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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthew Siedhoff, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01576965
First received: April 11, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy
Drug: Fleet Enema (sodium biphosphate and sodium phosphate)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Surgeon's assessment of surgical field visual quality [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgeon evaluation of patient outcomes [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]
    Survey will include questions regarding operative time, operative complications, postoperative complications, and length of hospitalization.

  • Patient reported satisfaction [ Time Frame: immediately prior to surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: April 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576965

Locations
United States, North Carolina
UNC Department of Obstetrics and Gynecology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Matthew Siedhoff, MD, MSCR UNC OB-GYN Division of Advanced Laparoscopy and Pelvic Pain
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Siedhoff, MD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01576965     History of Changes
Other Study ID Numbers: 11-1602
Study First Received: April 11, 2012
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Laparoscopic hysterectomy,laparoscopic sacrocolpopexy,bowel prep

ClinicalTrials.gov processed this record on September 29, 2014