[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"incisional-hernia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:incisional-hernia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,50,90,113,143,178,202,223,247,275,298,327,353,372],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100638469","ap-noses-a-prospective-multicentre-registry-of-natural-orifice-specimen-extraction-in-minimally-invasive-colorectal-surgery-100638469",false,"NCT07615036","AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery","AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region","AP-NOSES","Inclusion Criteria:\n\n* Age 21 years or older\n* Elective minimally invasive colorectal resection (laparoscopic or robotic intent)\n* Planned intact specimen extraction\n* Eligible for natural orifice specimen extraction (NOSE) or transabdominal specimen extraction according to study protocol\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Emergency colorectal surgery\n* Planned transanal total mesorectal excision (TaTME)\n* Planned ultralow anterior resection with planned anastomosis 3 cm or less from the anal verge\n* Planned abdominoperineal resection (APR)\n* Planned permanent end stoma without restoration of intestinal continuity\n* Planned multivisceral resection\n* Generalized peritonitis or uncontrolled intra-abdominal sepsis\n* Pregnancy\n* Pre-existing ventral or incisional hernia at the planned extraction site\n* Planned specimen extraction through a prior laparotomy incision containing mesh\n* Fixed distal obstruction, severe pelvic stenosis, or other anatomical constraint precluding intact specimen extraction","ALL","21 Years",{"count":20,"type":21},800,"ESTIMATED","OBSERVATIONAL","Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited.\n\nAP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction.\n\nSecondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers.\n\nThis study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.",[25,26],"Colorectal Neoplasms","Incisional Hernia",[28,29,30,31,32,33,34,35,36],"Natural Orifice Specimen Extraction","NOSE surgery","Minimally invasive colorectal surgery","Incisional hernia","Laparoscopic colorectal surgery","Transanal specimen extraction","Transvaginal specimen extraction","Patient-reported outcomes","Prospective registry","RECRUITING","2026-05-22",{"date":40,"type":41},"2026-05-29","ACTUAL",{"date":43,"type":41},"2026-05-05",{"date":45,"type":21},"2033-12-30",{"name":47,"class":48},"Singapore General Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100417629","gore-enform-biomaterial-product-study-100417629","NCT04718168","GORE® ENFORM Biomaterial Product Study","GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients","ENF 18-06","Pre-procedure Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).\n2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.\n3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.\n4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.\n5. Willing to provide informed consent and comply with follow-up requirements.\n\nPre-procedure Exclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.\n\nPost-procedure Inclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. At least 18 years old. Minimum age required by state regulations (as applicable).\n2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.\n3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.\n\nPost-procedure Exclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Underwent mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.","18 Years",{"count":60,"type":21},245,"INTERVENTIONAL",[63],"NA","A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral \u002F Incisional Hernia Repair and Diaphragmatic \u002F Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.",[66,67,68,26],"Hernia, Ventral","Hernia, Hiatal","Hernia, Diaphragmatic",[70,71,72,73,74,75,76,77,78],"hernia","ventral","hiatal","diaphragmatic","incisional","mesh","Gore","W.L. Gore","Enform","2026-02-17",{"date":81,"type":41},"2026-02-18",{"date":83,"type":41},"2021-05-17",{"date":85,"type":21},"2026-09",{"name":87,"class":88},"W.L.Gore & Associates","INDUSTRY",9,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":61,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100485336","suture-repair-vs-mesh-repair-for-incisional-hernia-100485336","NCT05599750","Suture Repair vs Mesh Repair for Incisional Hernia","A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia","Inclusion Criteria:\n\n* Adults \\>18 years old.\n* Anticipated hernia defect 2-6cm in width\n* Non-emergent case\n* CDC class I\n* Patients who previously underwent primary ventral hernia repair without the use of mesh\n* Incisional hernia\n\nExclusion Criteria:\n\n* Emergent cases\n* Patients \\\u003C 18 years old\n* Patients who are pregnant\n* Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.