Videoendoscopic Pilonidal Sinus Surgery (videosinus)

April 23, 2012 updated by: Erhan Aysan, SB Istanbul Education and Research Hospital

Videoendoscopic Pilonidal Sinus Surgery. A New Technique

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: erhan aysan, assoc prof
  • Phone Number: +904531700
  • Email: dr@webcerrah.com

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34545
        • Recruiting
        • Bezmialem Vakif University
        • Principal Investigator:
          • mahmut muslumanoglu, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rates
Time Frame: six months
primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Istanbul Education and Research Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

April 23, 2012

First Posted (ESTIMATE)

April 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pilonidal1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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