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
Recruitment status was Recruiting
Sponsor:
Illinois Urogynecology, Ltd.
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
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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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
| Official Title: | Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery? |
Resource links provided by NLM:
Further study details as provided by Illinois Urogynecology, Ltd.:
Primary Outcome Measures:
- wound infection rate [ Time Frame: 6 weeks post op ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- rate of contamination of surgical field by stool during surgery [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided
| Responsible Party: | Denise M. Elser, MD, Illinois Urogynecology, LTD |
| ClinicalTrials.gov Identifier: | NCT00981539 History of Changes |
| Other Study ID Numbers: | IULTD-4747 |
| Study First Received: | September 21, 2009 |
| Last Updated: | September 21, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Illinois Urogynecology, Ltd.:
|
The focus of this study is to determine whether it is beneficial to administer enemas before surgery |
Additional relevant MeSH terms:
|
Uterine Prolapse Uterine Diseases Genital Diseases, Female |
Pelvic Organ Prolapse Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013