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

Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and 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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy
• Intervention / Treatment: Drug: Fleet Enema (sodium biphosphate and sodium phosphate)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Matthew Siedhoff, MD, MSCR, UNC OB-GYN Division of Advanced Laparoscopy and Pelvic Pain

Publications and helpful links

General Publications

• Siedhoff MT, Clark LH, Hobbs KA, Findley AD, Moulder JK, Garrett JM. Mechanical bowel preparation before laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):562-567. doi: 10.1097/AOG.0000000000000121.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Laparoscopic hysterectomy,laparoscopic sacrocolpopexy,bowel prep
• Other Study ID Numbers: 11-1602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No