Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02078934
Status:
WITHDRAWN
Last Update Posted:
2020-07-15
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Did not receive funding for recruitment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hernia Repair', 'timeFrame': '3 years', 'description': 'Success of hernia repair'}], 'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '1 Year', 'description': "We will track patient's weight loss after their endoscopic bariatric surgery."}], 'secondaryOutcomes': [{'measure': 'Time to Hernia Repair', 'timeFrame': '1 year', 'description': 'See the time it takes for the patient from the endoscopic surgery to the actual hernia surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgical Endoscopy', 'Morbid Obesity', 'Weight Loss', 'Bariatrics', 'Complex incisional hernia with mesh'], 'conditions': ['Morbid Obesity', 'Weight Loss', 'Complex Incisional Hernias']}, 'referencesModule': {'references': [{'pmid': '23142402', 'type': 'BACKGROUND', 'citation': 'Le Huu Nho R, Mege D, Ouaissi M, Sielezneff I, Sastre B. Incidence and prevention of ventral incisional hernia. J Visc Surg. 2012 Oct;149(5 Suppl):e3-14. doi: 10.1016/j.jviscsurg.2012.05.004. Epub 2012 Nov 9.'}, {'pmid': '23860608', 'type': 'BACKGROUND', 'citation': 'Funk LM, Perry KA, Narula VK, Mikami DJ, Melvin WS. Current national practice patterns for inpatient management of ventral abdominal wall hernia in the United States. Surg Endosc. 2013 Nov;27(11):4104-12. doi: 10.1007/s00464-013-3075-4. Epub 2013 Jul 17.'}, {'pmid': '19879407', 'type': 'BACKGROUND', 'citation': 'Cote GA, Edmundowicz SA. Emerging technology: endoluminal treatment of obesity. Gastrointest Endosc. 2009 Nov;70(5):991-9. doi: 10.1016/j.gie.2009.09.016.'}, {'pmid': '22136774', 'type': 'BACKGROUND', 'citation': 'Familiari P, Costamagna G, Blero D, Le Moine O, Perri V, Boskoski I, Coppens E, Barea M, Iaconelli A, Mingrone G, Moreno C, Deviere J. Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome. Gastrointest Endosc. 2011 Dec;74(6):1248-58. doi: 10.1016/j.gie.2011.08.046.'}, {'pmid': '22178565', 'type': 'BACKGROUND', 'citation': 'Brethauer SA, Chand B, Schauer PR, Thompson CC. Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Relat Dis. 2012 May-Jun;8(3):296-303. doi: 10.1016/j.soard.2011.10.016. Epub 2011 Nov 9.'}, {'pmid': '20947451', 'type': 'BACKGROUND', 'citation': 'Brethauer SA, Chand B, Schauer PR, Thompson CC. Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):689-94. doi: 10.1016/j.soard.2010.07.012. Epub 2010 Aug 6.'}, {'pmid': '23711556', 'type': 'BACKGROUND', 'citation': 'Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair.\n\nHowever, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction.\n\n\\- Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss.\n\nAbu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11\n\nThe intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are:\n\n* Feasibility of endoscopic gastric sleeve plication\n* Define the technical aspects of endoscopic suturing for sleeve plication\n* Provide long-term follow-up for both weight loss and resolution of their co-morbidities\n* Time from the endoscopic procedure to their incisional hernia repair\n* Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair\n\nThere are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14\n\nThe implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ³35 kg/m2\n* Documented incisional hernia\n* Age ≥ 18 years old\n\nExclusion Criteria:\n\n* Prior gastric surgery\n* Prior bariatric surgery\n* Gastroesophageal reflux disease (GERD)\n* Enterocutaneous fistula (ECF)\n* Unable to tolerate general anesthesia\n* Portal Hypertension\n* Underlying coagulopathy'}, 'identificationModule': {'nctId': 'NCT02078934', 'briefTitle': 'Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia', 'orgStudyIdInfo': {'id': 'Endoscopic Gastric Plication'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight Loss', 'description': 'Patients with complex incisional/ventral hernias who are too obese to undergo hernia repair.', 'interventionNames': ['Procedure: Endoscopic Gastric Plication']}], 'interventions': [{'name': 'Endoscopic Gastric Plication', 'type': 'PROCEDURE', 'otherNames': ['Endoscopic Sleeve Plication', 'Apollo Suturing'], 'description': 'Evaluate the efficacy of endoscopic suturing for weight loss', 'armGroupLabels': ['Weight Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Stanley J. Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Jonathan T Carter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Matthew YC Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'John P Cello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}