Karydakis Procedure Versus Laying-Open in Sacrococcygeal Pilonidal Sinus - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00716937

Purpose

Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Laying-open Technique in Imam Khomeini Hospital from 2008 to 2011

Condition	Intervention	Phase
Pilonidal Sinus Pilonidal Cyst	Procedure: karydakis flap Procedure: laying open	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Recurrence, Complications, Work-Off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Laying-Open Technique in Imam Khomeini Hospital From 1386 to 1389

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

Reoccurrence [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Work off date, Healing Time [ Time Frame: up to 1 Year after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	284
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental Excision of the cyst and laying open	Procedure: laying open laying open the site of excision of sinus or cyst without any flap

Eligibility

Ages Eligible for Study:	10 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716937

Contacts

Contact: Amir Keshvari, Dr.

00982166937185

keshvari@tums.ac.ir

Locations

Iran, Islamic Republic of
Tehran University of medical Sciences, Deputy of Research	Recruiting
Tehran, Iran, Islamic Republic of, 23

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair:

Amir Keshvari, assitant professor

Tehran Uniyersity of Medical Sciences

More Information

Responsible Party:	Tehran university of medical sciences ( Dr. fotoohi - Vice chancellor for reaserch )
Study ID Numbers:	6148, 6148
Study First Received:	July 14, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00716937
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

pilonidal sinus
karidakis
laying open

Study placed in the following topic categories:

Pilonidal Sinus
Cysts
Recurrence

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009