Pilonidal SinusBAVUGC-2NCT01513382
Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.
A study testing Pilonidal sinus excision in people with Pilonidal Sinus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Pilonidal sinus excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pilonidal sinus disease of the intergluteal region
- Primary disease without history of drainage
- Ages between 18 and 65, both gender
Who cannot join
- Recurrent pilonidal sinus disease
- Acute infection with abscess formation and/or purulent copious drainage
- Denial to sign informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Istanbul, 34093
About this study
Official title: Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.
Read the 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.
- Conditions
- Pilonidal Sinus
- Being tested
- Pilonidal sinus excision
- Keywords
- Pilonidal sinus, Methylene blue, Histopathology, Surgery
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilonidal sinus excisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically. Receives: Procedure: Pilonidal sinus excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Bozkurt, Bezmialem Vakif University
- Investigators
- Suleyman Bozkurt, M.D., Principal investigator, Bezmialem Vakif University, Faculty of Medicine, Department of SurgeryErhan Aysan, Prof. Dr., Study director, Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513382
- Sponsor's protocol ID
- BAVUGC-2
- Acronym
- BAVUGC-2
- Status last verified
- Jul 2016
- First submitted
- 17 Jan 2012
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17960395Soll 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.
PubMed 17703314Mentes 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.
PubMed 19330243
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
- ClinicalTrials.gov ID
- NCT01513382
- Acronym / sponsor ID
- BAVUGC-2 / BAVUGC-2
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, Methylene blue, Histopathology, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue | Experimental | Procedure: Pilonidal sinus excisionThe effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pilonidal sinus disease of the intergluteal region
- Primary disease without history of drainage
- Ages between 18 and 65, both gender
Key exclusion criteria (3 listed)
- Recurrent pilonidal sinus disease
- Acute infection with abscess formation and/or purulent copious drainage
- Denial to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilonidal sinus excisionThe dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus. | Procedure or surgery | Methylene Blue |
Primary outcome
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Results publication: PubMed 17960395Doll 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 publication: PubMed 17703314Soll 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 publication: PubMed 19330243Mentes 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilonidal sinus excision in people with Pilonidal Sinus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.