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OpenTrials
Completed

NCT Number: NCT01576965

Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to view necessary anatomy for the surgery, which will be assessed by a questionnaire completed at the end of your operation by the surgeon. We hypothesize that bowel preparation before laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary anatomy for the surgery.

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Key information

Conditions

Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Department of Obstetrics and Gynecology

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women undergoing planned laparoscopic hysterectomy, with or without concomitant sacrocolpopexy, for benign indications with members of the Advanced Laparoscopy & Pelvic Pain division and the Urogynecology division at UNC.

Exclusion criteria

  • Patients with known or suspected malignancy and those with severe endometriosis of the posterior cul-de-sac where bowel resection
  • Pregnant women.
  • Women under 18 years old.
  • Women who cannot provide informed consent.

Treatment and study plan

Fleet Enema (sodium biphosphate and sodium phosphate)

Drug

Those assigned to the mechanical bowel prep group will be asked to administer a single sodium phosphate enema rectally before going to bed the night before surgery. If stool is not clear in the morning, mechanical bowel prep subjects will administer one additional enema the morning of surgery

Primary outcomes

  1. Surgeon's assessment of surgical field visual quality

    Time frame: immediately after surgery

Secondary outcomes

  1. Surgeon evaluation of patient outcomes

    Time frame: immediately after surgery

    Survey will include questions regarding operative time, operative complications, postoperative complications, and length of hospitalization.

  2. Patient reported satisfaction

    Time frame: immediately prior to surgery

    Participants will complete questionnaires regarding their relative comfort in the preoperative period. Participants will also be asked if they were able to complete the regimen and if they would be willing to perform the same preparation before a future surgery.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 13, 2012
Registry last updated
Mar 14, 2017

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.