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

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ClinicalTrials.gov Identifier: NCT00716937
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

July 14, 2008
July 16, 2008
December 16, 2014
September 2007
March 2014   (Final data collection date for primary outcome measure)
Recurrence [ Time Frame: 1 year after surgery ]
Reoccurrence [ Time Frame: 1 year after surgery ]
Complete list of historical versions of study NCT00716937 on ClinicalTrials.gov Archive Site
Work off date, Healing Time [ Time Frame: up to 1 Year after surgery ]
Same as current
Not Provided
Not Provided
 
Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pilonidal Sinus
  • Pilonidal Cyst
  • 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
  • Experimental: 1
    Excision of the cyst and Karydakis flap
    Intervention: Procedure: karydakis flap
  • Experimental: 2
    Excision of the cyst and laying open
    Interventions:
    • Procedure: karydakis flap
    • Procedure: laying open
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
284
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

Sexes Eligible for Study: All
10 Years to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00716937
6148
86-04-30-6148 ( Other Identifier: Tehran University of Medical Sciences )
Yes
Not Provided
Not Provided
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Amir Keshvari, Assoc. Prof. Tehran University of Medical Sciences
Tehran University of Medical Sciences
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP