Clinical trial NCT04534504: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Excessive Weight Loss
Total Weight Loss
Sleeve Gastrectomy
Jejunojejunal Bypass
Uncut
Keywords: sleeve gastrectomy
Jejunojejunal bypass
Weight loss
Complication
SG-uncut JJB
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: excessive weight loss
timeFrame: 1 year postoperatively
measure: total weight loss
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Complications
timeFrame: 30 days postoperatively
measure: operating time
timeFrame: during the operation
measure: intraoperative blood loss
timeFrame: during the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zhen Jun Wang
role: STUDY_CHAIR
References: