Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Postoperative pain scores via Visual Analog Scale
研究概览
简要总结
Our study aims to determine postoperative pain outcomes when comparing port site > 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.
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
- Single (Participant)
盲法说明
This will be a prospective, singled-blinded, randomized controlled study. Eligible patients who provide consent will be randomized into one of two arms either undergoing fascial closure with a fascial closure device or traditional direct closure on the day of surgery. Every patient will have equal probability of being assigned to either study arm. The patients will be blinded to which study arm they have been assigned to, but providers will be aware due to the nature of study topic.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 or older.
- •Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site > 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
- •Patients willing and able to give informed consent.
- •Patients capable and willing to return for follow up and complete pain diaries.
排除标准
- •Patients unable to return for follow up.
- •Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
- •Patients undergoing laparoscopic surgery that does not require a port site >10 mm.
结局指标
主要结局
Postoperative pain scores via Visual Analog Scale
时间窗: Through 2 weeks postoperatively
A 20 mm difference in VAS score and a 2-unit difference on a 10-point pain scale have been described as a clinically significant difference between treatment groups.
次要结局
- Quantity of narcotics consumed in postoperative period(Through 2 weeks postoperatively)
- Length of hospital stay(Through study completion, up to 6 months)
- Fascial closure operating time(Duration of fascial closure operating time)
- Postoperative complication(Through 6 weeks postoperatively)
研究者
Jessica G Putman
Fellow Investigator
University of Tennessee