Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
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.
Investigators
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)