Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-12 @ 7:01 AM
Study NCT ID:
NCT03673969
Status:
WITHDRAWN
Last Update Posted:
2019-07-26
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mini Gastric Bypass vs Roux enY Gastric Bypass
Sponsor:
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Mini Gastric Bypass vs Roux enY Gastric Bypass
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding to progress the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MGB vs RYGB
Brief Summary:
The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK
Detailed Description:
The main aim of this project is to develop an ideal bariatric/metabolic surgery operation.
The ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients.
Mini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK.
No previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.
The ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients.
Mini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK.
No previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: