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Bowel Preparation and Pelvic Organ Prolapse Surgery

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bowel preparation (Fleets enema)
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Bowel preparation

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bowel preparation group

No Bowel preparation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 9, 2009
Last Updated
February 17, 2014
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00937430
Brief Title
Bowel Preparation and Pelvic Organ Prolapse Surgery
Official Title
Bowel Preparation and Return of Bowel Function After Pelvic Organ Prolapse Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, Bowel preparation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bowel preparation group
Arm Type
Experimental
Arm Description
Patients randomized to this arm will perform a bowel preparation prior to their pelvic organ prolapse surgery.
Arm Title
No Bowel preparation group
Arm Type
No Intervention
Arm Description
Patients randomized to this group will not be performing a bowel preparation prior to their pelvic organ prolapse surgery.
Intervention Type
Other
Intervention Name(s)
Bowel preparation (Fleets enema)
Intervention Description
Use of Bowel preparation (Fleets enema)
Primary Outcome Measure Information:
Title
Measure the return of bowel function after pelvic organ prolapse surgery.
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel N Pauls, M.D.
Organizational Affiliation
TriHealth Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

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Bowel Preparation and Pelvic Organ Prolapse Surgery

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