Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega (OMEGA10)
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).
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Robert CAIAZZO, MD,PhD
- 電話番号：+33 0320445962
- メール：robert.caiazzo@chru-lille.fr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
OAGB150
One anastomosis gastric bypass with 150cm biliary limb
|
Clinical, biological and endoscopic evaluation
|
|
OAGB200
One anastomosis gastric bypass with 200cm biliary limb
|
Clinical, biological and endoscopic evaluation
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of serious surgery-related adverse events
時間枠：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.
|
10 years after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
incidence of serious adverse events not related to surgery
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Nutritional biological status , assessed by evaluation of malnutrition parameters
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Nutritional clinical status, assessed by dietitian evaluation
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Excess weight loss percentage
時間枠：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.
|
10 years after surgery
|
|
Metabolic comorbidities remission
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Diabetes remission
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Hypertension remission
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Obstructive sleep apnea remission
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Dyslipidemia remission
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)
時間枠：10 years after surgery
|
10 years after surgery
|
|
|
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires
時間枠：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).
|
10 years after surgery
|
|
GERD
時間枠：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
|
10 years after surgery
|
協力者と研究者
捜査官
- 主任研究者：Robert CAIAZZO, MD,PhD、University Hospital, Lille
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Ten year evaluationの臨床試験
-
MedtronicNeuro完了
-
Thync Global, Inc.ethica Clinical Research Inc.完了
-
Memorial Sloan Kettering Cancer CenterComprehensive Cancer Centre The Netherlands募集