The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.
研究概览
简要总结
We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.
详细描述
Right now, doctors use mild laxatives and stool softeners to help you have a bowel movement earlier and with less pain after surgery. Sometimes if the stool softener or mild laxatives do not work, you may need to use stronger laxatives or enemas. We want to see if specifically using SennaS is better for having a bowel movement soon after surgery and with less pain. SennaS is FDA approved for constipation. It has a stool softener and a mild laxative and has been shown to be safe and effective for treating constipation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Women undergoing pelvic reconstructive surgery, including any combination of:
- •Posterior/rectocele repair
- •Paravaginal repair
- •Anterior/cystocele repair
- •Suburethral sling
- •Abdominal sacrocolpopexy
- •Midurethral sling (obturator pass)
- •Burch urethropexy
- •Midurethral sling (retropubic pass)
- •Colpocleisis/colpectomy
- •Uterosacral ligament suspension
- •Sacrospinous ligament fixation
- •Enterocele repair
- •Anal sphincter repair
- •Perineorrhaphy
- •Use of graft material (synthetic or biologic) of any form/size does not affect inclusion, use of laparoscopy or robotic-assisted laparoscopy does not affect inclusion
排除标准
- •Pregnancy (based on positive urine or serum ß-HCG measurement preoperatively in women who are not menopausal or have prior hysterectomy)
- •Concurrent bowel resection,
- •Hirschsprung's Disease or gastroparesis,
- •Irritable & inflammatory bowel disease (Crohn's Disease/ulcerative colitis) formally diagnosed,
- •Clostridium difficile colitis during present hospitalization
- •Inability to understand written study material,
- •Inability to give consent
- •Rectal bleeding or presently diagnosed colorectal cancer,
- •Documented preoperative daily use of SennaS for more than 3 weeks,
- •Known allergy to SennaS
- •Inability to use suppositories/enemas
研究组 & 干预措施
SennaS
This group of participants will receive SennaS to use after surgery.
干预措施: Senna+ docusate (Drug)
Placebo
This group of participants will receive placebo pills to use after surgery.
干预措施: placebo (Drug)
结局指标
主要结局
1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.
时间窗: 7 weeks post-operatively
次要结局
- Straining and pain with bowel movements in the immediate post-operative period(First post-operative week)