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Completed

NCT Number: NCT01805310

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bowel preparation

Other

Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.

Other names: Magnesium citrate

No bowel preparation

Other

Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Primary outcomes

  1. 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

  1. Surgeon perception of bowel preparation

    Time frame: 1 year

    Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty.

  2. Return of normal bowel function

    Time frame: 1 year

    A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives.

  3. Perioperative complications

    Time frame: 1 year

    Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.

Sponsors and collaborators

Lead sponsor

Halina M Zyczynski, MD

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2013
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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