[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surgery--complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surgery--complications":287},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,38,69,99,122,147,177,209,235,262],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100390749","variability-of-heart-rate-as-a-marker-of-complication-of-colorectal-surgery-100390749",false,"NCT04367987","Variability of Heart Rate as a Marker of Complication of Colorectal Surgery","VFC COLORECTAL","Inclusion Criteria:\n\n* Patients operated for a scheduled colorectal resection due to cancer, diverticulitis, or Chronic Inflammatory Bowel Disease,\n* American Society of Anesthesiologists score 1-2\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* Patient taking antidepressants, antipsychotics, antihypertensive beta blocker type, anti-arythmic or oral contraception\n* Uncontrolled diabetes or associated with a neuropathy\n* Arrhythmias and conduction disturbances, , coronaropathy and heart failure, kidney failure\n* Neuropathies\n* Pacemaker or defibrillator\n* The subject is participating in another interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship","ALL","18 Years",{"count":19,"type":20},117,"ESTIMATED","OBSERVATIONAL","Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.",[24],"Surgery--Complications","RECRUITING","2026-06-15",{"date":28,"type":29},"2026-06-16","ACTUAL",{"date":31,"type":29},"2020-06-17",{"date":33,"type":20},"2027-06",{"name":35,"class":36},"Centre Hospitalier Universitaire de Nīmes","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100437217","vascular-events-in-patients-undergoing-same-day-noncardiac-surgery-valiance-study-100437217","NCT04973397","Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study","Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study - A Prospective Observational Cohort Study Evaluating Major Cardiovascular and Adverse Events in Patients Undergoing Elective Same-day Noncardiac Surgery","VALIANCE","Inclusion Criteria:\n\n* 45-64 years of age with at least one risk factor, or ≥65 years of age;\n* undergoing elective noncardiac same-day surgery;\n* planned duration in the operating room 60 minutes or more;\n* provided written consent.\n\nExclusion Criteria:\n\n* intervention does not require the presence of an anesthesiologist;\n* procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology);\n* intervention is an ophthalmologic procedure;\n* previously enrolled in the VALIANCE study.","45 Years",{"count":48,"type":20},15000,"The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.",[51,24,52],"Preoperative Care","Myocardial Infarction",[51,54,55,56,57,58],"Surgery","Postoperative complications","Same-day surgery","Ambulatory surgery","Outpatient surgery","2026-03-17",{"date":61,"type":29},"2026-03-19",{"date":63,"type":29},"2021-11-17",{"date":65,"type":20},"2027-04",{"name":67,"class":36},"Centre hospitalier de l'Université de Montréal (CHUM)",16,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":37},"100328836","early-phase-1-zinc-oxide-versus-petrolatum-following-skin-surgery-100328836","NCT03561376","Zinc Oxide Versus Petrolatum Following Skin Surgery","Zinc Oxide Versus Petrolatum Following Skin Surgery: A Head-to-head, Prospective, Split-scar Study","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Linear closure, non-scalp site\n3. ≥ 4.5 cm in length (final incision\u002Fclosure length)\n4. End to end symmetry (surgical site is not grossly asymmetric from end to end)\n5. Grossly uninfected site\n\nExclusion Criteria:\n\n1. ≤ 18 years\n2. Visibly asymmetric linear scar\n3. Grossly infected surgical site\n4. History of allergy to topical zinc oxide",true,{"count":78,"type":20},30,"INTERVENTIONAL",[81],"EARLY_PHASE1","Patients undergoing routine surgery in the Department of Dermatology for any indication on non-scalp skin and closed in linear fashion with scar greater than or equal to 4.5cm in length will be invited to participate in this split scar, head to head study comparing zinc oxide and petrolatum. Patients will apply respective ointments to each half of scar daily for one month and maintain a log of these activities. They will be seen at 1 week, 4 weeks, 8 weeks, and 6 months post-operatively for photographic scar assessment and to complete the patient portion of the Patient and Observer Scar Assessment Scale (POSAS), a quantitative objective assessment of scar appearance. Trained observers (board-certified dermatologists) will score the observer portion of the scale. POSAS outcomes, post-operative infections, linear density of epidermal seal will be assessed at the 1 week, 4 weeks, 8 weeks, and 6 months post-operative periods and compared between the two groups. Participants will have parking validated for all visits and upon completion of all portions of the study will receive a standardized skin care gift bag containing samples for hypoallergenic skin care products (washes, moisturizers, etc.).",[84,24,85,86,87,88],"Surgical Incision","Surgical Wound","Surgical Site Infection","Scar","Hypertrophic Scar",[87],"2025-08-12",{"date":92,"type":29},"2025-08-14",{"date":94,"type":29},"2021-09-01",{"date":96,"type":20},"2026-10-30",{"name":98,"class":36},"Melissa Pugliano-Mauro",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":76,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":79,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":37},"100359425","the-impact-of-abdominal-wall-closure-technique-on-incidence-of-incisional-hernia-in-kidney-transplantation-100359425","NCT03959904","The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation","Inclusion