Bowel Preparation and Pelvic Organ Prolapse Surgery

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Bowel preparation (Fleets enema)

• Registration Number: NCT00937430
• Lead Sponsor: TriHealth Inc.

Brief Summary

The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Are between the ages of 21-90 years.
• Have a posterior vaginal wall prolapse.
• Are undergoing vaginal prolapse reconstructive surgery including posterior repair with suspension of the vaginal apex (top) to the ligaments in your pelvis, repair of the cul de sac or "enterocele", with or without anti-incontinence surgery.
• Are receiving general anesthesia.

Exclusion Criteria

• Patient undergoing concomitant anal sphincteroplasty, rectovaginal fistula repair, rectopexy, or rectal resection/reanastomosis.
• Patient undergoing any mesh augmentation.
• Patient with any neurological condition involving bowel function.
• Patient on regular narcotic medication preoperatively.
• Patient does not want to be in the group she was randomized to.
• Patient currently pregnant or planning to become pregnant, or breastfeeding.
• Patient with ascites.
• Patient with known or suspected gastrointestinal obstruction or perforation.
• Patient with history of hyperparathyroidism.
• Patient with dehydration.
• Patient with active inflammatory bowel disease.
• Patients with congestive heart failure.
• Patients with dialysis dependent renal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bowel preparation group	Bowel preparation (Fleets enema)	Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery.

Primary Outcome Measures

Name	Time	Method
Measure the return of bowel function after pelvic organ prolapse surgery.	10 months

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States