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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Illinois Urogynecology, Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Illinois Urogynecology, Ltd.
ClinicalTrials.gov Identifier:
NCT00981539
First received: September 21, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 21, 2009
September 21, 2009
September 2009
September 2010   (final data collection date for primary outcome measure)
wound infection rate [ Time Frame: 6 weeks post op ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
rate of contamination of surgical field by stool during surgery [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Colon Cleansing
Procedure: enema

pre operative rectal enema

one adult bottle to be used rectally the night before surgery

Other Name: adult over the counter enema
  • Active Comparator: treatment : receives pre operative enema
    one arm will receive pre operative enema
    Intervention: Procedure: enema
  • No Intervention: no enema
    this group will not receive pre operative enema
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
310
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female, AND
  • undergoing vaginal surgery for prolapse.

Exclusion Criteria:

  • pregnant women,
  • age younger than eighteen,
  • male sex, OR
  • concurrent abdominal surgery.
Female
18 Years and older
Yes
Contact: Denise M Elser, MD 708-499-9800 delser@iultd.org
Contact: Denise M Furlong, MD 708-499-9800 dfurlong@iultd.org
United States
 
NCT00981539
IULTD-4747
No
Denise M. Elser, MD, Illinois Urogynecology, LTD
Illinois Urogynecology, Ltd.
Not Provided
Not Provided
Illinois Urogynecology, Ltd.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP