Bowel Preparation and Pelvic Organ Prolapse Surgery

• Sponsor: TriHealth Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00937430
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: Bowel preparation (Fleets enema)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bowel preparation group Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery.	Other: Bowel preparation (Fleets enema); Use of Bowel preparation (Fleets enema)
No Intervention: No Bowel preparation group Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery.

Outcome Measures

Primary Outcome Measures

1. Measure the return of bowel function after pelvic organ prolapse surgery. [10 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• TriHealth Inc.

Investigators

• Study Director: Rachel N Pauls, M.D., TriHealth Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT00937430
• Other Study ID Numbers: 09001
• First Posted: Jul 13, 2009
• Last Update Posted: Feb 19, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by TriHealth Inc.: Pelvic organ prolapse; Bowel preparation
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 19, 2014