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NCT Number: NCT04442139

Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Daily Food Choices in Mini-Gastric Bypass

Bariatric surgery (BS) has a history of new procedures and techniques arising and then disappearing due to problems and complications. The present is no different with new and old procedures changing with the regularity of night following day.

One of the important questions today in BS is the length and or need/value of the Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have "0" bypass, the RNY has a "short" bypass and the Biliopancreatic Diversion type procedures have a "long" (distal) bypass.

The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) includes a "medium" length of bypass, longer than the BPLL of the RNY and shorter than the the "Long" BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a "Tailored" BPLL.

Not all OAGB surgeons use this approach and several have argued in favor of a "Fixed" BPLL of 150 cm.

This paper is part of a series of studies of the "Tailored" BPLL specifically in MGB-OT patients.

Notably it demonstrates in an online survey that patient reported weight loss and food choices change after MGB-OT and in addition the changes are related to the "Tailored" BPLL

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Key information

Conditions

Obesity Bariatric Surgery Candidate Behavior Behavior, Animal Body Weight Diet Habit Feeding Behavior Food Preferences Food Selection Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kular Hospital

Khanna, Punjab, 141412, India

About this study

Introduction:

Studies of different Bariatric procedures have resulted in conflicting findings on the effects of the surgery on daily Dietary Food Choices (DFCs.) Some suggest a pure volume effect, others report changes in type and preferences and still others suggest the effects change over time. The Biliopancreatic Limb Length (BPLL) in the One Anastomosis Gastric Bypass (OAGB), Mini-Gastric Bypass-Original Technique (MGB-OT) version, includes a "tailored" BPLL. The purpose of this study was to investigate the relationship between BPLL and DFCs in patients undergoing MGB-OT. The primary hypothesis was that the changes in dietary habits and food choices would be related to the BPLL in the MGB-OT.

Methods:

Data from a long term online patient survey including MGB-OT patients were collected including basic demographics, MGB-OT BPLL, patient reported DFCs and weight loss classes. Linear regression modeling was used to assess the relative association between BPLL with various mean patient reported DFCs and a composite model of Food Choices.

Results:

Patients survey responses to be evaluated. Patients with reported BPLLs of 3 to 9 ft (92-274cm) will be selected. Patient reported mean weight loss classes to be evaluated. The linear relation to BPLL to be evaluated. The mean "Bad" Food Choices (BFC) to be determined.

Conclusions:

The present study of mean patient reported DFC outcomes following a "Tailored" BPLL in the MGB-OT version of the OAGB to be evaluated. The patient dietary food choices for fried foods, sugar sweetened beverages, processed meats and junk foods all to be determined. These changes linear regression to the Bilio-pancreatic limb length to be determined. In cases of the MGB-OT a longer Bilio-pancreatic Limb Length association with greater weight loss and a greater improvement in daily Dietary Food Choices would be major importance. The possibility of tailoring the power of a bariatric operation based upon BPLL might well be an important advancement in bariatric surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post Mini-Gastric Bypass Patients

Exclusion criteria

-

Treatment and study plan

Mini-Gastric Bypass

Other

Mini-Gastric Bypass bariatric surgery

Primary outcomes

  1. Food Choices

    Time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass

    Patient Reported Food choices

Other outcomes

  1. Weight Loss

    Time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass

    Pre and post reported weights and amount of reported weight loss

Sponsors and collaborators

Lead sponsor

Kular Hospital

Other

Registry information

Official study title

Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Mean Weight Loss and Mean Daily Dietary Food Choices in the One Anastomosis Gastric Bypass (Mini-Gastric Bypass-Original Technique)

Acronym: TaBLFood-MGB

Important dates

Study start
2008
Primary completion
2019
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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