Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass

Completed

• Conditions: Surgery; Diabetes
• Interventions: Procedure: Mini-Gastric Bypass Original Technique

• Registration Number: NCT04442698
• Lead Sponsor: Kular Hospital

Brief Summary

Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Detailed Description

There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Last Update Submitted: 2020-06-19
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Mini-Gastric Bypass -Original Technique post operative patients

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic MGB post op patients	Mini-Gastric Bypass Original Technique	Diabetic MGB post op patients

Primary Outcome Measures

Name	Time	Method
Delta Hemoglobin A1c Levels (HbA1c)	10 years	Delta HbA1c from Before to After MGB-OT surgery
Hemoglobin A1c Levels (HbA1c)	10 years	HbA1c Levels

Trial Locations

Locations (1)

Kular Hospital; 🇮🇳 Khanna, Punjab, India