Clinical trial NCT01805310: Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Official title: Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Prolapse
Keywords: Pelvic organ prolapse
Prolapse
Cathartics
Mechanical bowel preparation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Female
* 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

Primary outcomes:
measure: PAC-SYM
timeFrame: 1 year
Secondary outcomes:
measure: Surgeon perception of bowel preparation
timeFrame: 1 year
measure: Return of normal bowel function
timeFrame: 1 year
measure: Perioperative complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kelly L Kantartzis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Halina M Zyczynski, MD
role: PRINCIPAL_INVESTIGATOR
References: