NCT01044212已完成不适用
Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to First Post-op Bowel Movement
研究概览
简要总结
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.
- •Procedures may include:
- •robot-assisted laparoscopic sacrocolpopexy
- •sacrospinous ligament suspension
- •uterosacral ligament suspension/paravaginal defect repair
- •colpocleisis
- •cystocele repair
- •Additional procedures may include:
- •hysterectomy
- •adnexectomy
- •culdoplasty
- •minimally invasive sling procedure (TVT or TOT)
- •periurethral collagen injections
- •enterocele repair
排除标准
- •Planning to undergo laparotomy.
- •Undergoing rectocele or perineocele repair as part of surgery.
- •Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
- •Presence of a colostomy.
- •Chronic kidney disease
- •Insulin-dependent diabetes mellitus
- •Known cardiac disease
- •Gastric ulcers
- •Difficulty swallowing or esophageal stricture
- •Persistent nausea and vomiting
- •Signs and symptoms consistent with bowel obstruction
研究组 & 干预措施
Docusate
Active Comparator
Docusate is the standard of care regimen
干预措施: Docusate (Drug)
Bowel medications
Experimental
Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
干预措施: Bowel medications (Drug)
结局指标
主要结局
Time to First Post-op Bowel Movement
时间窗: Within 1 week of surgery
The time to first post-operative bowel movement was measured in hours after surgery.
次要结局
- Consistency of First Postoperative Bowel Movement(Within 1 week of surgery)
- Pain Level Associated With First Postoperative Bowel Movement(Within 1 week of surgery)
研究者
Gunhilde Buchsbaum
Professor
University of Rochester
研究点 (1)
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