NCT00981539

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

September 21, 2009

Last Update Submit

September 21, 2009

Conditions

Colon Cleansing

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • wound infection rate

    6 weeks post op

Secondary Outcomes (1)

  • rate of contamination of surgical field by stool during surgery

    day of surgery

Study Arms (2)

treatment : receives pre operative enema

ACTIVE COMPARATOR

one arm will receive pre operative enema

Procedure: enema

no enema

NO INTERVENTION

this group will not receive pre operative enema

Interventions

enemaPROCEDURE

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

Also known as: adult over the counter enema
treatment : receives pre operative enema

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female, AND
  • undergoing vaginal surgery for prolapse.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Illinois Urogynecology, LTD.

Oak Lawn, Illinois, 60453, United States

RECRUITING

Illinois Urogynecology, LTD.

Park Ridge, Illinois, 60068, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Enema

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Denise M Elser, MD

CONTACT

708-499-9800delser@iultd.org

Denise M Furlong, MD

CONTACT

708-499-9800dfurlong@iultd.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

US(2)