[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"laparotomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:laparotomy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,77,127,153,177,199,228,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639167","phase-2-dexa-vs-dexmedetomidine-with-bupivacaine-in-tap-block-for-laparotomy-analgesia-100639167",false,"NCT07590752","\"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia","Comparison Of Dexamethasone Versus Dexmedetomidine As An Adjuvant To 0.25% Bupivacaine In Ultrasound Guided Tap Block On Post-Op Analgesia Duration In Patients Undergoing Laparotomy","Inclusion Criteria:\n\n* Patients undergoing laparotomy.\n* Patients aged 25 to 65 years.\n* Both genders.\n* Patients with ASA Class I, II.\n\nExclusion Criteria:\n\n* Patients who do not give consent.\n* Patients with Comorbidities like DM, HTN, CKD, CLD.\n* Patients with bleeding disorders.\n* Infection at site of injection.\n* Allergy to any drug, local anaesthetic, or other drugs used.\n* Patients with polytrauma.",true,"ALL","25 Years","65 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","Transversus abdominis plane block is a regional anesthetic technique which blocks the abdominal neural afferents by introducing local anesthetic into the neuro-fascial plane between the internal oblique and the transversus abdominis muscle and gives analgesia from the skin to parietal peritoneum. There are studies showing evidence of improved post operative analgesia with addition of adjuvants such as dexmedetomidine or dexamethasone in comparison with plane local anesthesia in terms of time to rescue analgesia and the overall quantity of analgesic used post operatively.",[29,30,31],"Pain, Postoperative","Opioid Use","Laparotomy","RECRUITING","2026-05-08",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":36},"2024-03-03",{"date":40,"type":22},"2026-07-04",{"name":42,"class":43},"Sahiwal medical college sahiwal","OTHER_GOV",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":44},"100559118","phase-2-iv-vs-epidural-opioids--epidural-local-anesthetic-for-laparotomy-analgesia-100559118","NCT06559969","IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia","Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia","Inclusion Criteria:\n\n1. Age including and between 18 to 85 years old\n2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days\n3. Patient has consented for an epidural\n4. Patient is able to converse in English\n5. Patient is able to use a patient controlled pump\n\nExclusion Criteria:\n\n1. Has a known contraindication for an epidural\n2. Known mental or cognitive disability\n3. History of chronic opioid use or substance abuse disorder\n4. Pre-operative use of opioids\n5. History of chronic pain\n6. Routine use of marijuana\n7. Incarcerated\n8. Unable to converse in English\n9. Planned to remain intubated post-operatively\n10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter\n11. End stage renal disease or dialysis\n12. Hepatic disease that affects metabolism of drugs\n13. Known contraindication to any of the study drugs\n14. Known pregnancy or positive pre-operative pregnancy test\n15. Known neurological condition that may affect motor or sensory systems","18 Years","85 Years",{"count":55,"type":22},80,[25,26],"The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain",[31],[60,61,62,63,64,65,66],"Epidural","PCEA","PCA","Hydromorphone","bupivacaine","analgesia","laparotomy","2026-04-27",{"date":69,"type":36},"2026-04-28",{"date":71,"type":36},"2024-09-17",{"date":73,"type":22},"2027-03-30",{"name":75,"class":76},"University of Iowa","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":107,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":44},"100625999","saudi-emergency-laparotomy-audit-100625999","NCT07429929","Saudi Emergency Laparotomy Audit","Saudi Emergency Laparotomy Audit (SELA): A National Multicenter Observational Audit of Outcomes Following Emergency Laparotomy in Saudi Arabia","SELA","Inclusion Criteria:\n\n* Age ≥14 years\n* Undergoing an emergency (E1-E4) laparotomy, laparoscopy, or laparoscopically-assisted abdominal operation\n* Procedures involving the stomach, small bowel, large bowel, or rectum for acute pathology (e.g., perforation, ischemia, abscess, bleeding, or obstruction)\n* Washout\u002Fevacuation of intra-peritoneal abscess or hematoma (excluding those secondary to appendicitis or cholecystitis)\n* Bowel resection or repair for obstructed\u002Fincarcerated hernias with acute presentation (incisional, umbilical, inguinal, femoral)\n* Adhesiolysis (open or laparoscopic)\n* Trauma-related emergency abdominal procedures\n* Inoperable pathology where a definitive operative procedure was intended (not purely diagnostic)\n* Return to theatre for major wound dehiscence (\"burst abdomen\")\n* Complications requiring general surgical intervention following interventional radiology procedures\n* Complications requiring