Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

Obesity Clinical Trial

— OMEGA10  

Official title:

Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04930029
• Other study ID #: 2020_82
• Secondary ID: 2020-A03156-33
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Robert CAIAZZO, MD,PhD
• Phone: 0320445962
• Email: robert.caiazzo[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bypass Complication
• Long Term Adverse Effects
• Obesity

Intervention

Other:
• Ten year evaluation
Clinical, biological and endoscopic evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious surgery-related adverse events	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.	10 years after surgery
Secondary	incidence of serious adverse events not related to surgery		10 years after surgery
Secondary	Nutritional biological status , assessed by evaluation of malnutrition parameters		10 years after surgery
Secondary	Nutritional clinical status, assessed by dietitian evaluation		10 years after surgery
Secondary	Excess weight loss percentage	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.	10 years after surgery
Secondary	Metabolic comorbidities remission		10 years after surgery
Secondary	Diabetes remission		10 years after surgery
Secondary	Hypertension remission		10 years after surgery
Secondary	Obstructive sleep apnea remission		10 years after surgery
Secondary	Dyslipidemia remission		10 years after surgery
Secondary	Quality of life by BAROS score (Bariatric analysis and reporting outcome system)		10 years after surgery
Secondary	Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires	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).	10 years after surgery
Secondary	GERD	GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia	10 years after surgery