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

June 18, 2020 updated by: Dr. Robert Rutledge, Kular Hospital

"Tailored" Bilio-Pancreatic Limb Length and Weight Loss After One Anastomosis Gastric Bypass [" Mini-Gastric Bypass Original Technique"]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Khanna, Punjab, India, 141412
        • Kular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Exclusion Criteria: None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Excess Weight Loss
Time Frame: 10 years following operation
Amount of weight lost assessed by Percent Excess Weight Loss
10 years following operation
Percent Total Weight Loss
Time Frame: 10 years following operation
Amount of weight lost assessed by Percent of Total Weight Loss
10 years following operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kular Hospital

Investigators

  • Principal Investigator: R Rutledge, MD, Kular Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPLL-vs-WtLoss

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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