- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534504
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients, a Prospective Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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).
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.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jia Gang Han
- Phone Number: 86-10-85231604
- Email: hanjiagang@ccmu.edu.cn
Study Contact Backup
- Name: Zhi Wei Zhai
- Phone Number: 86-10-85231328
- Email: 913916215@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing ChaoYang Hospital
-
Principal Investigator:
- Zhenjun Wang, professor
-
Sub-Investigator:
- Guanghui WEI, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI ≥ 32.5 kg/m2 with or without T2DM;
- 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;
- Duration of T2DM ≤15 years with fasting Cpeptide ≥ 50% of normal lower limit
- Waist circumference: male ≥ 90 cm, female ≥ 85 cm
- Age within 16~65 years old
Exclusion Criteria:
- Pregnancy;
- A history of mental illness and neurological disease;
- The patient refuses surgery;
- Combined with pituitary tumor;
- Long-term use of antidepressant drugs;
- Long-term use of immunosuppressants;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SG-uncut JJB
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.
|
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.
|
Active Comparator: SG-JJB
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
excessive weight loss
Time Frame: 1 year postoperatively
|
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%.
|
1 year postoperatively
|
total weight loss
Time Frame: 1 year postoperatively
|
total weight loss compared with preoperative weight
|
1 year postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 30 days postoperatively
|
Complications within 30 days postoperatively
|
30 days postoperatively
|
operating time
Time Frame: during the operation
|
time from opeing of the operation to the end of the operation
|
during the operation
|
intraoperative blood loss
Time Frame: during the operation
|
blood loss during the operation
|
during the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zhen Jun Wang, Beijing Chao Yang Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SG-uncut JJB 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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