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Bowel Preparation and Pelvic Organ Prolapse Surgery

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ClinicalTrials.gov Identifier: NCT00937430
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Bowel preparation (Fleets enema) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
Study Start Date : March 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Measure the return of bowel function after pelvic organ prolapse surgery. [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT00937430     History of Changes
Other Study ID Numbers: 09001
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical