- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356768
Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
April 20, 2020 updated by: Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens, Retrospective Analysis of 1971 Resections.
Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus.
In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination.
Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; We think that routine pathological examination of the pilonidal sinus is unnecessary.
Study Overview
Status
Completed
Conditions
Detailed Description
Pilonidal sinus is a benign disease.
In the histopathological examination of pilonidal sinus specimens, malignancy can be detected rarely.
Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus.
In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination.
The investigators aimed to discuss the pathological findings of patients who were operated for pilonidal sinus in our clinic in light of the literature.
The fact that the rate of malignancy in the literature does not show parallelism with minimally invasive procedures that pathology samples are not taken and whose applications are increasing supports this prediction.
Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; the investigators think that routine pathological examination of the pilonidal sinus is unnecessary.
Study Type
Observational
Enrollment (Actual)
1971
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey
- Dr. Ersin Arslan Training and Resource Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were operated on for pilonidal sinus between January 2016 and March 2020 at our hospital.
Description
Inclusion Criteria:
- sacrococcygeal pilonidal sinus
Exclusion Criteria:
- non-sacrococcygeal pilonidal sinus
- minimally invasive treatment without histopathological examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidental cancer
Time Frame: 2 or 3 week
|
Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
|
2 or 3 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 17, 2020
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 22, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2020
Last Update Submitted That Met QC Criteria
April 20, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17042020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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