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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00716937
First received: July 14, 2008
Last updated: December 15, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention Phase
Pilonidal Sinus
Pilonidal Cyst
Procedure: karydakis flap
Procedure: laying open
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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

Primary Outcome Measures:
  • Recurrence [ 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 ]

Enrollment: 321
Study Start Date: September 2007
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • karydakis flap
  • 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:
  • karydakis flap
  • lateralization
  • primary repair
Procedure: laying open
laying open the site of excision of sinus or cyst without any flap
Other Name: laying open

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Iran, Islamic Republic of
Tehran University of medical Sciences, Deputy of Research
Tehran, Iran, Islamic Republic of, 23
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Amir Keshvari, Assoc. Prof. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00716937     History of Changes
Other Study ID Numbers: 6148, 86-04-30-6148
Study First Received: July 14, 2008
Last Updated: December 15, 2014
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
pilonidal sinus
karydakis
laying open

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on May 26, 2015