Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-31 @ 3:18 AM
Study NCT ID:
NCT03983135
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2019-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revisional Bariatric Surgery Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-10', 'studyFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss (kilograms)', 'timeFrame': '3 years', 'description': 'Amount of weight loss (kilograms) before (Day of surgery) and after (At three years) revisional bariatric surgery'}], 'secondaryOutcomes': [{'measure': 'Resolution of comorbidities', 'timeFrame': '3 years', 'description': 'The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about "did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes?"comorbidities at the end of follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Revisional Bariatric Surgery', 'Obesity Associated Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 to 65 years old,\n* Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery\n\nExclusion Criteria:\n\n* Eating disorders,\n* Alcoholic\n* Cancer'}, 'identificationModule': {'nctId': 'NCT03983135', 'briefTitle': 'Revisional Bariatric Surgery Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Results of Revisional Bariatric Surgery: A Single Center Experience', 'orgStudyIdInfo': {'id': 'BakırkoySadiKGeneralSurgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients who undergo revisional bariatric surgery', 'interventionNames': ['Other: Laparoscopic mini gastric by-pass', 'Other: LaparoscopicRe-sleeve gastrectomy', 'Other: Laparoscopic Roux-en-Ygastric bypass']}], 'interventions': [{'name': 'Laparoscopic mini gastric by-pass', 'type': 'OTHER', 'description': 'Adhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches.', 'armGroupLabels': ['Study group']}, {'name': 'LaparoscopicRe-sleeve gastrectomy', 'type': 'OTHER', 'description': 'Adhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie.', 'armGroupLabels': ['Study group']}, {'name': 'Laparoscopic Roux-en-Ygastric bypass', 'type': 'OTHER', 'description': 'all adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall.', 'armGroupLabels': ['Study group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Hakan Seyit', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}