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Clinical Trials/NCT01805310
NCT01805310
Completed
Phase 4

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Halina M Zyczynski, MD1 site in 1 country95 target enrollmentFebruary 2013

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Halina M Zyczynski, MD
Enrollment
95
Locations
1
Primary Endpoint
PAC-SYM
Status
Completed
Last Updated
8 years ago

Overview

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 bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.

Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.

This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Halina M Zyczynski, MD

MD

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Planned laparoscopic or robotic-assisted sacral colpopexy

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

PAC-SYM

Time Frame: 1 year

Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool.

Secondary Outcomes

  • Perioperative complications(1 year)
  • Surgeon perception of bowel preparation(1 year)
  • Return of normal bowel function(1 year)

Study Sites (1)

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