general surgical intervention following gynecological oncology surgery\n* Complications following elective or non-elective general\u002Fupper GI surgery, where the above criteria are met\n\nExclusion Criteria:\n\n* Age \\\u003C14 years\n* Elective laparotomy or laparoscopy\n* Diagnostic-only laparotomy or laparoscopy (unless abandoned due to inoperable disease)\n* Appendicectomy or cholecystectomy (including their complications), unless incidental to a more major non-elective gastrointestinal procedure\n* Non-elective hernia repair without bowel resection or adhesiolysis\n* Minor wound dehiscence repair (unless bowel resection is required)\n* Stoma formation via trephine or laparoscopic approach (include only if midline laparotomy is the primary procedure)\n* Vascular, obstetric, gynecological (except gynecological oncology complications requiring general surgery input), transplant, hepatobiliary, urological, renal, pancreatic, or splenic procedures","14 Years",{"count":87,"type":22},10000,"OBSERVATIONAL","The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. The audit will collect standardized data on patient characteristics, comorbidities, perioperative processes, and postoperative outcomes through a retrospective baseline phase followed by a prospective registry phase. SELA aims to establish national benchmarks, assess applicability of international risk models, support development of a Saudi-specific risk prediction tool, and drive quality improvement through systematic feedback and benchmarking across participating hospitals.",[31,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Laparotomy Surgery","Emergency Treatment","Abdominal Diseases","Gastrointestinal Diseases","Intestinal Obstruction","Intestinal Obstruction and Ileus","Intestinal Perforation","Intestinal Ischemia","Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications","Peritonitis Bacterial","Peritonitis Caused by Perforated Left-sided Colon Diverticulitis","Peritonitis Infectious","Sepsis","Postoperative Complications After Gastrointestinal Operations","Surgical Procedures, Operative","Mortality",[108,109,110,111,106,112,113,114,115,116],"Emergency laparotomy","Surgical audit","Postoperative outcomes","Perioperative care","Morbidity","Quality improvement","Risk stratification","Retrospective audit","Saudi Arabia","NOT_YET_RECRUITING","2026-02-22",{"date":120,"type":36},"2026-02-24",{"date":122,"type":22},"2026-06-01",{"date":124,"type":22},"2028-12-31",{"name":126,"class":76},"King Faisal Specialist Hospital & Research Center",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100438162","influence-of-analgesic-technique-on-post-operative-rehabilitation-after-median-laparotomy-100438162","NCT04985695","Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy","Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block","QORRECTCATH","Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy\n* Have given an informed written consent\n* Able to read and understand french language\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),\n* Epidural analgesia contraindication\n* With impossibility to set up bilateral rectus sheath block\n* Participation in another clinical study\n* Pregnant women\n* Patients deprived of their liberty by a judicial or administrative decision,\n* Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code",{"count":136,"type":22},110,[138],"NA","Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.",[31],[142],"postoperative rehabilitation","2025-12-09",{"date":145,"type":36},"2025-12-16",{"date":147,"type":36},"2021-10-11",{"date":149,"type":22},"2029-04-10",{"name":151,"class":76},"Centre Hospitalier Régional Metz-Thionville",2,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":44},"100480358","pib-for-post-operative-analgesia-after-laparotomy--determining-the-optimum-dose-100480358","NCT05534945","PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose","Programmed Intermittent Epidural Bolus for Postoperative Analgesia After Laparotomy: Determining the Optimum Dose Using a Biaised Coin Up-and-down Sequential Allocation Protocol","PIBDOSE","Inclusion Criteria:\n\n* 18-85 years old\n* ASA I to III\n\nExclusion Criteria:\n\n* Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal\n* Inability to site the epidural catheter\n* Inability to use PCEA\u002FCommunication barrier\n* Daily opioid use\n* Planned postoperative admission to the intensive care unit\n* Patient refusal\n* Predefined criteria for exclusion after inclusion: Failure to obtain a sensory block to ice in the Post Anesthesia Care Unit (PACU)(see Methods), Reoperation within 1 postoperative day",{"count":162,"type":22},60,[138],"Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions.\n\nTo address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication.\n\nOnly a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision.\n\nHowever, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia.