Bowel Preparation and Pelvic Organ Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

Official title:

Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937430
• Other study ID #: 09001
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: February 17, 2014
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Bowel preparation (Fleets enema)
Use of Bowel preparation (Fleets enema)

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the return of bowel function after pelvic organ prolapse surgery.		10 months	No