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

December 15, 2014 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

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

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Excision of the cyst and Karydakis flap
Procedure: karydakis flap
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
Other Names:
  • lateralization
  • primary repair
Experimental: 2
Excision of the cyst and laying open
Procedure: karydakis flap
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
Other Names:
  • lateralization
  • primary repair
Procedure: laying open
laying open the site of excision of sinus or cyst without any flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence
Time Frame: 1 year after surgery
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Work off date, Healing Time
Time Frame: up to 1 Year after surgery
up to 1 Year after surgery

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Amir Keshvari, Assoc. Prof., Tehran University of Medical Sciences

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

September 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6148
  • 86-04-30-6148 (Other Identifier: Tehran University of Medical Sciences)

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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