Port Size and Post-Operative Pain Perception by Patients
調査の概要
詳細な説明
Minimally invasive approaches trade a single longer incision for 4-5 smaller incisions that allow abdominal access and abdominal insufflation through "ports". The increase in operative times is mostly due to the need to pass suture, needles, cameras and instruments through the abdominal ports. While, it is intuitive that smaller abdominal ports will result in less pain at the incision site, the port size is also limited by instrument size and the size of the needle. When ports are smaller, it can take a little more time for a needle or instrument to be passed into the port.
There is a paucity of research comparing different port sizes as they relate to participate pain and operative time especially in a randomized controlled trial setting. The investigators goal would be to determine if there is a difference in pain perception by patients when the assistant port size varies by 50% (8 mm to 12 mm).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Illinois
-
Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- laparoscopic surgery for pelvic organ prolapse.
- proficiency in English .
Exclusion Criteria:
- Not proficiency in English
- Previous participation/randomization in the study at a previous visit
- Pregnant women cannot participate
- History of abdominal wall pain
- Chronic pain patients
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：防止
- 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：8mm Port
Participates will be randomized to have an 8 mm assistant port used during their surgery.
The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1).
The final pain assessment will be at the two weeks postoperative clinic visit.
|
Participate in this arm will have their procedure performed with an 8mm laparoscopic port.
|
|
実験的：12mm Port
Participates will be randomized to have an 12mm assistant port used during their surgery.
The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1).
The final pain assessment will be at the two weeks postoperative clinic visit.
|
Participate in this arm will have their procedure performed with a 12mm laparoscopic port.
|
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 |
|---|---|---|
|
Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points.
時間枠：2 weeks post-op visit
|
Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively.
|
2 weeks post-op visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented.
時間枠：Day of surgery
|
This will be measured by recording the time the first suture is placed when the physician asks for the mesh, to the time the incision is closed.
|
Day of surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Elizabeth R Mueller, MD、Loyola University Health System
出版物と役立つリンク
一般刊行物
- Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
- Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
- Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.
- McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004.
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。