Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Postoperative pain measured with visual analog scale
研究概览
简要总结
Introduction
Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL).
Materiel and Methods
We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain.
We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study.
Expected results
We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presumed benign adnexal disease Adnexal pathologies treated between 7:00 AM and 10:00 PM Signed informed consent Patient presenting no contraindication to laparoscopy
排除标准
- •Salpingitis and twist annexes. The patient does not fluently read French.
结局指标
主要结局
Postoperative pain measured with visual analog scale
时间窗: Postoperative pain evaluation at 24 hours
次要结局
- Blood lost in milliliters (mls)(1 hour)
- Postoperative pain measured with visual analog scale(2 hours, 4 hours, 6 hours, 1 month)
- timing in minutes between incision and suture(4 hours)
- Inpatient numbers of days(1 month)
- Non steroid anti inflammatory numbers of pills taken(1 month)
- number of convertion to laparotomy, Postoperative hernia(1 month)
- visual analog scale for cosmetic satisfaction(1 year)