Bowel Preparation and Pelvic Organ Prolapse Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Bowel preparation (Fleets enema)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the return of bowel function after pelvic organ prolapse surgery.	10 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 9, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Bowel preparation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 09001