Mini Gastric Bypass vs Roux enY Gastric Bypass

NCT03673969 | Withdrawn

• 1 other identifier: 0945 2018 NCTS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK

Conditions

Gastric Bypass

Keywords

Mini Gastric Bypass; Roux En-Y Gastric Bypass; Bariatric surgery; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Excess weight loss

  Amount of weight lost

  2 years post surgery

Secondary Outcomes (12)

• Type 2 diabetes remission

  6 months, 2 years, 5 years and 10 years

• Morbidity

  6 months, 2 years, 5 years and 10 years

• Mortality

  6 months, 2 years, 5 years and 10 years

• Operative time

  6 months, 2 years, 5 years and 10 years

• Length of stay

  6 months, 2 years, 5 years and 10 years

Study Arms (2)

MGB

ACTIVE COMPARATOR

Mini gastric bypass

Procedure: Gastric bypass

Roux enY gastric bypass

ACTIVE COMPARATOR

Roux enY gastric bypass

Procedure: Gastric bypass

Interventions

Gastric bypass PROCEDURE

Surgical method of gastric bypass

MGB; Roux enY gastric bypass

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight.
• All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss.
• The person has been receiving or will receive intensive management in a tier 3 service.
• The person is generally fit for anaesthesia and surgery.
• The person commits to the need for long-term follow-up

You may not qualify if:

• Not meeting the eligibility criteria
• Under 18s

Sponsors & Collaborators

• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: lead

Study Sites (1)

Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not know the arm prior to surgery, but will be made aware of it afterward
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: February 1, 2019
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)