\n* Ventral hernia \\\u003C2cm or \\> 6 cm in width\n* Primary hernia\n* CDC wound class II-IV",true,{"count":99,"type":21},154,[63],"The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.\n\nThe main question it aims to answer are:\n\n• Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.",[26],"2026-01-05",{"date":105,"type":41},"2026-01-07",{"date":107,"type":41},"2022-11-14",{"date":109,"type":21},"2031-10",{"name":111,"class":48},"Clayton Petro",5,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":61,"phases":122,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100593243","treating-emergency-laparotomy-incisions-with-negative-pressure-wound-therapy-100593243","NCT07003906","Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy","TELIN","Inclusion Criteria:\n\n* ≥18 years old\n* Written informed consent\n* \\>10 cm midline incision with primary skin closure\n* Emergency laparotomy\n\nExclusion Criteria:\n\n* Not able to consent (e.g. dementia, impaired cognitive function, unconscious)\n* Subjects not possible to follow up as assessed by the Investigator\n* Allergy to dressing material\n* Pregnancy or breastfeeding (females of childbearing potential)\n* Previous enrolment in the current study\n* Expected reoperation with 28 days of index laparotomy\n* Emergency laparotomy within 3 months",{"count":121,"type":21},720,[63],"The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is:\n\nDoes NPWT decrease wound complications?\n\nResearchers will compare it against regular dressings to see if NPWT is superior.",[125,126,127,26,128],"Surgical Incision","Wound Dehiscence","Surgical Site Infection","Quality of Life",[130,131,132],"emergency surgery","negative pressure wound therapy","randomised controlled trial","2025-12-18",{"date":135,"type":41},"2025-12-26",{"date":137,"type":41},"2025-12-16",{"date":139,"type":21},"2035-12",{"name":141,"class":48},"Uppsala University",6,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":61,"phases":154,"briefSummary":155,"conditions":156,"keywords":161,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":49},"100614544","comparing-polyglactin-vs-polypropylene-sutures-for-rectus-sheath-closure-100614544","NCT07280975","Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure","Comparative Outcomes of Polyglactin Versus Polypropylene Sutures for Rectus Sheath Closure: A Randomized Controlled Trial","PolySuture","Inclusion Criteria:\n\n1. Age: 18-70 years.\n2. Type of Surgery: Patients undergoing elective or emergency midline laparotomy.\n3. Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).\n4. Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.\n5. Availability for Follow-Up: Participants must be available for 6 months follow-up.\n\nExclusion Criteria:\n\n1. Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.\n2. Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.\n3. Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.\n4. Severe Malnutrition: Patients with BMI \\\u003C 16 kg\u002Fm² or albumin \\\u003C 2.5 g\u002FdL.\n5. Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.\n6. Pregnancy: Pregnant women.\n7. Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.","70 Years",{"count":153,"type":21},156,[63],"This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.",[157,126,158,26,159,160],"Chronic Pain","Surgical Site Infection (SSI)","Rectus Sheath Closure","Abdominal Surgery",[162,163,164,165,166],"Polyglactin Sutures","Polypropylene Sutures","Non-Absorbable Sutures","Postoperative Complications","Midline Laparotomy","NOT_YET_RECRUITING","2025-12-09",{"date":170,"type":41},"2025-12-15",{"date":172,"type":21},"2026-04-01",{"date":174,"type":21},"2027-07-30",{"name":176,"class":177},"Lady Reading Hospital, Pakistan","OTHER_GOV",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":49},"100607778","does-preoperative-physical-activity-predict-postoperative-complications-after-incisional-hernia-repair--100607778","NCT07192978","Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?","EVENTEST","Inclusion Criteria\n\n* Adult (≥18 years old)\n* Subject operated on at the HUS between January 6, 2021 and October 24, 2024\n* Midline eventration\n* Placement of a prosthetic reinforcement\n\nExclusion Criteria\n\n\\- Subject (and\u002For their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes",{"count":186,"type":21},100,"Patients with abdominal wall incisional hernia often have numerous comorbidities, making management complex.