Videoendoscopic Pilonidal Sinus Surgery (videosinus)
This study is currently recruiting participants.
Verified April 2012 by SB Istanbul Education and Research Hospital
Sponsor:
SB Istanbul Education and Research Hospital
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01583751
First received: July 21, 2011
Last updated: April 23, 2012
Last verified: April 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 21, 2011 | ||||||||
| Last Updated Date | April 23, 2012 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
recurrence rates [ Time Frame: six months ] [ Designated as safety issue: Yes ] primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01583751 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
postoperative complications, wound healing [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one. |
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| 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 | Videoendoscopic Pilonidal Sinus Surgery | ||||||||
| Official Title ICMJE | Videoendoscopic Pilonidal Sinus Surgery. A New Technique | ||||||||
| Brief Summary | This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach. |
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| Detailed Description | Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: videoendoscopic resection of pilonidal sinus
Resection of pilonidal sinus tissue with videoendoscopic approach.
Other Names:
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| Study Arm (s) | Experimental: control
excision and primer repair surgical technique will be perform
Intervention: Procedure: videoendoscopic resection of pilonidal sinus |
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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 | 60 | ||||||||
| Estimated Completion Date | March 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01583751 | ||||||||
| Other Study ID Numbers ICMJE | pilonidal1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Erhan Aysan, SB Istanbul Education and Research Hospital | ||||||||
| Study Sponsor ICMJE | SB Istanbul Education and Research Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | SB Istanbul Education and Research Hospital | ||||||||
| Verification Date | April 2012 | ||||||||
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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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