Status:
UNKNOWN
The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other.
Lead Sponsor:
Boston Urogynecology Associates
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
Brief Summary
Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?
Detailed Description
Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure t...
Eligibility Criteria
Inclusion
- All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:
- Laparoscopic sacrocervicopexy
- Laparoscopic sacrocolpopexy
- Laparoscopic sacrohysteropexy
- Laparoscopic uterosacral ligament suspension
- Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires
Exclusion
- Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
- History of abdominal malignancy
- History of surgical debulking for previous malignancy
- Non-english speaking
- Pregnancy
- Hx of abdomino-pelvic radiation
- Contraindications to Sodium Phosphate
- Contraindications to laparoscopic surgery
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT01522261
Start Date
January 1 2012
End Date
January 1 2017
Last Update
April 20 2015
Active Locations (1)
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1
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138