Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Completed · Phase 4

Conditions studied: Pelvic Organ Prolapse, Prolapse

In brief

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.

Key facts

Study ID

NCT01805310

Run by

Halina M Zyczynski, MD

People needed

95

Starts

2013-02-01

Expected to finish

2017-08-01

Last updated by the study team

2018-01-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Age ≥ 18 years
• Planned laparoscopic or robotic-assisted sacral colpopexy

You may not qualify if…

• History of ulcerative colitis or Crohn's disease
• Prior large or small bowel resection
• Known diagnosis of gastroparesis
• Prior pelvic radiation
• History of abdominal or pelvic malignancy
• Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
• Pregnancy
• Known allergic reactions to components of the study products
• Known renal insufficiency
• Non-English speaking as the primary study questionnaires are all currently in English only

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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