Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.
BAVUGC-2
Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
1 other identifier
interventional
30
1 country
1
Brief Summary
Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 26, 2016
July 1, 2016
2 months
January 17, 2012
July 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
3 months
Study Arms (1)
Methylene Blue
EXPERIMENTALThe effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pilonidal sinus disease of the intergluteal region
- Primary disease without history of drainage
- Ages between 18 and 65, both gender
You may not qualify if:
- Recurrent pilonidal sinus disease
- Acute infection with abscess formation and/or purulent copious drainage
- Denial to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Istanbul, 34093, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 17960395RESULTSoll 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.
PMID: 17703314RESULTMentes 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.
PMID: 19330243RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suleyman Bozkurt, M.D.
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
- STUDY DIRECTOR
Erhan Aysan, Prof. Dr.
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 20, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 26, 2016
Record last verified: 2016-07