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

Sleeve Gastrectomy Clinical Trial

Official title:

Sleeve Gastrectomy With Uncut Jejunal Bypass (SG-uncut JJB) Verus Sleeve Gastrectomy in Obese Patients, a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534504
• Other study ID #: SG-uncut JJB 01
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2020
• Source: Beijing Chao Yang Hospital
• Contact: Jia Gang Han
• Phone: 86-10-85231604
• Email: hanjiagang[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Excessive Weight Loss
• Jejunojejunal Bypass
• Sleeve Gastrectomy
• Total Weight Loss
• Uncut
• Weight Loss

Intervention

Procedure:
• SG-JJB
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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhen Jun Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	1 year postoperatively
Primary	total weight loss	total weight loss compared with preoperative weight	1 year postoperatively
Secondary	Complications	Complications within 30 days postoperatively	30 days postoperatively
Secondary	operating time	time from opeing of the operation to the end of the operation	during the operation
Secondary	intraoperative blood loss	blood loss during the operation	during the operation