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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 21, 2009 | ||||||||
| Last Updated Date | September 21, 2009 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
wound infection rate [ Time Frame: 6 weeks post op ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
rate of contamination of surgical field by stool during surgery [ Time Frame: day of surgery ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications? | ||||||||
| Official Title ICMJE | Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery? | ||||||||
| 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. |
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| Detailed Description | The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
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| Condition ICMJE | Colon Cleansing | ||||||||
| Intervention ICMJE | Procedure: enema
pre operative rectal enema one adult bottle to be used rectally the night before surgery Other Name: adult over the counter enema |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 310 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00981539 | ||||||||
| Other Study ID Numbers ICMJE | IULTD-4747 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Denise M. Elser, MD, Illinois Urogynecology, LTD | ||||||||
| Study Sponsor ICMJE | Illinois Urogynecology, Ltd. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Illinois Urogynecology, Ltd. | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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