Status:
COMPLETED
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Lead Sponsor:
Halina M Zyczynski, MD
Conditions:
Pelvic Organ Prolapse
Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bow...
Eligibility Criteria
Inclusion
- Female
- Age ≥ 18 years
- Planned laparoscopic or robotic-assisted sacral colpopexy
Exclusion
- History of ulcerative colitis or Crohn's disease
- Prior large or small bowel resection
- Known diagnosis of gastroparesis
- Prior pelvic radiation
- History of abdominal or pelvic malignancy
- Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
- Pregnancy
- Known allergic reactions to components of the study products
- Known renal insufficiency
- Non-English speaking as the primary study questionnaires are all currently in English only
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01805310
Start Date
February 1 2013
End Date
August 1 2017
Last Update
January 9 2018
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213