":754,"class":55},"Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital",{"id":756,"slug":757,"hasResults":12,"nctId":758,"briefTitle":759,"officialTitle":759,"acronym":4,"eligibilityCriteria":760,"healthyVolunteers":12,"sex":63,"minAge":761,"maxAge":19,"enrollmentInfo":762,"targetDuration":4,"studyType":100,"phases":764,"briefSummary":765,"conditions":766,"keywords":776,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":792,"lastUpdatePostDateStruct":793,"startDateStruct":795,"completionDateStruct":797,"leadSponsor":799,"locationsCount":89},"100635064","phase-4-efficacy-and-cost-effectiveness-of-topical-vancomycin-powder-in-preventing-pediatric-ventriculoperitoneal-shunt-infections-across-different-etiologies-100635064","NCT07547826","Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n* Age Range: Paediatric patients from birth (neonates) up to 18 years of age.\n* Indication: Patients undergoing primary (first-time) Ventriculoperitoneal (VP) shunt insertion.\n* Aetiology: Hydrocephalus due to congenital causes, post-haemorrhagic, or post-inflammatory origins.\n* Consent: Written informed consent provided by the parents or legal guardians.\n\nExclusion Criteria:\n\nTo ensure that the infection rate is strictly related to the surgical procedure and not to external chronic factors, patients with the following will be excluded:\n\n* Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induced immunosuppression, or potential radiotherapy on wound integrity.\n* Co-morbidities: Patients with Diabetes Mellitus, chronic renal failure, or known immunodeficiency disorders (to isolate paediatric physiological response).\n* Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.\n* Hypersensitivity: Known history of allergy to Vancomycin.\n* Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months.\n* Local Skin Issues: Active dermatitis or infection at any of the planned incision sites.\n* Complex Hydrocephalus: Patients requiring additional concurrent neurosurgical procedures (e.g., tumor biopsy, Chiari decompression, or cyst fenestration) to avoid prolonged operative time as a confounding risk factor for infection.\"","1 Day",{"count":763,"type":22},164,[659],"Objectives\n\n* Primary:\n* To measure the reduction in VP shunt infection rates using topical vancomycin powder.\n* Secondary:\n* To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).\n* To analyze the microbiological profile of failed cases.\n* To compare the \"Time-to-Infection\" and shunt survival rates between the study and control groups using Kaplan-Meier analysis.\n* To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data",[767,768,769,770,771,772,773,35,774,775],"Hydrocephalus","Ventriculoperitoneal Shunt Infection","Surgical Site Infection (SSI)","Cerebrospinal Fluid Shunt Infection","Pediatric Hydrocephalus","Hydrocephalus in Children","Hydrocephalus in Infants","Prosthesis-Related Infections","Bacterial Infections and Mycoses",[777,778,779,768,780,781,782,783,784,785,786,787,788,789,136,790,791],"Topical Vancomycin Powder","Vancomycin Crystalline Powder","Biofilm Prevention","Congenital Hydrocephalus","Post-Hemorrhagic Hydrocephalus","Post-Meningitic Hydrocephalus","Cost-Effectiveness","Resource-Limited Settings","Pediatric Neurosurgery","Antibiotic Stewardship","Surgical Site Infection","Antibiotic-Impregnated Catheters","Cerebrospinal Fluid Shunt","VP Shunt Infection","AIC","2026-04-17",{"date":794,"type":48},"2026-04-23",{"date":796,"type":22},"2026-05",{"date":798,"type":22},"2027-12",{"name":800,"class":55},"Assiut University"]