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

Study Overview
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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.

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

Conditions
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Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy

Intervention / Treatment
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* Drug: Fleet Enema (sodium biphosphate and sodium phosphate)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical Bowel Prep Group<br>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. | Drug: Fleet Enema (sodium biphosphate and sodium phosphate)<br>* 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<br>|
| No Intervention: No Bowel Prep Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon's assessment of surgical field visual quality |  | immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon evaluation of patient outcomes | Survey will include questions regarding operative time, operative complications, postoperative complications, and length of hospitalization. | immediately after surgery | 
| Patient reported satisfaction | 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. | immediately prior to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic hysterectomy,laparoscopic sacrocolpopexy,bowel prep