Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT07180316
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': '12 month', 'description': 'The complications routinely screened for are: gastrointestinal fistulas (gastrojejunal anastomosis fistula, excluded gastric fistula, and loop foot fistula), bruit, anastomotic stenosis, anastomotic ulcer, splenic infarction, the development of a deep abdominal collection, and pulmonary and cardioembolic complications.\n\nThe diagnosis of gastrointestinal fistula will be made in the event of signs of sepsis associated with the presence of an intra-abdominal collection on CT scan, the need for intravenous antibiotics with strict fasting and exclusive parenteral nutrition, and/or the need for surgical exploration.\n\nDepression is defined as the postoperative need for blood transfusion, with a drop in hemoglobin levels of at least 2.5 g/dL compared to the preoperative level. Postoperative complications will be obtained according to the Clavien Dindo classification'}], 'secondaryOutcomes': [{'measure': 'Post-operative PAIN', 'timeFrame': 'Day 2', 'description': 'Post-operative pain will be assessed by a simple numerical scale rated from 0 (no pain) to 10 (worst pain ever experienced).'}, {'measure': 'The total duration of the surgical procedure', 'timeFrame': 'Day 2', 'description': 'Duration of anesthesia, duration of the surgical procedure,Length of stay in the Post-Anesthesia Care Unit, Time from end of surgery to first mobilization, Time from end of surgery to hospital discharge will be collected and compared between the two groups.'}, {'measure': 'Weight loss', 'timeFrame': '12 month', 'description': 'BMI will be collected during follow-up, and weight loss will be compared between the two groups.'}, {'measure': 'Evolution of comorbidities', 'timeFrame': '12 month', 'description': 'The occurrence, worsening, or resolution of the following comorbidities will be recorded:\n\n* Diabetes: type 1 or type 2\n* Arterial hypertension\n* Dyslipidemia\n* Obstructive sleep apnea syndrome (OSAS) or other severe obesity-related respiratory disorders\n* Chronic osteoarticular conditions\n* NASH (non-alcoholic steatohepatitis) or other metabolic liver diseases\n* Metabolic syndrome (defined as the presence of at least three of the following metabolic abnormalities: increased waist circumference, hyperglycemia, hypertension, hypertriglyceridemia, low HDL cholesterol)\n* Nephropathy\n* PCOS (Polycystic Ovary Syndrome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric revision surgery.', 'Laparoscopy', 'Robotic surgery'], 'conditions': ['Obesity and Overweight', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'In a population of patients undergoing bariatric revision surgery with conversion to RYGB and divided into two groups according to the surgical protocol:\n\nGroup 1: robotic surgery Group 2: laparoscopy\n\nThe primary objective of the study is to compare the rates of postoperative complications between the two groups, classified according to the Clavien Dindo classification. The secondary objectives are to compare between the groups:\n\n* Total duration of the surgical procedure, stay in the emergency room, and hospitalization\n* Postoperative pain\n* Adverse events\n* Weight loss\n* Improvement in comorbidities', 'detailedDescription': 'The study procedures are the usual procedures of investigators who usually perform bariatric revision surgery. There is no change from the usual care. Participation in the study does not alter the benefit/risk ratio of the surgical procedure, does not alter the usual follow-up of patients who have undergone this type of surgery, and does not collect data other than those usually collected as part of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing revision bariatric surgery with conversion to RYGB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 70 years,\n* Patients who have been informed of the objectives and conditions of the study and who have not objected to the collection of their data\n* Patients who are candidates for or have undergone revision bariatric surgery with conversion to RYGB (post-ring, post-sleeve, post-OAGB)\n\nExclusion Criteria:\n\n* Pregnant patient\n* Patient unable to understand information: dementia, psychosis, impaired consciousness, language difficulties'}, 'identificationModule': {'nctId': 'NCT07180316', 'acronym': 'ROLAP', 'briefTitle': 'Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery', 'orgStudyIdInfo': {'id': '2023-06-033-ERAME0598'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LAPAROSCOPY SURGERY'}, {'label': 'ROBOTIC SURGERY'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aminah Dr EL BOUYOUSFI', 'role': 'CONTACT', 'email': 'dr.elbouyousfi@centrechirurgical.fr', 'phone': '04 28 63 69 69', 'phoneExt': '+33'}], 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42100', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Dr Filippello', 'role': 'CONTACT', 'email': 'alexandre.filippello@orange.fr', 'phone': '04 77 42 27 00', 'phoneExt': '+33'}], 'facility': 'Hôpital privé de la Loire - Ramsay Santé', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}