Morality Clinical Trial
Official title:
Revisional Surgery After 925 OAGB Operations Retrospective Cohort Study of the United Kingdom MGB[Mini Gastric Bypass]/OAGB Collaborative Group.
NCT number | NCT03859596 |
Other study ID # | 0000 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2010 |
Est. completion date | January 1, 2019 |
Verified date | February 2019 |
Source | ParkHill Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 925 |
Est. completion date | January 1, 2019 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 71 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss. 3. The person has been receiving or will receive intensive management in a tier 3 service. 4. The person is generally fit for anaesthesia and surgery. 5. The person commits to the need for long-term follow-up. 6. Age 18-71 years - Exclusion Criteria: 1. Less than 18 or more than 71 years of age 2. Not fit for bariatric surgery 3. Psychiatric illness - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ABDULZAHRA HUSSAIN | Doncaster And Bassetlaw Hospitals NHS Foundation Trust, Heart of England NHS Trust, King's College Hospital NHS Trust, Phoenix Healthcare Group, Spire, Inc., The Whittington Hospital NHS Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mortality | Death after revision | 3 years |
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