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

Primary Purpose

Pilonidal Sinus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilonidal sinus excision
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Pilonidal sinus, Methylene blue, Histopathology, Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif University, Faculty of Medicine, Department of Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylene Blue

Arm Description

The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.

Outcomes

Primary Outcome Measures

Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue

Secondary Outcome Measures

Full Information

First Posted
January 17, 2012
Last Updated
July 23, 2016
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT01513382
Brief Title
Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.
Acronym
BAVUGC-2
Official Title
Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Pilonidal sinus, Methylene blue, Histopathology, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylene Blue
Arm Type
Experimental
Arm Description
The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.
Intervention Type
Procedure
Intervention Name(s)
Pilonidal sinus excision
Intervention Description
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 Measure Information:
Title
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suleyman Bozkurt, M.D.
Organizational Affiliation
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erhan Aysan, Prof. Dr.
Organizational Affiliation
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
17960395
Citation
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.
Results Reference
result
PubMed Identifier
17703314
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. doi: 10.1007/s00384-007-0377-9. Epub 2007 Aug 17.
Results Reference
result
PubMed Identifier
19330243
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. doi: 10.1590/s1807-59322009000300007.
Results Reference
result

Learn more about this trial

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

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