Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-02-11 @ 10:28 PM
Study NCT ID:
NCT03100292
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2017-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean OBEsity Surgical Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight (cm) change', 'timeFrame': 'postoperative 1-year'}, {'measure': 'waist circumference (cm) change', 'timeFrame': 'postoperative 1-year'}], 'secondaryOutcomes': [{'measure': 'remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea)', 'timeFrame': 'postoperative 1-year'}, {'measure': 'Quality of life change', 'timeFrame': 'postoperative 1-year', 'description': 'EuroQol-5D (EQ-5D), the impact of weight on QoL (IWQOL) and the obesity-related psychosocial problem scale (OP-scale) are used to assess the improvement of QoL'}, {'measure': 'Morbidity', 'timeFrame': 'postoperative 1-year'}, {'measure': 'Mortality', 'timeFrame': 'postoperative 1-month'}, {'measure': "Micronutrients' deficiency", 'timeFrame': 'postoperative 1-year', 'description': 'iron, ferritin, calcium, phosphate, albumin, vit.B12, vit.D, and parathyroid hormone'}, {'measure': 'body composition change', 'timeFrame': 'postoperative 1-year', 'description': 'bioelectrical impedance analysis and fat measurement CT'}, {'measure': 'cost-effectiveness', 'timeFrame': 'postoperative 1-year', 'description': 'cost-utility analysis using lifetime expected costs and quality-adjusted life years (QALYs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary bariatric surgery', 'morbid obesity', 'South Korea', 'sleeve gastrectomy', 'Roux-en Y gastric bypass'], 'conditions': ['Bariatric Surgery Candidate', 'Obesity, Morbid']}, 'referencesModule': {'references': [{'pmid': '34355282', 'type': 'DERIVED', 'citation': 'Lee G, Park YS, Cho C, Lee H, Park J, Park DJ, Lee JH, Lee HJ, Ha TK, Kim YJ, Ryu SW, Han SM, Yoo MW, Park S, Han SU, Heo Y, Jung BH. Short-term changes in the serum metabolome after laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Metabolomics. 2021 Aug 5;17(8):71. doi: 10.1007/s11306-021-01826-y.'}, {'pmid': '29042391', 'type': 'DERIVED', 'citation': 'Park YS, Park DJ, Lee JH, Lee HJ, Ha TK, Kim YJ, Ryu SW, Han SM, Yoo MW, Park S, Han SU, Heo Y. Korean OBEsity Surgical Treatment Study (KOBESS): protocol of a prospective multicentre cohort study on obese patients undergoing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. BMJ Open. 2017 Oct 16;7(10):e018044. doi: 10.1136/bmjopen-2017-018044.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. The eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y gastric bypass.\n\nThe primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea\n2. being suitable for general anesthesia\n3. being able to give informed consent and committed to follow-up\n4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.\n\nExclusion Criteria:\n\n1. prior bariatric surgery of any kind\n2. being unable to understand the risks, benefits and compliance requirements of this trial\n3. pregnancy or planning on being pregnancy\n4. non-Korean speaker\n5. American society of anesthesiology (ASA) class IV or higher\n6. malignancy within 5 years.'}, 'identificationModule': {'nctId': 'NCT03100292', 'acronym': 'KOBESS', 'briefTitle': 'Korean OBEsity Surgical Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Efficacy and Safety of Bariatric Surgery for Korean Morbidly Obese Patients : Prospective Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'B-1608/357-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bariatric surgery', 'description': "This trial is a single-arm study and the enrolled patients are going to undergo sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB).\n\nIf the patient has Barrett's esophagus on the preoperative endoscopy, SG is not permitted. Inflammatory bowel disease and Helicobacter pylori infection on a rapid urease test are contraindications of RYGB.", 'interventionNames': ['Other: Sleeve gastrectomy or Roux-en-Y gastric bypass']}], 'interventions': [{'name': 'Sleeve gastrectomy or Roux-en-Y gastric bypass', 'type': 'OTHER', 'armGroupLabels': ['bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Suk Park, M.D.', 'role': 'CONTACT', 'email': 'selteenzeus@gmail.com', 'phone': '+82-31-787-7099'}, {'name': 'Do Joong Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dojoongpark@gmail.com', 'phone': '+82-31-787-7099'}, {'name': 'Yoon-Seok Heo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hyuk-Joon Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sang-Moon Han, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joo Ho Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sang-Uk Han, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung Wan Ryu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moon-Won Yoo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung Ho Choi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tae Kyung Ha, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sung-Soo Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Young Suk Park, M.D.', 'role': 'CONTACT', 'email': 'selteenzeus@gmail.com', 'phone': '+82-31-787-7099'}, {'name': 'Do Joong Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dojoongpark@gmail.com', 'phone': '+82-31-787-7099'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Do Joong Park', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}