CTRI/2025/04/084396RecruitingPhase 2
The Effect of 200-cm versus 250-cm Biliopancreatic Limb in Single Anastomosis Sleeve jejunal Bypass on weight loss following Bariatric Surgery: A PHASE II Randomized Controlled Trial
AIIMS NEW DELHI1 site in 1 country50 target enrollmentStarted: April 21, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Efficacy of SASJ between the two groups
Study Overview
Brief Summary
- 1. SASJ (Single anastomosis sleeve jejunal bypass) is a modification of Single anastomosis sleeve ileal (SASI) bypass surgery that has been used as re-do procedures for weight regain following SG.
- 2. SASJ has shown similar trends in resolution of outcomes when compared to RYGB (Roux-en-Y gastric bypass), MGB (mini-gastric bypass), SASI (single anastomosis sleeve ileal), BPD+DS (biliopancreatic diversion + duodenal switch) and SADI (single anastomosis duodeno-ileal). Our experience showed that SASJ is equally efficacious and technically feasible. From the available literature, there have been no reports of suspected, unexpected, or serious complications associated with SASJ bypass.
- 3. In a study published by Rezaei MT, et al. (Obes Surg. 2023), at the end of 18 months following SASJ bypass achieved satisfactory weight loss [BMI decreased from 44.9 ± 4.7 to 28.6 ± 3.8 kg/m2 : p < 0.001] and remissions in diabetes (100%) without major complications and malnutrition.
- 4. There is an on-going debate between different bariatric procedures (MGB and Roux-en-Y and sleeve plus) with variations in their BPLL on their efficacy (adequate weight loss, remission of comorbidities and least nutritional deficiency). Existing literature suggests that the average percentage of excess weight loss (%EWL) was highest for a MGB with BPLL of 180 cm, compared to 150 cm and 250 cm. However, nutritional deficiency was more pronounced at 250 cm. (Ahuja, A.et al. MGB-OAGB: Effect of Biliopancreatic Limb Length on Nutritional Deficiency, Weight Loss, and Comorbidity Resolution.)
- 5. Long BPLL (200-cm) RYGB patients experienced greater weight loss at 12 months (%EWL) compared to those with MGB with similar BPLL. However, the complications such as leak, internal hernia, nutritional deficiency, duration of surgery was higher in RYGB w.c.t MGB. (Zerrweck, C.et al, Long versus short biliopancreatic limb in Roux-en-Y gastric bypass)
- 6. In a study published by Sewefy AM, et al. Int J Surg. 2022 it was observed that SASJ procedure resulted in satisfactory weight loss and better nutritional status. However, it was a retrospective cohort study, heterogeneous groups (compared to MGB, Roux-en-Y and SG) with primary outcome as weight loss rather than nutritional deficiency. The authors in this study concluded that SAS-J, LSG, roux - en -Y and MGB and SADI had 85%, 59%, 56 – 72% and 60 – 84% and 91 -95% weight loss at 1 year
- 7. SASJ is a bipartisan and has shown lower nutritional deficiencies w.c.t MGB or Roux-en-y gastric bypass, and has the advantage of performing endoscopy when needed owing to retained duodenum.
-
- There is no study in literature comparing SASJ with two different BPLL and their effects on weight loss, comorbidities and nutritional in patients with obesity. Hence, this study is proposed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •BMI more than 27.5 with Diabetes Mellitus
- •BMI more than 32.5
- •Asian population.
Exclusion Criteria
- •Refusal to participate in the study
- •Protein loosing enteropathy
- •Revision bariatric surgery
- •Pregnancy, lactating mother
- •Failure to comply with the post-operative protocol (dietary advises and exercise etc.)
- •Pituitary tumors or adrenal tumors
- •Long term use of anti-depressants or immunosuppressant’s including corticosteroids.
Outcomes
Primary Outcomes
Efficacy of SASJ between the two groups
Time Frame: 6 and 12 months
Secondary Outcomes
- 1.Remission of comorbidities: Diabetes mellitus (HBA1C), Hypertension, Dyslipidemia, Hypothyroidism, OSA, and Non Alcoholic Fatty liver, Gastro-esophageal reflux disease, and Albuminuria
Investigators
Manjunath Maruti Pol
All India Institute of Medical Sciences New Delhi
Study Sites (1)
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