Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
研究概览
简要总结
This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.
详细描述
This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine & Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.
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
Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse.
- •Age 18-90 years
- •Can read and understand the consent form and consents to the procedure
排除标准
- •Patients undergoing other procedures
- •Patients who do not consent to participate.
研究组 & 干预措施
Standard Insufflation Group
Patients will receive standard insufflation during surgery (15 mm Hg).
干预措施: Insufflation during surgery (Procedure)
Low Insufflation Group
Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).
干预措施: Insufflation during surgery (Procedure)
结局指标
主要结局
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
时间窗: Safety will be assessed at the two-week follow-up visit.
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
时间窗: Pain will be assessed at the two-week post-operative follow-up visit.
Pain will be assessed during the two-week post-operative period.
次要结局
未报告次要终点