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
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital Identifier:
First received: July 21, 2011
Last updated: April 23, 2012
Last verified: April 2012
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Condition Intervention Phase
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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01583751

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

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
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 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

Additional relevant MeSH terms:
Pilonidal Sinus
Postoperative Complications
Disease Attributes
Pathologic Processes processed this record on December 01, 2015