| CTRI Number |
CTRI/2025/04/084396 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Between two surgical procedures] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of variation in biliopancreatic bowel limb length between 200-cm and 250-cm on weight loss following one site stomach to jejunum joining in patients with obesity |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjunath Maruti Pol |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All IndiaInstitute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9990187137 |
| Fax |
|
| Email |
manjunath.pol@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angshuman Dutta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All IndiaInstitute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8486252608 |
| Fax |
|
| Email |
angshumandutta8820@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angshuman Dutta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All IndiaInstitute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8486252608 |
| Fax |
|
| Email |
angshumandutta8820@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines, fourth floor, Surgery Block, All India Institute ofMedical Sciences (AIIMS), Ansari Nagar, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Angshuman Dutta |
Surgery Block AIIMS Delhi |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All IndiaInstitute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI |
8486252608
angshumandutta8820@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: SAS-J 200cm BPLL |
Single Anastomosis Sleeve Jejunal Bypass; that is a segment of proximal jejunum is anastomosed to the pre-pyloric part of sleeve gastrectomy. About 5cm size anastomosis will be created, and about 200-cm segment of jejunum distal to DJ-flexure will be connected to the pre-pyloric part of the sleeve gastrectomy |
| Comparator Agent |
Group B: SAS-J 250cm BPLL |
Single Anastomosis Sleeve Jejunal Bypass; that is a segment of proximal jejunum is anastomosed to the pre-pyloric part of sleeve gastrectomy. About 5cm size anastomosis will be created, and about 250-cm segment of jejunum distal to DJ-flexure will be connected to the pre-pyloric part of the sleeve gastrectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI more than 27.5 with Diabetes Mellitus
2. BMI more than 32.5
3. Asian population
|
|
| ExclusionCriteria |
| Details |
1. Refusal to participate in the study
2. Biopsy proven Chronic liver disease
3. Protein loosing enteropathy
4. Revision bariatric surgery
5. Pregnancy, lactating mother
6. Failure to comply with the post-operative protocol (dietary advises and exercise etc.)
7. Pituitary tumors or adrenal tumors
8. Long term use of anti-depressants or immunosuppressant’s including corticosteroids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of SASJ between the two groups |
6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Remission of comorbidities: Diabetes mellitus (HBA1C), Hypertension, Dyslipidemia, Hypothyroidism, OSA, and Non Alcoholic Fatty liver, Gastro-esophageal reflux disease, and Albuminuria
2.Complications: Bleeding, Anastomotic leak, GERD, Vomiting, Marginal ulcer, DVT, and SSI
|
1. 6 months and 1 year
2. up to post-operative day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
- 8. 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.
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