Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
- realize the benefits of less invasive surgery by reducing the recovery time,
- experience less physical discomfort associated with traditional procedures
- have virtually no visible scarring following this type of surgery.
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
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Durango、メキシコ、34000
- Universidad Juarez del Estado de Durango, Mexico
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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:
- Adult (> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Exclusion Criteria:
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly > 65 y/o.
- Body Mass Index > 35 mg/kg2.
- Complicated or acute cholecystitis.
- Elevation of liver function tests.
- Acute abdomen.
- Intra-abdominal abscess.
- Coagulopathy.
- Imperforated hymen.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
Transvaginal NOTES Cholecystectomy (Phase 1)
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Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
他の名前：
|
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アクティブコンパレータ：2
Laparoscopic Cholecystectomy (Phase 2)
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Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
他の名前：
|
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実験的：3
Transvaginal NOTES cholecystectomy (Phase 2)
|
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
他の名前：
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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 |
時間枠 |
|---|---|
|
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
時間枠：12 months
|
12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
時間枠：12 months
|
12 months
|
協力者と研究者
捜査官
- 主任研究者：Homero Rivas, MD、Hospital de La Paz
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。