search
Back to results

Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus

Primary Purpose

Pilonidal Sinus, Pilonidal Cyst

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
karydakis flap
laying open
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring pilonidal sinus, karydakis, laying open

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

Sites / Locations

  • Tehran University of medical Sciences, Deputy of Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Excision of the cyst and Karydakis flap

Excision of the cyst and laying open

Outcomes

Primary Outcome Measures

Recurrence

Secondary Outcome Measures

Work off date, Healing Time

Full Information

First Posted
July 14, 2008
Last Updated
December 15, 2014
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00716937
Brief Title
Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus
Official Title
Recurrence, Complications, Work-off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Excision With Healing by Secondary Intention (EHSI)Technique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus, Pilonidal Cyst
Keywords
pilonidal sinus, karydakis, laying open

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Excision of the cyst and Karydakis flap
Arm Title
2
Arm Type
Experimental
Arm Description
Excision of the cyst and laying open
Intervention Type
Procedure
Intervention Name(s)
karydakis flap
Other Intervention Name(s)
lateralization, primary repair
Intervention Description
Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft
Intervention Type
Procedure
Intervention Name(s)
laying open
Intervention Description
laying open the site of excision of sinus or cyst without any flap
Primary Outcome Measure Information:
Title
Recurrence
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Work off date, Healing Time
Time Frame
up to 1 Year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all types of pilonidal sinus or cyst Exclusion Criteria: no exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Keshvari, Assoc. Prof.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of medical Sciences, Deputy of Research
City
Tehran
ZIP/Postal Code
23
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus

We'll reach out to this number within 24 hrs