Bypass Complication, Obesity
Conditions
Keywords
One anastomosis gastric bypass, obesity, bariatric surgery, GERD, long term
Brief summary
The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted. The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).
Interventions
OTHERTen year evaluation
Clinical, biological and endoscopic evaluation
Sponsors
University Hospital, Lille
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center. * Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center. * Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years * Patients who gave their consent * Patients with health insurance coverage
Exclusion criteria
* Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009) * Persons deprived of liberty, under guardianship, or under curatorship * Patients included in a protocol with a conflict of interest with OMEGA10.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious surgery-related adverse events | 10 years after surgery | A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The surgery-related character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional biological status , assessed by evaluation of malnutrition parameters | 10 years after surgery | — |
| Nutritional clinical status, assessed by dietitian evaluation | 10 years after surgery | — |
| Excess weight loss percentage | 10 years after surgery | calculated as follows: (weight at 10 years - initial weight) / (initial weight - ideal weight) x 100 The ideal weight is defined as the weight corresponding to a BMI = 25 kg/m2. The initial weight is the weight on the day of surgery. |
| Metabolic comorbidities remission | 10 years after surgery | — |
| Diabetes remission | 10 years after surgery | — |
| incidence of serious adverse events not related to surgery | 10 years after surgery | — |
| Obstructive sleep apnea remission | 10 years after surgery | — |
| Dyslipidemia remission | 10 years after surgery | — |
| Quality of life by BAROS score (Bariatric analysis and reporting outcome system) | 10 years after surgery | — |
| Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires | 10 years after surgery | The GIQLI is a score to evaluate digestive disorders in 36 items, ranging from 0 (the worst quality of life) to 144 (the best quality of life). |
| GERD | 10 years after surgery | GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia |
| Hypertension remission | 10 years after surgery | — |
Countries
France
Contacts
Primary ContactRobert CAIAZZO, MD,PhD
Outcome results
None listed