\n\nTo date, no study has described the relationship between preoperative physical activity and the occurrence of complications, particularly severe ones, after incisional hernia repair.\n\nThe research hypothesis is that \"patient fragility\" related to physical inactivity and comorbidities is a poor prognostic factor for the occurrence of complications after incisional hernia repair and a source of more severe complications.",[26],[26,190,191,192],"Laparotomy","Comprehensive Complication Index","Clavien-Dindo classification","2025-09-23",{"date":195,"type":41},"2025-09-25",{"date":197,"type":41},"2025-09-09",{"date":199,"type":21},"2026-09-09",{"name":201,"class":48},"University Hospital, Strasbourg, France",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":97,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":49},"100574690","prophylactic-mesh-reinforcement-after-open-aortic-aneurysm-repair-100574690","NCT06762561","Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair","Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study","Inclusion Criteria:\n\n* Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024\n* Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data\n* Attendance at a clinical follow-up examination at least one year after the procedure\n* General informed consent signed for the use of medical data for research purposes\n\nExclusion Criteria:\n\n* Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data\n* Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.\n* Patients who did not attend the required clinical follow-up examination at least one year postoperatively.",{"count":210,"type":21},20,"The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:\n\n* Does mesh reinforcement reduce the incidence of incisional hernias?\n* What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.\n\nParticipants will:\n\n* Undergo clinical follow-ups and abdominal ultrasounds to detect IH.\n* Complete quality-of-life questionnaires (EQ-5D and PROMIS).",[26,213],"Aortic Aneurysm","2025-06-02",{"date":216,"type":41},"2025-06-03",{"date":218,"type":21},"2025-06-01",{"date":220,"type":21},"2026-10-31",{"name":222,"class":48},"Hôpital Fribourgeois",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":61,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100544086","open-versus-robotic-retromuscular-repair-in-medium-to-large-ventral-hernias-100544086","NCT06364306","oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias","oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial","PRIOR","Inclusion Criteria:\n\n* Patient age \\>18 years\n* Informed consent obtained\n* Transverse diameter of ventral hernia \\>4cm - 15cm\n* Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment\n\nExclusion Criteria:\n\n* precedent hernia treatment with mesh placement in the retromuscular space\n* precedent anterior or posterior component separation or transversus abdominis release (TAR)\n* active wound infection\n* current cancer diagnosis\n* presence of ileostomy, colostomy or ileal conduit\n* liver disease defined by the presence of ascites\n* end-stage renal disease requiring dialysis\n* need of an emergency surgery\n* pregnancy\n\nCriteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.",{"count":232,"type":21},140,[63],"This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.\n\nThe goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).\n\nThe main questions it aims to answer are:\n\nlength of stay after the operation rate of complications rate of recurrence and reoperations quality of life.\n\nParticipants will:\n\nEither be operated using the RVHR or OVHR will be followed up either in person or via email \u002F phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.",[236,26,237],"Ventral Hernia","Abdominal Wall Defect","2025-04-15",{"date":240,"type":41},"2025-04-18",{"date":242,"type":21},"2025-10-01",{"date":244,"type":21},"2031-12-31",{"name":246,"class":48},"University Hospital, Basel, Switzerland",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":61,"phases":258,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":49},"100554456","phase-3-surgery-with-botulinum-toxin-a-for-incisional-hernia-100554456","NCT06499324","Surgery with Botulinum Toxin a for Incisional Hernia","Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial","INCISOX","Inclusion Criteria:\n\n1. Patients between 18 and 79 years;\n2. BMI \\\u003C 35 kg\u002Fm²;\n3. Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width \\>= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3);\n4. IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) \u002F (total peritoneal volume) \\\u003C 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion;\n5. Written informed consent;\n6. Scheduled surgery for an open IH repair;\n7. For female of childbearing potential: using highly effective contraception.