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

Pilonidal Sinus Clinical Trial

— BAVUGC-2  

Official title:

Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513382
• Other study ID #: BAVUGC-2
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: July 23, 2016
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: July 2016
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University, Faculty of Medicine, Department of Surgery	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Doll D, Novotny A, Rothe R, Kristiansen JE, Wietelmann K, Boulesteix AL, Düsel 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. Epub 2007 Oct 25. — View Citation

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. — View Citation

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. Epub 2007 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue		3 months	Yes