PathologyNCT04356768
Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
An observational study of Pathology, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- How many people
- 1,971 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 17 Apr 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were operated on for pilonidal sinus between January 2016 and March 2020 at our hospital.
Who may be able to join
- sacrococcygeal pilonidal sinus
Who cannot join
- non-sacrococcygeal pilonidal sinus
- minimally invasive treatment without histopathological examination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Official title: 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.
Read the 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.
- Conditions
- Pathology
- Keywords
- Pilonidal sinus, carcinoma, pathology, squamous cell carcinoma, phenol
- Medical subject headings
- Pilonidal Sinus, Carcinoma, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidental cancer
Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
Measured: 2 or 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Mar 2020
- Primary completion1 Apr 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathologyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
- Investigators
- Ufuk Uylas, Specialist, Principal investigator, Dr. Ersin Arslan Training and Resource Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356768
- Sponsor's protocol ID
- 17042020
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens, Retrospective Analysis of 1971 Resections.
- ClinicalTrials.gov ID
- NCT04356768
- Acronym / sponsor ID
- 17042020
- Conditions
- Pathology
- Keywords
- Pilonidal sinus, carcinoma, pathology, squamous cell carcinoma, phenol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,971 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were operated on for pilonidal sinus between January 2016 and March 2020 at our hospital.
Key inclusion criteria (1 listed)
- sacrococcygeal pilonidal sinus
Key exclusion criteria (2 listed)
- non-sacrococcygeal pilonidal sinus
- minimally invasive treatment without histopathological examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidental cancer
Time frame: 2 or 3 week
Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
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 22 Apr 2020.
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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.
Ufuk Uylas, Specialist principal investigator
Dr. Ersin Arslan Training and Resource Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathology, run by Dr. Ersin Arslan Education and Training Hospital 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 1 inclusion and 2 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 22 Apr 2020. 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?
Incidental cancer (time frame: 2 or 3 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2020.