\n\nExclusion Criteria:\n\n1. Other types of IH (lateral, groin, para-stomal, portsite);\n2. VHWG grades 3 or 4 for the risk of surgical site infection;\n3. Ongoing skin infection or inflammation at the IH site or at the BTA injection site;\n4. Planned IH repair with slowly absorbable mesh;\n5. IH with loss of domain (volumetric ratio \\> 25%);\n6. Emergency IH surgery;\n7. ASA score \\> 3;\n8. Pregnancy or breastfeeding;\n9. Ongoing treatment with aminoglycosides;\n10. Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;\n11. Active tobacco use (or cessation inferior to 3 months);\n12. Use of another investigational product within 6 months or 5 half-lives (whichever is longer), or currently participating in a prospective study with an investigational product, whether it concerns an experimental drug or a medical device;\n13. Patient not covered by social insurance;\n14. Patient under legal guardianship;\n15. Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose);\n16. Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome, peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy), facial nerve disorders, underlying neurological disorders) and history of dysphagia and aspiration);\n17. Patient with ongoing treatment with medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. tubocurarine-type muscle relaxants that weaken the muscles;\n18. Patient with severe and uncontrolled cardiovascular diseases;\n19. Patient has received BTA within 12 weeks;\n20. Patients with a history of seizures.","79 Years",{"count":257,"type":21},260,[259],"PHASE3","After laparotomy, treating large incisional hernias (width \\>= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing normal anatomy by bringing muscles together may be impossible, leading to the use of complex procedures like component separation techniques (CST), involving large aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA) induces reversible flaccid paralysis, with potential benefits in hernia closure, known as \"chemical CST.\" Retrospective studies suggest reduced muscle retraction and facilitated closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical morbidity compared to repair and CST. The prospective evaluation of BTA's clinical benefits, including reduced postoperative morbidity, pain, successful abdominal closure, and decreased IH recurrence risk, is lacking. A prospective randomized double-blind placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is that BTA injection before IH repair is more effective than a placebo in reducing postoperative morbimortality. Secondary expectations include a significant reduction in complete closure of the abdominal wall without CST.",[26],[26,263,264,265],"Botulinum toxin A","Incisional Hernia repair","Laparatomy","2025-01-20",{"date":268,"type":41},"2025-01-22",{"date":270,"type":41},"2025-01-17",{"date":272,"type":21},"2029-03-04",{"name":274,"class":48},"Assistance Publique - Hôpitaux de Paris",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":61,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":49},"100423494","prevention-of-incisional-hernia-after-renal-transplantation-100423494","NCT04794582","Prevention of Incisional Hernia After Renal Transplantation","Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh","Inclusion Criteria:\n\n* Candidate for first kidney transplant\n\nExclusion Criteria:\n\n* Patient receiving a second or successive renal transplant.",{"count":283,"type":21},160,[63],"Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.",[26,287,165],"Kidney Transplantation",[26,287],"2024-11-20",{"date":291,"type":41},"2024-11-22",{"date":293,"type":41},"2022-08-31",{"date":295,"type":21},"2026-12",{"name":297,"class":48},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":61,"phases":308,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":49},"100532995","comparing-polypropylene-mesh-and-small-bites-technique-in-emergency-colorectal-surgerys-midline-laparotomy-closure-study-for-incisional-hernia-prevention-100532995","NCT06220058","Comparing Polypropylene Mesh and \"Small Bites\" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.","Comparison Between the Use of a Prophylactic Polypropylene Mesh and the \"Small Bites\" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention","BITEME","Inclusion Criteria:\n\n* Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.\n* Patients undergoing urgent laparoscopic surgery but necessitating conversion to midline laparotomy.\n* Urgent surgical intervention required at the level of the colon and\u002For rectum, even in the presence of other abdominal pathologies.