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Videoendoscopic Pilonidal Sinus Surgery (videosinus)

Primary Purpose

Recurrence, Postoperative Complication

Status
Unknown status
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
videoendoscopic resection of pilonidal sinus
Sponsored by
SB Istanbul Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrence focused on measuring pilonidal sinus, new technique, videoendoscopic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

control

Arm Description

excision and primer repair surgical technique will be perform

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2011
Last Updated
April 23, 2012
Sponsor
SB Istanbul Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01583751
Brief Title
Videoendoscopic Pilonidal Sinus Surgery
Acronym
videosinus
Official Title
Videoendoscopic Pilonidal Sinus Surgery. A New Technique
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SB Istanbul Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence, Postoperative Complication
Keywords
pilonidal sinus, new technique, videoendoscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Experimental
Arm Description
excision and primer repair surgical technique will be perform
Intervention Type
Procedure
Intervention Name(s)
videoendoscopic resection of pilonidal sinus
Other Intervention Name(s)
Active Comparator: Control: Group 1, Procedure/Surgery: Videoendoscopic: Group-2
Intervention Description
Resection of pilonidal sinus tissue with videoendoscopic approach.
Primary Outcome Measure Information:
Title
recurrence rates
Description
primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.
Time Frame
six months
Secondary Outcome Measure Information:
Title
postoperative complications, wound healing
Description
Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
erhan aysan, assoc prof
Phone
+904531700
Email
dr@webcerrah.com
First Name & Middle Initial & Last Name or Official Title & Degree
adnan yukel, prof
Phone
+904531700
Email
ayuksel@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
erhan aysan, assoc prof
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34545
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
adnan yuksel, Prof
Phone
+902124531700
Email
ayuksel@bezmialem.edu.tr
First Name & Middle Initial & Last Name & Degree
erhan aysan, assoc. prof.
First Name & Middle Initial & Last Name & Degree
mahmut muslumanoglu, Prof

12. IPD Sharing Statement

Learn more about this trial

Videoendoscopic Pilonidal Sinus Surgery

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