Bowel Preparation and Pelvic Organ Prolapse Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT00937430
First received: July 9, 2009
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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 Intervention
Pelvic Organ Prolapse
Other: Bowel preparation (Fleets enema)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Measure the return of bowel function after pelvic organ prolapse surgery. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937430

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Study Director: Rachel N Pauls, M.D. TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT00937430     History of Changes
Other Study ID Numbers: 09001
Study First Received: July 9, 2009
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Pelvic organ prolapse
Bowel preparation

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014