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CTRI Number  CTRI/2024/03/063944 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of Various Bariatric surgery procedures  
Scientific Title of Study   A Prospective Study Comparing the Outcomes of Mini-Gastric Bypass and Duodenojejunal Bypass in Morbidly Obese Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Ayushya Gupta 
Designation  JUNIOR RESIDENT  
Affiliation  GSVM MEDICAL COLLEGE, KANPUR  
Address  Room No.1, DEPARTMENT OF SURGERY, Lala Lajpat Rai Hospital (Hallett Hospital), GSVM MEDICAL COLLEGE, Kanpur Nagar, Uttar Pradesh

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  7080777553  
Fax    
Email  ayushyagupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SANJAY KALA 
Designation  PRINCIPAL AND PROFESSOR  
Affiliation  GSVM MEDICAL COLLEGE, KANPUR  
Address  PRINCIPAL OFFICE, GSVM MEDICAL COLLEGE, Kanpur Nagar, Uttar Pradesh

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  9839210012  
Fax    
Email  dr_sanjay_kala@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. Ayushya Gupta 
Designation  JUNIOR RESIDENT  
Affiliation  GSVM MEDICAL COLLEGE, KANPUR  
Address  Room No 1, Department of Surgery, Lala Lajpat Rai Hospital (Hallett Hospital) Sarvodaya Nagar, Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  7080777553  
Fax    
Email  ayushyagupta@gmail.com  
 
Source of Monetary or Material Support  
G.S.V.M. Medical College, Kanpur  
 
Primary Sponsor  
Name  Ayushya Gupta  
Address  Ayushman Laparoscopic Hospital and Maternity Center, Near Anta Chauraha, Shajahanpur, Uttar Pradesh  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Surgery   Department of Surgery, GSVM MEDICAL COLLEGE, KANPUR  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ayushya Gupta  Lala Lajpat Rai Hospital  Room no.1, Department of Surgery, G.S.V.M. Medical College, Sarvodaya Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 7080777553

ayushyagupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE GSVM MEDICAL COLLEGE KANPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DUODENOJEJUNAL BYPASS WITH SLEEVE GASTRECTOMY   The patient was placed in the gynecological position under general anesthesia. Five ports were used during the operation (Figure 1). Supraumblical port was used for laparoscope while 5 mm-port in subxiphoid area was used for liver retraction. Two 12 mm-ports were placed in the left subcostal margin and 10 cm caudal side. 15 mm-port was placed in the right upper quadrant. Sleeve gastrectomy was performed with 45 F boogie with linear stapler starting about 5 cm to prepyloric region. During the operation, biological materials could be used for stapler-line reinforcement or sleeve-line could be sutured. The posterior wall of the duodenum was carefully dissected and the first part of the duodenum was devascularized. Duodenum was divided with a blue cartridge of linear stapler with an absorbable buttress material. Biliopancreatic limb was measured 50–100 cm from the ligament of Treitz and divided by a white cartridge. The alimentary tract was also measured 150 cm (Figure 1). Jejunojejunostomy was performed with a white cartridge and the entry hole was closed by handsuturing. Mesenteric defect was closed by suturing. Omentum majus was divided to prevent the tension of anastomosis. Duodenojejunal end-to- side bypass was performed on two planes with 2/0 PDS absorbable suture for antecolic reconstruction. After checking for leakage, the operation was finalized with the insertion of drain. 
Intervention  MINI GASTRIC BYPASS  The operation is performed with the patient in the supine position with legs open and with 45 degrees inclined position. The operation begins with the dissection of the esophagogastric angle and the opening of the left gastrophrenic ligament with a harmonic scalpel, so as to expose the lateral aspect of the left diaphragmatic crus. Then, the ressection of the fat pad of the esophagogastric junction (Belsey’s fat) is performed. Then, the surgeon proceeds the ligation of the distal lesser sac, next to the insertion of the Latarjet nerve, using a harmonic scalpel until the exposure of the posterior gastric wall. The gastric pouch must be lengthy and narrow, measuring around 15-18 cm, with a 50-150 ml reservoir capacity. The pouch is created using 01 unit of 45mm blue cartridges to perform the horizontal section and 02 to 03 units to perform the vertical section. The stapling lines of the pouch and excluded stomach are then reinforced with a 3-0 polydioxanone continuous suture. The Treitz ligament is then identified and the small bowel is counted until 200 cm from the Treitz angle, determining the exclusion of part of the stomach, duodenum, and proximal jejunum from the food pathway. This segment is then attached to the pouch and a vertical or slightly oblique omega-loop, isoperistaltic, antecolic, and side-to-side 25mm-gastrojejunostomy is performed using a 45mm white cartridge; the orifice for the cartridge insertion is closed by means of a continuous suture with 3-0 polydioxanone reinforced with separate stitches of 3-0 polyester. The attachment of the patient to the surgical table is made by placing two belts (on the abdominal area and below the level of the thighs, respectively). The surgeon stands between the legs, with the 1st assistant, who handles the camera and the auxiliary clamp, and the scrub on the right. Urinary bladder catheterization is not used. Antibiotic prophylaxis were routinely administered. The prevention of thrombotic events is made with use of graduated compression stockings and intermittent pneumatic boots. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  BMI more than 37.5kg/m2 or BMI more than 32.5kg/m2 with associated co-morbidities (hypertension, diabetes mellitus, OSA)
Patient who are willing to give complete written informed consent form acknowledging procedure and risks, awareness of the alternative treatments, risks involved .
Ability to return for scheduled follow up examinations for 3 years after bariatric surgery. 
 
ExclusionCriteria 
Details  Age less than 18 years.
Lack of informed consent.
Inability to ambulate .
Deep vein thrombosis .
General poor health .
In women with pregnancy or nursing or plans to become pregnant at same time during the course of treatment .
Addiction to smoking, alcohol or substance abuse.
Uncontrolled severe psychiatric illness
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Weight Loss   Baseline, 3, 6 and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Resolution of DM   Baseline, 3, 6 and 12 months  
Resolution of Hypertension   Baseline, 3, 6 and 12 months  
Resolution of Dyslipidemia  Baseline, 3, 6 and 12 months  
 
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 4 
Date of First Enrollment (India)   15/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayushyagupta@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study aims to study and compare the efficacy in terms of weight loss and resolution of comorbidities of two bariatric surgery procedures namely Mini Gastric Bypass and Duodenojejunal Bypass in the North Indian population. This will help establish the efficacy of these procedures in North Indian population and guide surgeons in selecting procedure tailored for various comorbidities.

Primary Objective
To determine extent of weight loss in MGB and DJB in morbidly obese patients. 

Secondary Objectives:
To determine resolution of type 2 DM, hypertension and dyslipidemia in 1 year follow up.
To determine patient mortality in 1 year follow up period.
To evaluate various complications of both the techniques in 1 year follow up.
To evaluate cost effectiveness of various techniques.

Criteria for resolution of comorbidities -
Hypertension - 
complete resolution - normal recorded blood pressure without use of antihypertensive drugs
Partial resolution - decrease in BP from the baseline preoperative level but not to normal levels 
2. Diabetes mellitus -
complete remission - normal recorded HBA1C levels without use of anti-diabetic medications
Partial resolution - Decrease in HBA1C but not to normal levels.
3. Dyslipidemia -
Resolution - normal recorded serum cholesterol levels.
no resolution - abnormal levels of serum cholesterol.

STATISTICAL ANALYSIS – Statistical analysis will be performed using statistical package for the social sciences (SPSS) version 21.0. For all analyses, P value less than 0.05 will be considered statistically significant.
 
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