Bowel Preparation and Pelvic Organ Prolapse Surgery

NCT ID: NCT00937430

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Bowel preparation group

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

Group Type: EXPERIMENTAL

Bowel preparation (Fleets enema)

Intervention Type: OTHER

Use of Bowel preparation (Fleets enema)

No Bowel preparation group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bowel preparation (Fleets enema)

Use of Bowel preparation (Fleets enema)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel N Pauls, M.D.

Role: STUDY_DIRECTOR

TriHealth Inc.

Locations

Good Samaritan Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

09001

Identifier Type: -

Identifier Source: org_study_id