Criteria:\n\n* End-stage renal failure patients\n* Aged 18-70yrs\n* First transplants or second transplants\n* Ability to adequately understand English and consent for study\n* BMI\\\u003C35 kg\u002Fm2)\n* Living donor nephrectomy patients Exclusion Criteria\n* Outside age range,\n* Previous transplants which have left a scar in the ilia fossa","70 Years",{"count":107,"type":20},50,[109],"NA","STUDY SUMMARY Incisional hernias, or swellings of the abdominal scar after surgery, remain problematic especially after transplant surgery. This is because they can cause complications, including trapping of bowel or the transplant. This can cause life threatening emergencies but is at the very least unsightly and uncomfortable for the patient. Transplant patients are especially likely to develop hernias because of the diseases causing the renal failure and the drugs that they take to dampen the immune system. There is evidence from other surgery that the stitching methods that are used to close the wounds might decrease the risk of surgical hernias. This is achieved by placing smaller and more numerous sutures (stitches) in the wound to increase the strength of the repair. However, this has never been tested formally in transplant where it may provide significant benefit. We intend to do some initial investigation of whether using the smaller stitches may provide benefit over more traditional methods that are currently being used. We will look at early complications after surgery but also the rate of hernia formation later. We hope to improve outcomes and reduce complications for our transplant patients by doing this. In addition we will collect blood and tissue samples from both live kidney donors and the recipients to microscopically analyse their collagen to identify potential factors which may indicate risk of hernia formation.",[24],"2025-05-08",{"date":114,"type":29},"2025-05-09",{"date":116,"type":29},"2020-03-10",{"date":118,"type":20},"2026-06-30",{"name":120,"class":121},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100456090","reconstruction-in-extended-margin-cancer-surgery-100456090","NCT05219058","Reconstruction in Extended MArgin Cancer Surgery","REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study","REMACS","Inclusion Criteria:\n\n* Male and female patients aged 18 or older\n* Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)\n* Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)\n* Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)\n\nExclusion Criteria:\n\n* Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery\n* Patients that undergo surgery by an intersphincteric abdominoperineal resection approach\n* Patients that are unable to complete the questionnaire over the telephone or online with a researcher\n* Patients unable or unwilling to provide informed consent\n* Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service",{"count":131,"type":20},236,"Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect.\n\nReconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes.\n\nREMACS has three work packages:\n\n1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures.\n2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity.\n3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries.\n\nThe last two work packages have now been funded by an NIHR Research for Patient Benefit Grant",[24,134,135,136],"Pelvic Cancer","Abdominal Cancer","Quality of Life","2025-01-29",{"date":139,"type":29},"2025-01-31",{"date":141,"type":29},"2022-05-17",{"date":143,"type":20},"2028-01-01",{"name":145,"class":36},"University Hospital Southampton NHS Foundation Trust",18,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":37},"100395582","immune-responsiveness-and-outcome-after-aortic-valve-surgery-measure-100395582","NCT04430972","Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)","Is Pre-operative Impaired imMune rEsponsiveness Associated With Adverse Outcome Following Aortic Valve Replacement SURgEry (MEASURE)","Measure","Inclusion Criteria:\n\n• Patients undergoing first-time open aortic valve replacement surgery\n\nExclusion Criteria:\n\n* Age less than 18y (capacity to consent)\n* Ongoing sepsis (immunomodulatory effects, established influence on outcome from surgery)\n* Immunosuppressive therapy\n* Suffering from known immunosuppressive disease\n* Pregnancy (immunosuppressive aspects to pregnancy)",{"count":156,"type":20},150,"There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery.\n\nThe investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery.\n\nThe investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay).\n\nThe investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity.\n\nThe investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study.\n\nImmediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery.\n\nIf the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery.