Extending and Banding the Roux-en-Y Gastric Bypass (UPGRADE)
調査の概要
詳細な説明
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Rijnstate Hazebroek
- 電話番号:+31880055970
- メール:info@vitalys.nl
研究場所
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Den Haag、オランダ
- まだ募集していません
- NOK West
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コンタクト:
- Liem
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Gelderland
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Arnhem、Gelderland、オランダ、6815AD
- 募集
- Rijnstate Hospital
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コンタクト:
- Hazebroek
- 電話番号:0880055970
- メール:info@vitalys.nl
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Utrecht
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Nieuwegein、Utrecht、オランダ、3435CM
- まだ募集していません
- St. Antonius Ziekenhuis
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コンタクト:
- Derksen
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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
説明
Inclusion Criteria:
- All patients who are eligible for a primary RYGB
Exclusion Criteria:
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
- Renal impairment (MDRD <30)
- Hepatic dysfunction (liver function twice the normal values)
- Pregnancy during follow-up
- Patients with treatment-resistant reflux symptoms.
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Standard RYGB
127 patients undergo a standard Roux-en-Y gastric bypass
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Roux-en-Y Gastric bypass
他の名前:
|
実験的:Extended Pouch RYGB
127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.
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Roux-en-Y gastric bypass with an extended pouch
他の名前:
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実験的:Banded Extended RYGB
127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.
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Roux-en-Y gastric bypass with a banded extended pouch
他の名前:
|
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 |
---|---|---|
Percentage Total Body Weight Loss (%TBWL)
時間枠:3 years
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((preoperative weight - current weight) / (preoperative weight)) x 100%.
Weight loss measured in kilograms
|
3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage Excess Weight Loss (%EWL)
時間枠:3 years
|
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%.
Weight loss measured in kilograms
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3 years
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BODY-Q: Quality of life after bariatric surgery
時間枠:3 years
|
BODY-Q: Patient reporterd outcome measurement, The questionnaire measures three domains; health related quality of life, appearance and experience of healthcare.
Each domain is composed of independently functioning scales.
Each scale contains different statements, which can be scored on four levels ranging from totally disagree to totally agree or from never to always.
The sum of levels ranging from 1 to 4 is the raw score of the different scales.
This score can be converted into a Rasch Transformed score ranging from 0, worst score, to 100, best score.
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3 years
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BAROS: Quality of life after bariatric surgery
時間枠:3 years
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BAROS; evaluates the results of obesity treatments by analyzing 3 domains: weight loss, changes in co-morbidities, and quality of life.
Up to 3 points are allowed for each, and points are deducted for complications and reoperations.
The final score classifies the results in 5 outcome groups, providing an objective definition of success or failure.
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3 years
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SF-36: Quality of life after bariatric surgery
時間枠:3 years
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SF-36; consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability
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3 years
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Gastroesophageal reflux disease
時間枠:3 years
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GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
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3 years
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Change in comorbidities in patients pre- and postoperative
時間枠:3 years
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Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
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3 years
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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。
Standard RYGBの臨床試験
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eSwiss Medical & Surgical CenterUniversity of Florence; FiorGen Foundation, Italy完了
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University of Oxford完了
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Medical University of South CarolinaIcahn School of Medicine at Mount Sinai完了
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Rigshospitalet, DenmarkTestcenter Danmark, Statens Serum Institut; Copenhagen Emergency Medical Services完了
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University of Illinois at Urbana-ChampaignCarle Foundation Hospital募集