Recruiting

Observational Study

Sponsor:

Illinois Urogynecology, Ltd.

Code:

NCT00981539

Conditions

Colon Cleansing

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

enema

Study Details

Brief 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.

Conditions

Colon Cleansing

Study ID

NCT00981539

Start date

Sep, 2009

Status verified date

Sep, 2009

Completion date

Sep, 2010

Anticipated

Primary completion date

Sep, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: treatment : receives pre operative enema

one arm will receive pre operative enema

no intervention: no enema

this group will not receive pre operative enema

Interventions

enema

pre operative rectal enema

one adult bottle to be used rectally the night before surgery

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Illinois Urogynecology, LTD.

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Illinois Urogynecology, LTD.

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Michael M Moen, MD

847-825-1590

Sara Kostant, MD

847-825-1590

More Information

Sponsor

Illinois Urogynecology, Ltd.

Last update posted

Sep 22, 2009

Last verified

Sep, 2009

Keywords

  • The focus of this study is to determine whether it is beneficial to administer enemas before surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illinois Urogynecology, Ltd. on 2009-09-22.