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

Not Applicable

Completed

• Conditions: Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy
• Interventions: Drug: Fleet Enema (sodium biphosphate and sodium phosphate)

• Registration Number: NCT01576965
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-13
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-02
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical Bowel Prep Group	Fleet Enema (sodium biphosphate and sodium phosphate)	Half of the subjects will be randomized to a group that does mechanical bowel preparation with sodium phosphate enema. 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. All subjects will be instructed to restrict their diet to clear liquids the day prior to their surgery and to continue this diet after midnight, save a small sip of water for medications in the morning.

Primary Outcome Measures

Name	Time	Method
Surgeon's assessment of surgical field visual quality	immediately after surgery

Secondary Outcome Measures

Name	Time	Method
Surgeon evaluation of patient outcomes	immediately after surgery	Survey will include questions regarding operative time, operative complications, postoperative complications, and length of hospitalization.
Patient reported satisfaction	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.

Trial Locations

Locations (1)

UNC Department of Obstetrics and Gynecology; 🇺🇸 Chapel Hill, North Carolina, United States