Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.

Overview

Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.

Full Title of Study: “Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Detailed Description

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.

Interventions

  • Procedure: Pilonidal sinus excision
    • The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.

Arms, Groups and Cohorts

  • Experimental: Methylene Blue
    • The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.

Clinical Trial Outcome Measures

Primary Measures

  • Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
    • Time Frame: 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Suleyman Bozkurt, Medical Doctor – Bezmialem Vakif University
  • Overall Official(s)
    • Suleyman Bozkurt, M.D., Principal Investigator, Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
    • Erhan Aysan, Prof. Dr., Study Director, Bezmialem Vakif University, Faculty of Medicine, Department of Surgery

Citations Reporting on Results

Doll D, Novotny A, Rothe R, Kristiansen JE, Wietelmann K, Boulesteix AL, Dusel W, Petersen S. Methylene Blue halves the long-term recurrence rate in acute pilonidal sinus disease. Int J Colorectal Dis. 2008 Feb;23(2):181-7. doi: 10.1007/s00384-007-0393-9. Epub 2007 Oct 25.

Soll C, Hahnloser D, Dindo D, Clavien PA, Hetzer F. A novel approach for treatment of sacrococcygeal pilonidal sinus: less is more. Int J Colorectal Dis. 2008 Feb;23(2):177-80. doi: 10.1007/s00384-007-0377-9. Epub 2007 Aug 17.

Mentes O, Oysul A, Harlak A, Zeybek N, Kozak O, Tufan T. Ultrasonography accurately evaluates the dimension and shape of the pilonidal sinus. Clinics (Sao Paulo). 2009;64(3):189-92. doi: 10.1590/s1807-59322009000300007.

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