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

University of North Carolina (UNC)

Status: Completed

Conditions: Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy

Treatments: Drug: Fleet Enema (sodium biphosphate and sodium phosphate)

Study type: Interventional

Funder types: Other

Identifiers

NCT01576965

11-1602

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Mechanical Bowel Prep Group

Experimental group

Description:

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.

Treatment:

Drug: Fleet Enema (sodium biphosphate and sodium phosphate)

No Bowel Prep Group

No Intervention group

Description:

Participants randomly assigned to this group will not have the bowel prep treatment before the 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.