Postoperative Catheterization After Anterior Colporrhaphy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Atrium Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Atrium Medical Center
Collaborator:
Maastricht University
Information provided by:
Atrium Medical Center
ClinicalTrials.gov Identifier:
NCT00622076
First received: February 13, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 13, 2008 | ||||||||
| Last Updated Date | February 13, 2008 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy [ Time Frame: 6-8 hours after removal of catheter ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ] | ||||||||
| 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 | Postoperative Catheterization After Anterior Colporrhaphy | ||||||||
| Official Title ICMJE | Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele | ||||||||
| Brief Summary | Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Other Name: catheterization protocol |
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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 | 230 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00622076 | ||||||||
| Other Study ID Numbers ICMJE | 05-P-47 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Weemhoff, Atrium medical center Heerlen | ||||||||
| Study Sponsor ICMJE | Atrium Medical Center | ||||||||
| Collaborators ICMJE | Maastricht University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Atrium Medical Center | ||||||||
| Verification Date | January 2008 | ||||||||
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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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