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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Mechanical Bowel Prep Group

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.

Group Type EXPERIMENTAL

Fleet Enema (sodium biphosphate and sodium phosphate)

Intervention Type 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

No Bowel Prep Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fleet Enema (sodium biphosphate and sodium phosphate)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No