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

NCT ID: NCT01513382

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pilonidal Sinus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methylene Blue

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

Group Type EXPERIMENTAL

Pilonidal sinus excision

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suleyman Bozkurt

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suleyman Bozkurt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University, Faculty of Medicine, Department of Surgery

Erhan Aysan, Prof. Dr.

Role: STUDY_DIRECTOR

Bezmialem Vakif University, Faculty of Medicine, Department of Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem Vakif University, Faculty of Medicine, Department of Surgery

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17960395 (View on PubMed)

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.

Reference Type RESULT
PMID: 17703314 (View on PubMed)

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.

Reference Type RESULT
PMID: 19330243 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BAVUGC-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pilonidal Sinus Disease
NCT06508086 RECRUITING NA
Laser and Phenol Treatment for Pilonidal Sinus
NCT07022899 ACTIVE_NOT_RECRUITING