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出境医 / 临床实验 / Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega (OMEGA10)

Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega (OMEGA10)

Study Description
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).


Condition or disease Intervention/treatment
Bypass Complication Obesity Other: Ten year evaluation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
Group/Cohort Intervention/treatment
OAGB150
One anastomosis gastric bypass with 150cm biliary limb
 Other: Ten year evaluation
Clinical, biological and endoscopic evaluation
OAGB200
One anastomosis gastric bypass with 200cm biliary limb
 Other: Ten year evaluation
Clinical, biological and endoscopic evaluation
Outcome Measures
Primary Outcome Measures :
  1. Incidence of serious surgery-related adverse events [ Time Frame: 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 Outcome Measures :
  1. incidence of serious adverse events not related to surgery [ Time Frame: 10 years after surgery ]
  2. Nutritional biological status , assessed by evaluation of malnutrition parameters [ Time Frame: 10 years after surgery ]
  3. Nutritional clinical status, assessed by dietitian evaluation [ Time Frame: 10 years after surgery ]
  4. Excess weight loss percentage [ Time Frame: 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.

  5. Metabolic comorbidities remission [ Time Frame: 10 years after surgery ]
  6. Diabetes remission [ Time Frame: 10 years after surgery ]
  7. Hypertension remission [ Time Frame: 10 years after surgery ]
  8. Obstructive sleep apnea remission [ Time Frame: 10 years after surgery ]
  9. Dyslipidemia remission [ Time Frame: 10 years after surgery ]
  10. Quality of life by BAROS score (Bariatric analysis and reporting outcome system) [ Time Frame: 10 years after surgery ]
  11. Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires [ Time Frame: 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).

  12. GERD [ Time Frame: 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Robert CAIAZZO, MD,PhD 0320445962 ext +33 robert.caiazzo@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Robert CAIAZZO, MD,PhD University Hospital, Lille
Tracking Information
First Submitted Date June 10, 2021
First Posted Date June 18, 2021
Last Update Posted Date June 18, 2021
Estimated Study Start Date September 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2021) 		Incidence of serious surgery-related adverse events [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 10, 2021)
  • incidence of serious adverse events not related to surgery [ Time Frame: 10 years after surgery ]
  • Nutritional biological status , assessed by evaluation of malnutrition parameters [ Time Frame: 10 years after surgery ]
  • Nutritional clinical status, assessed by dietitian evaluation [ Time Frame: 10 years after surgery ]
  • Excess weight loss percentage [ Time Frame: 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 [ Time Frame: 10 years after surgery ]
  • Diabetes remission [ Time Frame: 10 years after surgery ]
  • Hypertension remission [ Time Frame: 10 years after surgery ]
  • Obstructive sleep apnea remission [ Time Frame: 10 years after surgery ]
  • Dyslipidemia remission [ Time Frame: 10 years after surgery ]
  • Quality of life by BAROS score (Bariatric analysis and reporting outcome system) [ Time Frame: 10 years after surgery ]
  • Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
Official Title Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Bypass Complication
  • Obesity
Intervention Other: Ten year evaluation
Clinical, biological and endoscopic evaluation
Study Groups/Cohorts
  • OAGB150
    One anastomosis gastric bypass with 150cm biliary limb
    Intervention: Other: Ten year evaluation
  • OAGB200
    One anastomosis gastric bypass with 200cm biliary limb
    Intervention: Other: Ten year evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 10, 2021) 		320
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Robert CAIAZZO, MD,PhD 0320445962 ext +33 robert.caiazzo@chru-lille.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04930029
Other Study ID Numbers 2020_82
2020-A03156-33 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Robert CAIAZZO, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date June 2021