Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?

September 21, 2009 updated by: Illinois Urogynecology, Ltd.

Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?

Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Illinois Urogynecology, LTD.
        • Contact:
          • Michael M Moen, MD
          • Phone Number: 847-825-1590
        • Contact:
          • Sara Kostant, MD
          • Phone Number: 847-825-1590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • female, AND
  • undergoing vaginal surgery for prolapse.

Exclusion Criteria:

  • pregnant women,
  • age younger than eighteen,
  • male sex, OR
  • concurrent abdominal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment : receives pre operative enema
one arm will receive pre operative enema
Procedure: enema

pre operative rectal enema

one adult bottle to be used rectally the night before surgery

Other Names:
  • adult over the counter enema
No Intervention: no enema
this group will not receive pre operative enema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
wound infection rate
Time Frame: 6 weeks post op
6 weeks post op

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of contamination of surgical field by stool during surgery
Time Frame: day of surgery
day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Illinois Urogynecology, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IULTD-4747

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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