NCT04440306

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 16, 2020

Last Update Submit

June 18, 2020

Conditions

Obesity, MorbidWeight LossBariatric Surgery CandidatePower

Keywords

Mini-Gastric BypassBilio-Pancreatic Limb LengthWeight lossOne Anastomosis Gastric Bypass

Outcome Measures

Primary Outcomes (2)

  • Percent Excess Weight Loss

    Amount of weight lost assessed by Percent Excess Weight Loss

    10 years following operation

  • Percent Total Weight Loss

    Amount of weight lost assessed by Percent of Total Weight Loss

    10 years following operation

Interventions

Mini-Gastric Bypass - Original TechniquePROCEDURE

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kular Hospital

Khanna, Punjab, 141412, India

Location

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • R Rutledge, MD

    Kular Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)