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

Colon Cleansing Clinical Trial

Official title:

Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00981539
• Other study ID #: IULTD-4747
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2009
• Last updated: September 21, 2009
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: Illinois Urogynecology, Ltd.
• Contact: Denise M Elser, MD
• Phone: 708-499-9800
• Email: delser[@]iultd.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female, AND

• undergoing vaginal surgery for prolapse.

Exclusion Criteria:

• pregnant women,

• age younger than eighteen,

• male sex, OR

• concurrent abdominal surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colon Cleansing

Intervention

Procedure:
• enema
pre operative rectal enema one adult bottle to be used rectally the night before surgery

Locations

Country	Name	City	State
United States	Illinois Urogynecology, LTD.	Oak Lawn	Illinois
United States	Illinois Urogynecology, LTD.	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Illinois Urogynecology, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infection rate		6 weeks post op	Yes
Secondary	rate of contamination of surgical field by stool during surgery		day of surgery	Yes

External Links

•   Practice site