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Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients

Primary Purpose

Excessive Weight Loss, Total Weight Loss, Sleeve Gastrectomy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SG-JJB
Sponsored by
Zhen Jun Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Weight Loss focused on measuring sleeve gastrectomy, Jejunojejunal bypass, Weight loss, Complication, SG-uncut JJB

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chaoyang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SG-uncut JJB

SG-JJB

Arm 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.

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.

Outcomes

Primary Outcome Measures

excessive weight loss
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%.
total weight loss
total weight loss compared with preoperative weight

Secondary Outcome Measures

Complications
Complications within 30 days postoperatively
operating time
time from opeing of the operation to the end of the operation
intraoperative blood loss
blood loss during the operation

Full Information

First Posted
August 27, 2020
Last Updated
August 27, 2020
Sponsor
Zhen Jun Wang
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1. Study Identification

Unique Protocol Identification Number
NCT04534504
Brief Title
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients
Official Title
Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients, a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhen Jun Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Weight Loss, Total Weight Loss, Sleeve Gastrectomy, Jejunojejunal Bypass, Uncut
Keywords
sleeve gastrectomy, Jejunojejunal bypass, Weight loss, Complication, SG-uncut JJB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SG-uncut JJB
Arm Type
Experimental
Arm 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.
Arm Title
SG-JJB
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
SG-JJB
Intervention 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.
Primary Outcome Measure Information:
Title
excessive weight loss
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%.
Time Frame
1 year postoperatively
Title
total weight loss
Description
total weight loss compared with preoperative weight
Time Frame
1 year postoperatively
Secondary Outcome Measure Information:
Title
Complications
Description
Complications within 30 days postoperatively
Time Frame
30 days postoperatively
Title
operating time
Description
time from opeing of the operation to the end of the operation
Time Frame
during the operation
Title
intraoperative blood loss
Description
blood loss during the operation
Time Frame
during the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Gang Han
Phone
86-10-85231604
Email
hanjiagang@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Wei Zhai
Phone
86-10-85231328
Email
913916215@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Jun Wang
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
Phone
8613522867841
Email
hjg211@163.com
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
First Name & Middle Initial & Last Name & Degree
Zhenjun Wang, professor
First Name & Middle Initial & Last Name & Degree
Guanghui WEI, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients

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