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

NCT03859596 | Completed

• 1 other identifier: 0000
• Study Type: observational
• Target: 925
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Revisions After MGB/OAGB; Morbidities; Morality

Outcome Measures

Primary Outcomes (1)

• Morbidities assessed by liver failure, protien malnutrition, diarrhea , bleeding, afferent loop syndrome,stomal ulcer,perforation, leak,infection

  Liver failure, protien malnutrition, diarrhea , bleeding, afferent loop syndrome, stomal ulcer perforation,leak,infection.

  3 years

Secondary Outcomes (1)

• Mortality

  3 years

Study Arms (1)

MGB/OAGB

Consequent group of patients who underwent MGB/OAGB

Procedure: MGB/OAGB

Interventions

MGB/OAGB PROCEDURE

BARIATRIC PROCEDURE INVOLVED CREATION OF SLENDER GASTRIC POUCH OF 12-15CM IN LENGTH AND BILIO-PANCREATIC LIMB OF 150-200 CM

MGB/OAGB

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consequent series of obese patients with BMI more than 35 for English patients and more than 30 for Asians with comorbidities

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.
• Age 18-71 years -

You may not qualify if:

• Less than 18 or more than 71 years of age
• Not fit for bariatric surgery
• Psychiatric illness -

Sponsors & Collaborators

• ABDULZAHRA HUSSAIN: lead
• Phoenix Healthcare Group: collaborator
• Heart of England NHS Trust: collaborator
• The Whittington Hospital NHS Trust: collaborator
• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: collaborator
• Spire, Inc.: collaborator
• King's College Hospital NHS Trust: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: January 1, 2010
• Primary Completion: May 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02