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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Illinois Urogynecology, Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981539
First Posted: September 22, 2009
Last Update Posted: September 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Illinois Urogynecology, Ltd.
  Purpose
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.

Condition Intervention
Colon Cleansing Procedure: enema

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?

Further study details as provided by Illinois Urogynecology, Ltd.:

Primary Outcome Measures:
  • wound infection rate [ Time Frame: 6 weeks post op ]

Secondary Outcome Measures:
  • rate of contamination of surgical field by stool during surgery [ Time Frame: day of surgery ]

Estimated Enrollment: 310
Study Start Date: September 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: adult over the counter enema
No Intervention: no enema
this group will not receive pre operative enema

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female, AND
  • undergoing vaginal surgery for prolapse.

Exclusion Criteria:

  • pregnant women,
  • age younger than eighteen,
  • male sex, OR
  • concurrent abdominal surgery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981539


Contacts
Contact: Denise M Elser, MD 708-499-9800 delser@iultd.org
Contact: Denise M Furlong, MD 708-499-9800 dfurlong@iultd.org

Locations
United States, Illinois
Illinois Urogynecology, LTD. Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Elser    708-499-9800    delser@iultd.org   
Contact       dfurlong@iultd.org   
Illinois Urogynecology, LTD. Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Michael M Moen, MD    847-825-1590      
Contact: Sara Kostant, MD    847-825-1590      
Sponsors and Collaborators
Illinois Urogynecology, Ltd.
  More Information

Additional Information:
Responsible Party: Denise M. Elser, MD, Illinois Urogynecology, LTD
ClinicalTrials.gov Identifier: NCT00981539     History of Changes
Other Study ID Numbers: IULTD-4747
First Submitted: September 21, 2009
First Posted: September 22, 2009
Last Update Posted: September 22, 2009
Last Verified: September 2009

Keywords provided by Illinois Urogynecology, Ltd.:
The focus of this study is to determine whether it is beneficial to administer enemas before surgery