\n\nHence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups.\n\nThe primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day.\n\nSecondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.",[166,31,167],"Acute Post Operative Pain","Epidural Analgesia","2025-11-13",{"date":170,"type":36},"2025-11-14",{"date":172,"type":36},"2022-12-01",{"date":174,"type":22},"2026-12",{"name":176,"class":76},"Ciusss de L'Est de l'Île de Montréal",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":44},"100601427","clinical-outcomes-of-non-indicated-staged-laparotomies-in-abdominal-trauma-100601427","NCT07110350","Clinical Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma","Clinical Characteristics and Outcomes of Non-Indicated Staged Laparotomies in Abdominal Trauma Patients: A Single-Center Retrospective Study","Inclusion Criteria:\n\n* This study included patients with abdominal trauma who were admitted to Far Eastern Memorial Hospital and received exploratory laparotomy between January 1, 2013, and December 31, 2024.\n\nExclusion Criteria:\n\n* Patients who experienced cardiac arrest prior to hospital arrival (OHCA) or in-hospital cardiac arrest (IHCA).\n* Patients with an Abbreviated Injury Scale (AIS) score ≥ 4 in any body region other than the abdomen.\n* Patients who died within 24 hours after the most recent surgical procedure.",{"count":185,"type":22},350,"The goal of this observational study is to understand how often staged operations are performed in abdominal trauma patients without meeting standard clinical criteria, and to explore related clinical characteristics and outcomes. The main questions it aims to answer are:\n\nHow frequently are staged operations performed when not clinically indicated?\n\nWhat are the clinical features and outcomes of patients who undergo non-indicated staged operations?\n\nWhat are the risk factors for delayed reoperation among patients who initially received a single operation?\n\nResearchers will review medical records of patients who underwent exploratory laparotomy for abdominal trauma at Far Eastern Memorial Hospital between January 1, 2013, and December 31, 2024. Participants will be grouped based on whether they had a single or staged operation, and whether their initial operation met established criteria for a staged approach. Clinical characteristics and outcomes will be compared across groups.",[188,189,31],"Abdominal Trauma","Damage Control Surgery","2025-08-05",{"date":192,"type":36},"2025-08-07",{"date":194,"type":22},"2025-08-15",{"date":196,"type":22},"2025-11-30",{"name":198,"class":76},"Far Eastern Memorial Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":44},"100588001","phase-4-intrathecal-morphine-versus-epidural-analgesia-for-open-colon-surgery-100588001","NCT06935708","Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery","Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg\u002Fm2.\n\nExclusion Criteria:\n\n* abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,\n* thrombocytopenia, defined as a platelet count \\\u003C80×10 9 L-1,\n* pre-existing skin infection at the neuraxial anesthesia puncture site,\n* pre-existing neurologic deficit, including peripheral neuropathy,\n* patients with dementia or other medical condition that includes communication difficulties,\n* patients with bradycardia (pulse \\\u003C50\u002Fmin) or with conduction block (2nd or 3rd degree)\n* history of opioid abuse,\n* allergies to any of the drugs used in the study.\n\nAdditionally, patients converted from laparoscopy to laparotomy due to technical surgical issues, patients with postoperative surgical complications (need for revision) or if epidural catheter placement\u002Fspinal anesthesia is unsuccessful even after an attempt by a senior anesthesiologist will also be excluded.","80 Years",{"count":208,"type":22},98,[210],"PHASE4","Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery.\n\nThe investigators expect intrathecal morphine to provide equal pain relief at rest 24 hours after surgery, while epidural analgesia may be more effective during movement. By 48 to 72 hours, both methods should offer similar pain control. The epidural group may require fewer additional pain medications but could experience more side effects, including a higher risk of low blood pressure and technical difficulties. Additionally, these patients may have a slightly longer hospital stay. In contrast, the intrathecal morphine group may have fewer overall side effects. Despite these differences, patient satisfaction, sleep quality, and recovery are expected to be similar in both groups.