Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT04534504
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'excessive weight loss', 'timeFrame': '1 year postoperatively', 'description': 'Percentage of excess weight loss (EWL) at any time postoperative was calculated as the amount of weight loss divided by the amount of excess weight times 100%.'}, {'measure': 'total weight loss', 'timeFrame': '1 year postoperatively', 'description': 'total weight loss compared with preoperative weight'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '30 days postoperatively', 'description': 'Complications within 30 days postoperatively'}, {'measure': 'operating time', 'timeFrame': 'during the operation', 'description': 'time from opeing of the operation to the end of the operation'}, {'measure': 'intraoperative blood loss', 'timeFrame': 'during the operation', 'description': 'blood loss during the operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleeve gastrectomy', 'Jejunojejunal bypass', 'Weight loss', 'Complication', 'SG-uncut JJB'], 'conditions': ['Excessive Weight Loss', 'Total Weight Loss', 'Sleeve Gastrectomy', 'Jejunojejunal Bypass', 'Uncut']}, 'descriptionModule': {'briefSummary': 'Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).', 'detailedDescription': 'Among various bariatric procedures, sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most frequently performed procedures worldwide. Though SG provides similar weight loss effect to RYGB in short-term follow-up, its long-term and very long-term weight loss effect was reported to be inferior to RYGB. Weight regain after SG remains the major concern after 2-year follow-up due to gradual loss of appetite suppression and lack of malabsorption function. SG plus procedures have been developed to strengthen the effect of SG on diabetes control. It has been reported that SG plus jejunojejunal bypass (SG - JJB) offered better weight loss than SG and similar weight loss to RYGB. The present study aims to evaluate the efficacy and safety of sleeve gastrectomy plus uncut jejunojejunal bypass (SG - uncut JJB).\n\nFor SG-JJB procedure, after SG was finished, the jejunum was transected 20-cm distal to Treiz ligament. After that, another 200-cm jejunum was measured and side-to-side jejunojejunal anastomosis was made. The anastomotic and mesenteric defects were closed by hand suture.\n\nFor SG-uncut JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 32.5 kg/m2 with or without T2DM;\n* 27.5 kg/ m2 \\< BMI \\< 32.5 kg/m2 with T2DM but failed conservative treatment and combined with at least two metabolic diseases or comorbidities;\n* Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit\n* Waist circumference: male ≥ 90 cm, female ≥ 85 cm\n* Age within 16\\~65 years old\n\nExclusion Criteria:\n\n* Pregnancy;\n* A history of mental illness and neurological disease;\n* The patient refuses surgery;\n* Combined with pituitary tumor;\n* Long-term use of antidepressant drugs;\n* Long-term use of immunosuppressants;\n* Situations in which the investigator or other examiner considers from the enrolled study that there are good reasons for nonconformity: if there are potential inconsistencies with the clinical protocol'}, 'identificationModule': {'nctId': 'NCT04534504', 'briefTitle': 'Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients, a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'SG-uncut JJB 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SG-uncut JJB', 'description': 'For SG-uncut JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.', 'interventionNames': ['Procedure: SG-JJB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SG-JJB', 'description': 'For SG-JJB procedure, after SG was finished, the jejunum was transected 20-cm distal to Treiz ligament. After that, another 200-cm jejunum was measured and side-to-side jejunojejunal anastomosis was made. The anastomotic and mesenteric defects were closed by hand suture.', 'interventionNames': ['Procedure: SG-JJB']}], 'interventions': [{'name': 'SG-JJB', 'type': 'PROCEDURE', 'description': 'Base on SG-JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.', 'armGroupLabels': ['SG-JJB', 'SG-uncut JJB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiagang Han, Professor', 'role': 'CONTACT', 'email': 'hjg211@163.com', 'phone': '8613522867841'}, {'name': 'Jiagang Han, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhenjun Wang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guanghui WEI, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia Gang Han', 'role': 'CONTACT', 'email': 'hanjiagang@ccmu.edu.cn', 'phone': '86-10-85231604'}, {'name': 'Zhi Wei Zhai', 'role': 'CONTACT', 'email': '913916215@qq.com', 'phone': '86-10-85231328'}], 'overallOfficials': [{'name': 'Zhen Jun Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhen Jun Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Beijing Chao Yang Hospital, Capital Medical University', 'investigatorFullName': 'Zhen Jun Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}