Bowel Preparation and Pelvic Organ Prolapse Surgery

NCT00937430 | Completed DMC

• 1 other identifier: 09001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Bowel preparation

Outcome Measures

Primary Outcomes (1)

• Measure the return of bowel function after pelvic organ prolapse surgery.

  10 months

Study Arms (2)

Bowel preparation group

EXPERIMENTAL

Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery.

Other: Bowel preparation (Fleets enema)

No Bowel preparation group

NO INTERVENTION

Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery.

Interventions

Bowel preparation (Fleets enema) OTHER

Use of Bowel preparation (Fleets enema)

Bowel preparation group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel N Pauls, M.D.

  TriHealth Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

US (1)