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Videoendoscopic Pilonidal Sinus Surgery (videosinus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583751
Recruitment Status : Unknown
Verified April 2012 by Erhan Aysan, SB Istanbul Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital

Brief Summary:
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Condition or disease Intervention/treatment Phase
Recurrence Postoperative Complication Procedure: videoendoscopic resection of pilonidal sinus Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Videoendoscopic Pilonidal Sinus Surgery. A New Technique
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: control
excision and primer repair surgical technique will be perform
Procedure: videoendoscopic resection of pilonidal sinus
Resection of pilonidal sinus tissue with videoendoscopic approach.
Other Names:
  • Active Comparator: Control: Group 1
  • Procedure/Surgery: Videoendoscopic: Group-2

Primary Outcome Measures :
  1. recurrence rates [ Time Frame: six months ]
    primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.

Secondary Outcome Measures :
  1. postoperative complications, wound healing [ Time Frame: 1 month ]
    Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • symptomatic pilonidal sinus disease
  • primer pilonidal sinus disease
  • noncomplicated pilonidal sinus disease

Exclusion Criteria:

  • Asymptomatic pilonidal sinus disease
  • Recurrence pilonidal sinus disease
  • complicated pilonidal sinus disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583751

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Contact: erhan aysan, assoc prof +904531700
Contact: adnan yukel, prof +904531700

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Bezmialem Vakif University Recruiting
Istanbul, Turkey, 34545
Contact: adnan yuksel, Prof    +902124531700   
Principal Investigator: erhan aysan, assoc. prof.         
Principal Investigator: mahmut muslumanoglu, Prof         
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
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Study Director: erhan aysan, assoc prof Bezmialem Vakif University

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Responsible Party: Erhan Aysan, Assoc Prof, SB Istanbul Education and Research Hospital Identifier: NCT01583751    
Other Study ID Numbers: pilonidal1
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012
Keywords provided by Erhan Aysan, SB Istanbul Education and Research Hospital:
pilonidal sinus
new technique
Additional relevant MeSH terms:
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Pilonidal Sinus
Postoperative Complications
Disease Attributes
Pathologic Processes