NCT03859596

Revisional Surgery After 925 OAGB[One Anastomosis Gastric Bypass] Operations Retrospective Cohort Study of the UK MGB/OAGB Collaborative Group.

Completed Last updated 1 March 2019

What this trial tests

trial testing MGB/OAGB in Revisions After MGB/OAGB in 925 participants. Completed in 1 January 2019.

Timeline

1 January 2010

Primary endpoint
1 May 2018

1 January 2019

Quick facts

Lead sponsor	ABDULZAHRA HUSSAIN
Status	Completed
Study type	OBSERVATIONAL
Enrollment	925
Start date	1 January 2010
Primary completion	1 May 2018
Estimated completion	1 January 2019

Drugs / interventions tested

• MGB/OAGB

Conditions studied

• Revisions After MGB/OAGB — all drugs for Revisions After MGB/OAGB →
• Morbidities — all drugs for Morbidities →
• Morality — all drugs for Morality →

Sponsor

ABDULZAHRA HUSSAIN

Who can join

Adults 18 to 71, any sex, with Revisions After MGB/OAGB or Morbidities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is a new operation that provides comparable outcomes to the common bariatric procedures. Revisional surgery is still needed after a number of OAGB/MGB procedures. The aim of this study is to report the causes and management of these revisions.

Methods: From 2010 -2018, 925 OAGB/MGB operations were performed at 7 bariatric units across the United Kingdom and included in this retrospective cohort study. The data was retrospectively collected and analysed. The primary end point was identification of the causes and management of revisions. Follow up ranged from 6 months to 3 years.

Results: Twenty-two patients (2.3%) required revisional surgery after OAGB/MGB. Five patients (0.5%) developed severe diarrhoea managed by shortening the bilio-pancreatic limb (BPL) to 150cm. Four patients (0.4%) developed afferent loop syndrome and bile reflux was reported in another 3 (0.3%) cases; all were managed by either conversion to Roux en Y Gastric Bypass (RYGB) or a Braun anastomosis. Postoperative bleeding was controlled laparoscopically in 3 patients (0.3%). Liver decompensation was reported in 2 patients (0.2%) was treated by shortening the BPL in one patient and a reversal to normal anatomy in another. The liver failure resolved in both patients. Other indications for revision included two gastro-jejunal stenosis (0.2%), one perforated ulcer (0.1%), one patient (0.1%) with excessive weight loss and one case (0.1%) of protein malnutrition. None of the 22 patients undergoing revisional surgery after OAGB/MBG died. Lost to follow up rate was 0.2%.

Conclusion: Complications requiring revisional surgery after OAGB/MGB are uncommon (2.3%) and the majority can be managed by bilio-pancreatic limb shortening, the addition of a Braun side-to-side anastomosis or conversion to RYGB. Bilio-pancreatic limb length of 200 cm or more resulted in serious complications of liver failure, protein malnutrition, excessive weight loss and diarrhoea.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.