\n\nThis might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)",[159,24,160],"Aortic Valve Disease","Immune System Disorder",[162,163,164,165,166],"staphylococcus","EndoCAb","Immunity","Cardiac Surgical Procedure","sepsis","NOT_YET_RECRUITING","2024-11-15",{"date":170,"type":29},"2024-11-18",{"date":172,"type":20},"2025-09",{"date":174,"type":20},"2026-09",{"name":176,"class":36},"Barts & The London NHS Trust",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":187,"studyType":21,"phases":4,"briefSummary":188,"conditions":189,"keywords":194,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100387938","perioperative-management-evaluation-in-patients-with-cied-100387938","NCT04331249","Perioperative Management Evaluation in Patients With CIED","Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices","EVINCE","Inclusion Criteria:\n\n* implanted CIED (e.g. pacemaker, ICD, CRT),\n* performed (non-CIED related) surgical or catheter-based procedure,\n* data from peri-procedural CIED interrogation available\n* age \\>18 years\n\nExclusion Criteria:\n\n* no implanted CIED,\n* no data from any peri-interventional CIED interrogation available",{"count":186,"type":20},500,"1 Month","Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.\n\nObjective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.\n\nStudy design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics\n\nPrimary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery\u002Fintervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming \u002F device revision).\n\nInclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \\>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available\n\nPatient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \\> 700 interventions are expected.",[190,191,192,193,24],"Cardiac Pacemaker Malfunction","ICD Malfunction","Cardiac Pacemaker Electrical Interference","Anesthesia Complication",[195,196,197,198],"pacemaker","implanted cardioverter defibrillator","cardiac resynchronisation therapy","management, peri-operative","2024-10-11",{"date":201,"type":29},"2024-10-15",{"date":203,"type":29},"2018-11-27",{"date":205,"type":20},"2030-12-31",{"name":207,"class":36},"Klinikum-Fuerth",2,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":217,"studyType":21,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":231,"leadSponsor":233,"locationsCount":37},"100451236","prognostic-factors-in-periampullary-tumors-and-cysts-100451236","NCT05155878","Prognostic Factors in Periampullary Tumors and Cysts","Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region","Inclusion Criteria:\n\n* Recommended surgery for tumor or cyst in the pancreas or periampullary region\n* Information avalible in electronic journal files\n* Informed consent (or deceased for retrospective part of the study)\n\nExclusion Criteria:\n\n* No informed consent (and still alive at study initiation)",{"count":186,"type":20},"10 Years","The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.",[220,221,222,223,224,225,226,54,24],"Pancreas Cancer","Pancreas Neoplasm","Pancreas Cyst","Pancreatic Fistula","Pancreas Disease","Bile Duct Cancer","Periampullary Cancer","2021-12-13",{"date":229,"type":29},"2022-01-05",{"date":94,"type":29},{"date":232,"type":20},"2040-01-01",{"name":234,"class":36},"Umeå University",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":79,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100377797","does-prehabilitation-improve-outcome-in-coloncancer-surgery-100377797","NCT04199208","Does Prehabilitation Improve Outcome in Coloncancer Surgery?","The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study","PRIO","Inclusion Criteria:\n\n* 60 years of older\n* Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)\n* Ventilatory Anaerobic Threshold \\\u003C11mg\u002Fml\u002Fkg\n* Planned open or laparoscopic colectomy due to colon cancer\n\nExclusion Criteria:\n\n* Lower extremity amputee\n* Disease requiring radio- and\u002For chemotherapy prior to surgery\u002Fpalliative disease\n* Distal metastases (Locoregional lymph nodes are OK)","60 Years",{"count":245,"type":20},160,[109],"The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.",[24],[250,251,252],"exercise therapy","perioperative period","coloncancer","2020-04-08",{"date":255,"type":29},"2020-04-09",{"date":257,"type":20},"2020-10-01",{"date":259,"type":20},"2028-01-07",{"name":261,"class":36},"Region Skane",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":79,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":4},"100375426","phase-4-preoperative-intravenous-iron-therapy-in-patients-with-gastric-cancer-100375426","NCT04168346","Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer","IRONSTOMACH","Inclusion Criteria:\n\n\\- Patients with gastric cancer who will undergo a gastrectomy\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients not in full understanding\n* Hemoglobin levels \\> 155 g\u002Fl for women and \\>167 g\u002Fl for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.\n* Transferrin saturation level \\>50%\n* Emergency gastrectomy\n* Palliative gastrectomy\n* Acute bacterial infection\n* Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products\n* Clinical evidence of iron overload or disturbances in the utilisation of iron\n* Patients \\\u003C35 kg\n* Dialysis therapy for chronic renal failure\n* Hemochromatosis\n* Polycythemia vera\n* Pregnancy\n* Patients in need of direct blood transfusion ( Criteria for this are hemoglobin \\\u003C 80 g\u002Fl or \\\u003C 90 g\u002Fl if the patient is symptomatic or has a history of heart disease)",{"count":270,"type":20},202,[272],"PHASE4","The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.",[275,276,54,277,24],"Gastric Cancer","Anemia","Iron Deficiency Anemia","2019-11-16",{"date":280,"type":29},"2019-11-19",{"date":282,"type":20},"2019-11",{"date":284,"type":20},"2026-11",{"name":286,"class":36},"Helsinki University Central Hospital","Surgery- Complications"]