\n\nBy evaluating these methods, this study aims to determine the most effective and safe approach to post-surgical pain management, improving comfort and recovery outcomes for patients.",[213,214,31],"Colorectal Carcinoma","Analgesia, Postoperative",[216,65,217,218,66],"postoperative pain","epidural","intrathecal morphine","2025-04-18",{"date":221,"type":36},"2025-04-20",{"date":223,"type":36},"2025-04-08",{"date":225,"type":22},"2026-11",{"name":227,"class":76},"Meri Mirceta",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":262},"100382220","phase-3-perioperative-respiratory-care-and-outcomes-for-patients-undergoing-high-risk-abdominal-surgery-100382220","NCT04256798","Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery","PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries","PENGUIN","Inclusion Criteria:\n\n* Adults and children aged 10 years or over\n* Elective or emergency abdominal surgery via midline laparotomy with an anticipated abdominal incision of at least 5cm in length\n* Written informed consent of patient (signature or a fingerprint)\n\nExclusion Criteria:\n\n* Patients undergoing caesarean section\n* Patients with a documented or suspected allergy to chlorhexidine\n* Patient unable to complete postoperative follow-up (not contactable after discharge)\n* Previous enrolment in PENGUIN within the past 30 days\n* American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)","10 Years","100 Years",{"count":239,"type":22},12942,[26],"PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery.\n\nPatients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.",[243,244,245,246,247,248,249,250,251,252,253,31],"Infection","Pneumonia","Surgical Site Infection","Wound Infection","Surgical Wound Infection","Postoperative Complications","Anesthesia","Communicable Disease","Pathologic Processes","Perioperative Complication","Chlorhexidine","2025-02-18",{"date":256,"type":36},"2025-02-19",{"date":258,"type":36},"2020-11-13",{"date":122,"type":22},{"name":261,"class":76},"University of Birmingham",37,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":237,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":44},"100519428","barbed-suture-vs-non-barbed-closure-for-emergency-exploratory-laparotomy-rct-100519428","NCT06043414","Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT","Incisional Surgical Site Infection and Fascial Dehiscence After Abdominal Fascial Closure With Triclosan-Coated Barbed Suture vs Polydioxanone Suture After Emergency Exploratory Laparotomy: A Randomized Control Trial","Inclusion Criteria:\n\n* All adult individuals aged 18 years or older who undergo emergent laparotomy via a midline approach for trauma or non-trauma emergency general surgery who undergo complete fascial closure at the time of the index laparotomy operation.\n* Individuals with CDC Class I, II, III and IV type surgical wounds\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Individuals with known immune deficiencies\n* Individuals taking chronic immunosuppressive medications\n* Individuals presenting with nosocomial infections\n* Individuals presenting with pre-existing abdominal wall hernia\n* Individuals requiring multiple operations for sequential fascial closure\n* Individuals incarcerated at time of operation\n* Individuals with known preexisting connective tissue disease\n* Individuals with known preexisting ventral abdominal wall hernia\n* Individuals who are pregnant time of operation\n* Individuals who are deceased prior to conclusion of exploratory laparotomy\n* Individuals lost to follow-up or deceased during the first 30 days after laparotomy.",{"count":271,"type":22},250,[138],"This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia after emergency exploratory laparotomy. The study addresses the common complications of incisional surgical site infections (SSI) and fascial dehiscence (FD) following emergency exploratory laparotomy. The primary objective is to assess the effectiveness of triclosan-coated barbed suture and conventional non-barbed suture in reducing the rates of incisional SSI and FD within 30 days postoperatively. The study population comprises adult patients undergoing emergent laparotomy for traumatic injuries or acute intraabdominal pathology. This prospective, single-blinded randomized control trial will be conducted at Los Angeles General Medical Center. Patients will be randomized to receive either triclosan-coated barbed suture or conventional non-barbed suture for abdominal fascial closure, with a standard closure technique employed. Patients will be followed up for 30 days postoperatively to monitor surgical site infections, fascial dehiscence, and other outcomes. Statistical analysis will be conducted to compare outcomes between the study arms, assessing the efficacy of triclosan-coated barbed suture in reducing the incidence of SSI and FD, along with secondary outcomes.",[31,275,276,277,278],"Dehiscence Wound","Surgical Site Infections","Trauma Abdomen","Emergency General Surgery",[280,281,66,282,283,284,285],"fascial dehiscence","surgical site infection","ex-lap","STRATAFIX","PDS","triclosan-coated barbed suture","2023-11-27",{"date":288,"type":36},"2023-11-28",{"date":290,"type":22},"2024-01-01",{"date":292,"type":22},"2027-01-31",{"name":294,"class":76},"University of Southern California"]