Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
18 Years
65 Years
Both
Pilonidal Sinus
Trial Information
Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
To study the potential benefits of intraoperative methylene blue use in pilonidal sinus
surgery in detecting the borders of the disease, the histopathologic correlation between the
specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene
blue was investigated. The branches that distinctly exceeded the planned dyed excision
borders will tried to be detected histopathologically, if any.
Inclusion Criteria:
- Pilonidal sinus disease of the intergluteal region
- Primary disease without history of drainage
- Ages between 18 and 65, both gender
Exclusion Criteria:
- Recurrent pilonidal sinus disease
- Acute infection with abscess formation and/or purulent copious drainage
- Denial to sign informed consent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Suleyman Bozkurt, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Authority:
Turkey: Ministry of Health
Study ID:
BAVUGC-2
NCT ID:
NCT01513382
Start Date:
January 2012
Completion Date:
March 2012
Related Keywords:
- Pilonidal Sinus
- Pilonidal sinus
- Methylene blue
- Histopathology
- Surgery
- Pilonidal Sinus
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