Status:
COMPLETED
Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Value of the Bowel Preparation and Diet Change Versus no Intervention
Preoperative Bowel Regimen
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
Preoperative bowel preparation for surgical management of pelvic floor disorders is performed inconsistently, and includes no prep, the use of dietary changes or bowel altering interventions. Retrospe...
Eligibility Criteria
Inclusion
- Age ≥ 19
- Female
- Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)
Exclusion
- Male
- Pregnant, planning pregnancy, or less than 1 year from delivery
- History of total colectomy or prior ileostomy
- Inflammatory bowel disorder (Crohn's disease and ulcerative colitis) formally diagnosed
- Inability to understand written study material (including non-English speaking)
- Inability to give consent
- Presently diagnosed colorectal cancer
- Undergoing chemotherapy and/or radiation
- Chronic constipation suggestive of colonic inertia defined as fewer that 3 stools per week (Rome III guidelines)
- Severe neurological diseases (such as Multiple Sclerosis)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01431040
Start Date
January 1 2011
End Date
August 1 2013
Last Update
June 16 2014
Active Locations (1)
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1
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233