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

I

Illinois Urogynecology, Ltd.

Status

Unknown

Conditions

Colon Cleansing

Treatments

Procedure: enema

Study type

Interventional

Funder types

Other

Identifiers

NCT00981539
IULTD-4747

Details and patient eligibility

About

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.

Full description

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

Enrollment

310 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • female, AND
  • undergoing vaginal surgery for prolapse.

Exclusion criteria

  • pregnant women,
  • age younger than eighteen,
  • male sex, OR
  • concurrent abdominal surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

310 participants in 2 patient groups

treatment : receives pre operative enema
Active Comparator group
Description:
one arm will receive pre operative enema
Treatment:
Procedure: enema
no enema
No Intervention group
Description:
this group will not receive pre operative enema

Trial contacts and locations

2

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Central trial contact

Denise M Furlong, MD; Denise M Elser, MD

Data sourced from clinicaltrials.gov

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