Clinical trial NCT04930029: Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Official title: Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bypass Complication
Obesity
Keywords: One anastomosis gastric bypass
obesity
bariatric surgery
GERD
long term
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves patients:

* operated between 2008 and 2013 for an OAGB with a 150 or 200cm biliary limb
* fulfilling the HAS criteria(HAS, 2009) at the time of their surgery: BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with a comorbidity likely to be improved by weight loss
* benefiting from a follow-up.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of serious surgery-related adverse events
timeFrame: 10 years after surgery
Secondary outcomes:
measure: incidence of serious adverse events not related to surgery
timeFrame: 10 years after surgery
measure: Nutritional biological status , assessed by evaluation of malnutrition parameters
timeFrame: 10 years after surgery
measure: Nutritional clinical status, assessed by dietitian evaluation
timeFrame: 10 years after surgery
measure: Excess weight loss percentage
timeFrame: 10 years after surgery
measure: Metabolic comorbidities remission
timeFrame: 10 years after surgery
measure: Diabetes remission
timeFrame: 10 years after surgery
measure: Hypertension remission
timeFrame: 10 years after surgery
measure: Obstructive sleep apnea remission
timeFrame: 10 years after surgery
measure: Dyslipidemia remission
timeFrame: 10 years after surgery
measure: Quality of life by BAROS score (Bariatric analysis and reporting outcome system)
timeFrame: 10 years after surgery
measure: Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires
timeFrame: 10 years after surgery
measure: GERD
timeFrame: 10 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Robert CAIAZZO, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: