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videosinus: Videoendoscopic Pilonidal Sinus Surgery

Sponsor
SB Istanbul Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01583751
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2011
Anticipated Primary Completion Date :
Mar 1, 2013
Anticipated Study Completion Date :
Mar 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. recurrence rates [six months]

      primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.

    Secondary Outcome Measures

    1. postoperative complications, wound healing [1 month]

      Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakif University Istanbul Turkey 34545

    Sponsors and Collaborators

    • SB Istanbul Education and Research Hospital

    Investigators

    • Study Director: erhan aysan, assoc prof, Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erhan Aysan, Assoc Prof, SB Istanbul Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01583751
    Other Study ID Numbers:
    • pilonidal1
    First Posted:
    Apr 24, 2012
    Last Update Posted:
    Apr 24, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Erhan Aysan, Assoc Prof, SB Istanbul Education and Research Hospital
    pilonidal sinus
    new technique
    videoendoscopic
    Additional relevant MeSH terms:
    Pilonidal Sinus
    Recurrence
    Postoperative Complications

    Study Results

    No Results Posted as of Apr 24, 2012