Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-27 @ 11:24 AM
Study NCT ID:
NCT04554758
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative double arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-13', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obesity Cure Success Rate', 'timeFrame': 'Postoperative 1 year', 'description': 'Proportion of patients who reach BMI bellow 25'}, {'measure': 'Body weight change rate', 'timeFrame': 'Postoperative 1 year', 'description': 'Decreased body weight proportion compare to preoperative body weight'}, {'measure': 'Waist circumference change rate', 'timeFrame': 'Postoperative 1 year', 'description': 'Decreased waist circumference change proportion compare to preoperative waist circumference'}], 'secondaryOutcomes': [{'measure': 'Rate of morbid disease remission or partial remission', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': 'Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery'}, {'measure': 'Postoperative complication rate and mortality rate', 'timeFrame': 'Within postoperative 30 days', 'description': 'Number of participants surgical complications associate with the surgical technique or the operation field Number of participants mortality after operation associated with surgical complication or underlying disease'}, {'measure': 'Micronutrient deficiency', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': 'Incidence of micronutrient deficiency rate such as vitamine, calcium, iron'}, {'measure': 'Quality of life improvement rate and degree-1', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': 'Patients rate and quantitative analysis of the improved life quality using several survey EQ-5D-3L(EuroQol-5D) consists of 5 dimensions(mobility, self-care, usual activities, pain/discomfort and anxiety/depression).\n\nEach of which is scored as no/some/extreme problems. The dimension scores are converted into health utility scores ranging form 0(death) to 1(perfect health)'}, {'measure': 'Quality of life improvement rate and degree-2', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': "EQ-VAS(EuroQol-Visual Analogue scale) is a question scale ranging form 0 to 100.\n\n0 indicated the worst and 100 indicated the best condition. EQ-VAS provides important, complementary information on patient's view about their own health."}, {'measure': 'Quality of life improvement rate and degree-3', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': 'Impact of Weight on QoL(IWQoL) has 5 dimensions and each dimension has several items.\n\n* physical function : 11 items\n* self-esteem : 7 items\n* sexual life : 4 items\n* public distress : 5 items\n* work : 4 items\n\nScore range from 0 to 100 and 100 represents the best quality of life.'}, {'measure': 'Quality of life improvement rate and degree-4', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': 'Moore-head-Ardelt QoL questionnaire II(MA-II) has 6 items(general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior).\n\nAll items are scored according to 10-level Likert scale(-0.5 to 0.5) and all have the same weight.'}, {'measure': 'Quality of life improvement rate and degree-5', 'timeFrame': 'Postoperative 1 year, 2 year', 'description': "Obesity-related Psychosocial Problem scale(OP scale) consists of 8 items that measure the bothersome impact of body weight on given situations.\n\n(private gatherings in their own home, private gatherings at their friend or relative's home and going to restaurant)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary bariatric surgery', 'morbid obesity', 'sleeve gastrectomy', 'Roux-en Y gastric bypass', 'South Korea'], 'conditions': ['Obesity, Morbid', 'Overnutrition', 'Nutrition Disorders', 'Overweight and Obesity', 'Body Weight Changes']}, 'descriptionModule': {'briefSummary': 'Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass', 'detailedDescription': "This is prospective cohort study. Total 400 obese patients will be enrolled(Sleeve gastrectomy 200 patients, Roux-en-Y gastric bypass 200)\n\nThe principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method.\n\nAbout 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5.\n\nAll patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery.\n\nPatients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test.\n\nSurgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia.\n\nSystemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others.\n\nHospital mortality is defined as postoperative death form any cause within 30 days after operation.\n\nAll patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month.\n\nAll patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation.\n\nAll patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity patients(BMI over 35)\n* morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea\n* type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%\n\nExclusion Criteria:\n\n* Patients who underwent previously bariatric operation\n* Patients who were diagnosed malignant disease patients within 5 years\n* Patients who were involved with other clinical trial within 3 months\n* Patients who are risky to conduct general anesthesia for operation'}, 'identificationModule': {'nctId': 'NCT04554758', 'briefTitle': 'Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'Korean OBEsity Surgical Treatment Study(KOBESS-II) : Protocol of a Prospective Multicenter Cohort Study on Morbid Obesity Patients Undergoing Sleeve Gastrectomy Versus Roux-en Y Gastric Bypass', 'orgStudyIdInfo': {'id': 'KOBESS-II trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleeve gastrectomy', 'description': '200 obesity patients who undergo laparoscopic sleeve gastrectomy', 'interventionNames': ['Procedure: Sleeve gastrectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Roux-en-Y gastric bypass', 'description': '200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass', 'interventionNames': ['Procedure: Roux-en-Y gastric bypass']}], 'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.', 'armGroupLabels': ['Sleeve gastrectomy']}, {'name': 'Roux-en-Y gastric bypass', 'type': 'PROCEDURE', 'description': 'Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.', 'armGroupLabels': ['Roux-en-Y gastric bypass']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoon Seok Heo, Professor', 'role': 'CONTACT', 'email': 'gsheo@inha.ac.kr', 'phone': '+82-32-890-3435'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Yoon Seok Heo, Professor', 'role': 'CONTACT', 'email': 'gsheo@inha.ac.kr', 'phone': '+82-32-890-3437'}, {'name': 'Yun Suk Choi, Instructor', 'role': 'CONTACT', 'email': 'yunsukki@gmail.com', 'phone': '+82-32-890-3437'}], 'overallOfficials': [{'name': 'Yoon Seok Heo, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}, {'name': 'Do Joong Park, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Yong Suk Park, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Seung Wan Ryu, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Keimyung University Hospital'}, {'name': 'Moon Won Yoo, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan univertisy Seoul Asan Medical Center'}, {'name': 'Han Hong Lee, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Catholic University of Korea'}, {'name': 'Ji Yeon Park, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'Sang Hyun Kim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Jong Won Kim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chung-Ang University Hopspital'}, {'name': 'Jong Han Kim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Korea University Medical Center(Guro Hospital)'}, {'name': 'In Seob Lee, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan univertisy Seoul Asan Medical Center'}, {'name': 'In Gyu Kwon, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yonsei University Medical Center(Gangnam Hospital)'}, {'name': 'Tae Kyung Ha, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hanyang University'}, {'name': 'Sung Il Choi, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}, {'name': 'Kyung Won Seo, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kosin University Gospel Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yoonseok Heo', 'investigatorAffiliation': 'Inha University Hospital'}}}}