NCT01805310

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Halina M Zyczynski, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations. Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations. This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.

Conditions

• Pelvic Organ Prolapse
• Prolapse

Interventions

Type	Name	Description
OTHER	Bowel preparation	Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.
OTHER	No bowel preparation	Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2013-03-06
• Last updated: 2018-01-09

Locations

1 site across 1 country: United States