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Videoendoscopic Pilonidal Sinus Surgery (videosinus)

This study is currently recruiting participants.
Verified April 2012 by SB Istanbul Education and Research Hospital
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
History of Changes
  Purpose

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


Condition Intervention Phase
Recurrence
Postoperative Complication
 Procedure: videoendoscopic resection of pilonidal sinus
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Videoendoscopic Pilonidal Sinus Surgery. A New Technique

Further study details as provided by SB Istanbul Education and Research Hospital:

Primary Outcome Measures:
  • recurrence rates [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583751

Contacts
Contact: erhan aysan, assoc prof +904531700 dr@webcerrah.com
Contact: adnan yukel, prof +904531700 ayuksel@bezmialem.edu.tr

Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Turkey, 34545
Contact: adnan yuksel, Prof     +902124531700     ayuksel@bezmialem.edu.tr    
Principal Investigator: erhan aysan, assoc. prof.            
Principal Investigator: mahmut muslumanoglu, Prof            
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Investigators
Study Director: erhan aysan, assoc prof Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Erhan Aysan, Assoc Prof, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01583751     History of Changes
Other Study ID Numbers: pilonidal1
Study First Received: July 21, 2011
Last Updated: April 23, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by SB Istanbul Education and Research Hospital:
pilonidal sinus
new technique
videoendoscopic

Additional relevant MeSH terms:
Pilonidal Sinus
Postoperative Complications
Recurrence
Cysts
 Neoplasms
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on May 16, 2013