Surgical Treatment of High Perianal Fistulas (LIFTRAF)
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| ClinicalTrials.gov Identifier: NCT01997645 |
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Recruitment Status : Unknown
Verified November 2013 by Otakar Sotona, University Hospital Hradec Kralove.
Recruitment status was: Recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | November 22, 2013 | |||||||||
| First Posted Date ICMJE | November 28, 2013 | |||||||||
| Last Update Posted Date | November 28, 2013 | |||||||||
| Study Start Date ICMJE | November 2013 | |||||||||
| Estimated Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Recurrence rate [ Time Frame: One year ] Fistula recurrence will be defined according to AGA (American Gastroenterological Association) criteria as a purulent secretion from external fistula opening followed the compression.
Fistula recurrence will be confirmed by evaluation under anesthesia (followed by drainage).
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Surgical Treatment of High Perianal Fistulas | |||||||||
| Official Title ICMJE | Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas | |||||||||
| Brief Summary | Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously. Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review. Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%). The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas. |
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| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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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 | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
140 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Study Completion Date ICMJE | Not Provided | |||||||||
| Estimated Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Czech Republic | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01997645 | |||||||||
| Other Study ID Numbers ICMJE | FN HK CP 2013 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Otakar Sotona, University Hospital Hradec Kralove | |||||||||
| Study Sponsor ICMJE | University Hospital Hradec Kralove | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | University Hospital Hradec Kralove | |||||||||
| Verification Date | November 2013 | |||||||||
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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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