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Videoendoscopic Pilonidal Sinus Surgery (videosinus)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by SB Istanbul Education and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
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

July 21, 2011
April 23, 2012
March 2011
March 2013   (final data collection date for primary outcome measure)
recurrence rates [ Time Frame: six months ] [ Designated as safety issue: Yes ]
primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.
Same as current
Complete list of historical versions of study NCT01583751 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Videoendoscopic Pilonidal Sinus Surgery
Videoendoscopic Pilonidal Sinus Surgery. A New Technique

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

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Recurrence
  • Postoperative Complication
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
Experimental: control
excision and primer repair surgical technique will be perform
Intervention: Procedure: videoendoscopic resection of pilonidal sinus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: erhan aysan, assoc prof +904531700 dr@webcerrah.com
Contact: adnan yukel, prof +904531700 ayuksel@bezmialem.edu.tr
Turkey
 
NCT01583751
pilonidal1
No
Erhan Aysan, SB Istanbul Education and Research Hospital
SB Istanbul Education and Research Hospital
Not Provided
Study Director: erhan aysan, assoc prof Bezmialem Vakif University
SB Istanbul Education and Research Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP