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Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus. (BAVUGC-2)

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ClinicalTrials.gov Identifier: NCT01513382
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Suleyman Bozkurt, Bezmialem Vakif University

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

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: Pilonidal sinus excision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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




Primary Outcome Measures :
  1. Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513382


Locations
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Turkey
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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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

Publications of Results:
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Responsible Party: Suleyman Bozkurt, Medical Doctor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01513382     History of Changes
Other Study ID Numbers: BAVUGC-2
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Suleyman Bozkurt, Bezmialem Vakif University:
Pilonidal sinus
Methylene blue
Histopathology
Surgery
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action