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

NCT ID: NCT00981539

Last Updated: 2009-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Colon Cleansing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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treatment : receives pre operative enema

one arm will receive pre operative enema

Group Type ACTIVE_COMPARATOR

enema

Intervention Type PROCEDURE

pre operative rectal enema

one adult bottle to be used rectally the night before surgery

no enema

this group will not receive pre operative enema

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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enema

pre operative rectal enema

one adult bottle to be used rectally the night before surgery

Intervention Type PROCEDURE

Other Intervention Names

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adult over the counter enema

Eligibility Criteria

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Inclusion Criteria

* female, AND
* undergoing vaginal surgery for prolapse.

Exclusion Criteria

* pregnant women,
* age younger than eighteen,
* male sex, OR
* concurrent abdominal surgery.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Illinois Urogynecology, Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Illinois Urogynecology, LTD

Locations

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Illinois Urogynecology, LTD.

Oak Lawn, Illinois, United States

Site Status RECRUITING

Illinois Urogynecology, LTD.

Park Ridge, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Denise M Elser, MD

Role: CONTACT

708-499-9800

Denise M Furlong, MD

Role: CONTACT

708-499-9800

Facility Contacts

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Elser

Role: primary

708-499-9800

Role: backup

Michael M Moen, MD

Role: primary

847-825-1590

Sara Kostant, MD

Role: backup

847-825-1590

Related Links

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Other Identifiers

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IULTD-4747

Identifier Type: -

Identifier Source: org_study_id

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