\n* Age over 18 years.\n* Signed informed consent (IC) from the patient and the investigator.\n\nExclusion Criteria:\n\n* Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.\n* BMI ≥ 35 kg\u002Fm2.\n* Re-laparotomies.\n* Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.\n* Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).",{"count":307,"type":21},148,[63],"The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (\\>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.",[311,26,312],"Colorectal Cancer","Wound Infection",[314,315,316,317],"colorectal cancer","Hernia Incisional","Wound infection","small bites","2024-10-06",{"date":320,"type":41},"2024-10-08",{"date":322,"type":41},"2024-02-05",{"date":324,"type":21},"2027-01-15",{"name":326,"class":48},"Fernandez Zamora",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":97,"sex":17,"minAge":58,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":61,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100416172","trocar-site-incisional-hernia-prevention-100416172","NCT04699201","Trocar Site Incisional Hernia Prevention","Prevenció De L'Hèrnia Incisional Per Tròcar","PHIT","Inclusion Criteria:\n\n* Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital\n* ASA (American Society of Anesthesiologists) \\\u003CIV\n\nExclusion Criteria:\n\n* Allergy or intolerance to any of the mesh components\n* Patients presenting already primary or incisional hernia of the abdominal wall\n* ASA ≥IV\n* Intraoperative conversion to laparotomy\n* Emergency surgery\n* Pregnancy","99 Years",{"count":337,"type":21},94,[63],"Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery.\n\nMethods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months.\n\nAn ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination.\n\nRelevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique.\n\nThere are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.",[26],[342],"Incisional Hernia, Umbilical Trocar, Preventive mesh","2024-10-01",{"date":345,"type":41},"2024-10-02",{"date":347,"type":41},"2021-03-02",{"date":349,"type":21},"2025-02",{"name":351,"class":48},"Hospital Universitari Joan XXIII de Tarragona.",2,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":255,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":49},"100485076","incisional-hernia-digestion-sexuality-100485076","NCT05596357","Incisional heRnia dIgestion Sexuality","Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life , Digestive and Sexual Functions.","IRIS","Inclusion Criteria:\n\n* Patients aged 18 to 79\n* No opposition to research\n* Planned surgery to cure a hernia or complex anterior eventration of the abdomen by laparotomy or laparoscopy\n* Mastery of the French language sufficient to answer questionnaires\n\n  * Registration in a national health care system\n\nExclusion Criteria:\n\n* Emergency surgery\n* ASA (American Society of Anesthesiologists) score\\> 3 during the preoperative consultation\n* Current pregnancy or breastfeeding\n* Patient under guardianship or curatorship\n* Patient under AME (State Medical Aid)",{"count":186,"type":21},"After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients",[26],"2023-09-06",{"date":366,"type":41},"2023-09-08",{"date":368,"type":41},"2023-07-10",{"date":370,"type":21},"2030-03-01",{"name":274,"class":48},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":61,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":4},"100482915","vacuum-assisted-wound-closure-and-permanent-on-lay-mesh-mediated-fascial-traction-in-patients-with-open-abdomen-100482915","NCT05568238","Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen","Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study","VAWCPOM","Inclusion Criteria:\n\n• All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.\n\nExclusion Criteria:\n\n* Patient declining participation\n* Existing incisional hernia or primary ventral hernia ≥3 cm\n* Existing mesh in the abdominal wall, located in the midline and irrespective of mesh size\n* Existing ostomy\u002Fparastomal hernia located in a position that prevents the VAWCPOM technique to be utilized\n* Closure of the abdomen at first dressing change, e. g. without mesh traction",{"count":186,"type":21},[63],"Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.\n\nHypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.\n\nAims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.\n\nDesign A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.",[384,385,26],"Open Abdomen","Temporary Abdominal Closure","2022-09-30",{"date":388,"type":41},"2022-10-05",{"date":390,"type":21},"2022-10",{"date":392,"type":21},"2027-12",{"name":394,"class":48},"Skane University Hospital"]