CClinicalTrials.gg
CompletedNCT04440306BplVsWtLossUpdated Jun 19, 2020

"Tailored" Bilio-Pancreatic Limb Length and Weight Loss After Mini-Gastric Bypass

An observational study in Obesity, Morbid, Weight Loss and Bariatric Surgery Candidate, sponsored by Kular Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-19.

Sponsored by Kular Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
191
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Retrospective review of prospectively collected blinded patient data. To Address simple question:

In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10 years following operation.

Read the detailed description

Methods:

The investigators performed a review of a prospectively collected database system of patients undergoing tailored MGB-OT at Kular hospital, Punjab, India. Patients who underwent tailored MGB-OT between June 2008 and December 2009 were included. Primary outcomes of interest included a variety of weight loss outcome measures including % Excess Weight Loss (%EWL) at 1, 5 and 10 years in relation to a "tailored" Bilio-Pancreatic Limb Length (BPLL.)

The study was motivated by questions raised suggesting that a BPLL in the OAGB (MGB-OT) should be limited to 150 cm. Data were collected with a team of nurses and support staff that maintained a daily calling and follow up list adding data to an easily accessible online electronic database.

The analytic process assessed various weight loss outcomes at 1, 5 and 10 years following "tailored" BPLLs in patients undergoing the Mini-Gastric Bypass Original Technique (MGB-OT) as described by Rutledge. In addition to using simple statistical methods to assess the relation of the BPLLs to weight loss outcomes, a linear regression model was used to analyse and quantify the relationship between the length of the tailored BP limb and the weight loss measures a 1, 5 and 10 years after operation.

The study design focused upon the "power" of the BPLL as measured by 1, 5 and 10 year weight loss outcomes. The study was designed to answer two specific questions: first is a "FIXED" BPLL of 150 cm best for everyone (I.e. like the fixed BPLL used in the RNY) or put differently: is a 150 cm BPLL equally efficacious as compared to a longer BPLL when judged by measures of weight loss at 1, 5 and 10 years after surgery. Analysis included comparing BPLLs to the various 1, 5 and 10 year weight loss measures such as BMI, %BMI lost, Total weight at 10 years, % Excess Weight Loss at 10 yrs and other standard outcome measures.

Further, if such a relationship does indeed exist, can it be more precisely quantified? For example, is it "linear," that is to say for each and every additional cm of BPLL do the various long term weight loss measures increase similarly?.

There are of course many other questions now in bariatric surgery and related to the MGB/OAGB but the present study was designed to be sharply focused upon these two questions. Risk benefit and predictive power and multivariate analysis and creation of guidelines are in process and have been addressed in the past and will be part of subsequent publications., , ,

Notably the government of India health-care system provides no support for bariatric surgery and specifically no support at all for the MGB at any time during the course of this study and up until the time of this writing. All patients in the study paid out of pocket for the operation. The self pay situation and the fact that poor outcomes are little tolerated are also worthwhile noting. Given this climate and the capped hospital resources in a small town, it has been remarkable that the surgeons in this study have maintained a sterling record of excellent outcomes, a busy clinical practice with outcomes and results that rival those reported from other areas of the world including some of the best hospitals in the United States. The "tailored" MGB-OT used by the surgeon authors facilitated excellent outcomes and supported their success even in such demanding circumstances.

Once a significant association between BPLL and outcomes was determined, then a linear regression analysis was performed to further quantitate and describe the relationship between BPLL and outcome measures.

The present small first step is part of a longer term effort to investigate creation of a tool so robust that it might act as a guide for both patients and surgeons who might select the MGB-OT.

The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical permission was obtained from the local ethics committee and all participants provided written informed consent for data sharing.

02

Conditions studied

  • Obesity, Morbid
  • Weight Loss
  • Bariatric Surgery Candidate
  • Power

Keywords

  • Mini-Gastric Bypass
  • Bilio-Pancreatic Limb Length
  • Weight loss
  • One Anastomosis Gastric Bypass
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 191 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Kular Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients selected for Mini-Gastric Bypass - Original Technique at Kular Hospital

Eligibility criteria

Inclusion Criteria: Patients selected for Mini-Gastric Bypass - Original Technique at Kular Hospital -

Exclusion Criteria: None

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
191 participants (actual)
Patient registry
No

Interventions

  • ProcedureMini-Gastric Bypass - Original Technique

    Mini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL

    Also known as: Tailored Bilio-Pancreatic Limb Length

06

What researchers measure

Primary outcomes

  1. Percent Excess Weight Loss

    Amount of weight lost assessed by Percent Excess Weight Loss

    Time frame: 10 years following operation

  2. Percent Total Weight Loss

    Amount of weight lost assessed by Percent of Total Weight Loss

    Time frame: 10 years following operation

07

Study locations

1 site
  • Kular Hospital
    Khanna, Punjab 141412, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04440306
Lead sponsor
Kular Hospital
Responsible party
Dr. Robert Rutledge (Research Director, Kular Hospital) — Principal investigator
First posted
Jun 19, 2020
Start date
Jan 1, 2018
Primary completion
Jan 1, 2020
Completion
Feb 1, 2020
Last update
Jun 19, 2020

Study contacts

R Rutledge, MD
principal investigator · Kular Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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