| CTRI Number |
CTRI/2025/03/081535 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Compare between two surgical procedures] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the impact of two different surgical procedures (sleeve gastrectomy and single anastomosis sleeve jejunal bypass) on nutritional deficiency in patients with obesity |
|
Scientific Title of Study
|
The Effect of Single Anastomosis Sleeve Jejunal Bypass versus Sleeve Gastrectomy on Nutritional Deficiency following Bariatric Surgery: An exploratory 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 India Institute 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 Aakarsh Jain |
| 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 India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9717569770 |
| Fax |
|
| Email |
aakarsh0428@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakarsh Jain |
| 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 India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9717569770 |
| Fax |
|
| Email |
aakarsh0428@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 Aakarsh Jain |
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 |
9717569770
aakarsh0428@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 |
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 to 250-cm segment of jejunum distal to DJ-flexure will be connected to the pre-pyloric part of the sleeve gastrectomy |
| Comparator Agent |
group B: SG |
Sleeve Gastrectomy means about 80% of the stomach is removed leaving a sleeve of stomach (J shaped stomach-tube is created using surgical stapler over 38 F bougie). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI more than 32.5 with and without comorbidities
2. Asian population
|
|
| ExclusionCriteria |
| Details |
1. Biopsy proven Chronic liver disease
2. Revision bariatric surgery
3. Pregnancy, lactating mother
4. Failure to comply with the post-operative protocol (dietary advises and exercise etc.)
5. Pituitary tumors or adrenal tumors
6. 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 |
| To compare the nutritional deficiency between two bariatric bypass surgery |
6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Compare the % Excess Weight Loss between the two groups
2. Complications following surgery: Bleeding, Anastomotic leak, GERD, Vomiting, Marginal ulcer, DVT, and SSI
|
1. 1 year
2. 3 months following the date of the surgery |
|
|
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)
|
17/03/2025 |
| 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. According to ICMR-INDIAB study 2015.
5% of Indian population is obese; that is about 8 crore population is suffering
from obesity.
2. Bariatric procedures have started to
gain popularity in India. A total of 20,242 procedures were performed in 2018
which was a rise of approximately 86% from 2014.
3. There is an on-going debate between
different bariatric procedures (SG, MGB and Roux-en-Y and sleeve plus) on their
efficacy (adequate weight loss, remission of comorbidities and least
nutritional deficiency). Existing literature suggests that all bariatric
surgical procedures are compliance dependent (diet, exercise etc.), and the most
commonly performed bariatric surgery in India and the world is Sleeve
Gastrectomy. However, the weight regain and return of comorbidities was more
with SG than with the bypass procedures.
4. The bypass (Roux-en-Y and MGB)
procedures showed consistent weight loss and remission of co-morbidities
following bypass procedures on long term (7 to 10 year) follow up. However,
patients have higher rates of nutritional deficiencies (macro and
micronutrient) when compared to SG. Therefore, a few surgeons came out with
sleeve plus (SASI, SADI, etc) procedures so as to match efficacy to bypass
procedure and nutritional status to SG procedures.
5. A recent modification referred to as
single anastomosis sleeve jejunal (SAS-J) bypass is a transit bipartition
procedure which has benefits of sleeve and Roux-en-Y and MGB bypass and
diminished effects on nutritional deficiency. Literature review showed that
SAS-J bypass has better weight loss outcome than sleeve gastrectomy and better
nutritional status better than roux en Y bypass possibly.
6. From the available literature, there
have been no reports of suspected, unexpected, or serious complications
following SAS-J. Meanwhile, Sleeve bypass have been used as re-do procedures
following SG for weight regain.
7. There is no study in literature
comparing SASJ vs SG with nutritional status as the primary outcome.
8. The study by Huang C et al showed
that sleeve plus (SASI, SADI and LDJB + SG) had significant better weight loss
when compared to SG, MGB and Roux-en-Y; however, they had significant
nutritional deficiency.
9. There are a few articles on SAS-J
published in medical journals with good short term results. In a
study published by Sewefy A. et al in 2021 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.
10. There is no study in the English
literature comparing the two treatment protocol [SAS-J versus SG] in patients
with obesity with nutritional deficiency as primary outcome. Hence, this study
is proposed
|