Comparison of Bascom Cleft Lift Technique Versus Limberg Flap Closure for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Controlled Trial Evaluating for Patient Satisfaction and Early Recurrence
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Pilonidal Sinus
Both
Pilonidal Sinus
Trial Information
Comparison of Bascom Cleft Lift Technique Versus Limberg Flap Closure for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Controlled Trial Evaluating for Patient Satisfaction and Early Recurrence
Inclusion Criteria:
- All types of pilonidal sinus or cyst
- The patient understands trial information and is capable of making a decision for
informed consent after having received information.
- The patient wants to undergo surgery for pilonidal sinus and accepts participation in
the trial.
Exclusion Criteria:
- acute abscess formation (Cruse-Foord Class IV)
- patient with minor inflammation are included to trial after two-week antibiotic
treatment (Cruse-Foord Class III)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Quality of life and postoperative pain
Outcome Description:
Determine patient satisfaction factors using the quality of life survey (SF-36 form) on the 10th-30th day and postoperative pain by using post-operative visual analog pain scale on the 2nd-10th day
Outcome Time Frame:
within 30 days
Safety Issue:
No
Authority:
Turkey: Ministry of Health
Study ID:
TNEAH-2010GC1
NCT ID:
NCT01337869
Start Date:
January 2011
Completion Date:
December 2011
Related Keywords:
- Pilonidal Sinus
- Bascom Procedure, Limberg, Pilonidal Disease
- Pilonidal Sinus
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