Pilonidal Sinus TreatmentPiSiNCT05519033
Pilonidal Sinus-Turkey
An observational study of Pilonidal Sinus Treatment, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Treatment
- How many people
- 1,742 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 10 Jun 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients ,with pilonidal sinus, treated by general surgeons
Who may be able to join
- Symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician.
Who cannot join
- Patients under 18 years of age asymptomatic (Stage I), acute abscess (Stage II), pregnant patients, presence of systemic disease such as DM, UC, Hidradenitis Suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilondal Sinus Study: A National Survey
In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. .
Primary outcome; To determine the postoperative recurrence rates according to the type of surgical intervention.
The secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.
Read the detailed description
In this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. The treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. Before collecting any patient data, the Lead Investigator or authorized research team member must be verified as suitable for the study.
Information should be processed on the Case Report Form (CRF) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. Collected participant data will be recorded in the relevant CRFs and patient questionnaires. You should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . As a result; Since all patients who were operated between January 2019 and January 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. Later, the data will be transferred and entered into RedCAP, a remote web-based data collection system.
In CRF, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned.
- Conditions
- Pilonidal Sinus Treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Recurrence
Determine the postoperative recurrence rates according to type of surgical intervention.
Measured: 12 months
Secondary outcomes (1)
the ratio of different techniques methods
Compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Mar 2021
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus TreatmentStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Oncology Research and Training Hospital
- Responsible party
- Principal investigator, Ali Yalcinkaya, Gazi University
- Investigators
- Sezai Leventoglu, Proffesor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519033
- Sponsor's protocol ID
- PISI-TR
- Acronym
- PiSi
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 29 Aug 2022
- 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 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilondal Sinus Study: A National Survey
- ClinicalTrials.gov ID
- NCT05519033
- Acronym / sponsor ID
- PiSi / PISI-TR
- Conditions
- Pilonidal Sinus Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,742 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Oncology Research and Training Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 29 Aug 2022 (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.
In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. .
Primary outcome; To determine the postoperative recurrence rates according to the type of surgical intervention.
The secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.
Detailed description
In this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. The treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. Before collecting any patient data, the Lead Investigator or authorized research team member must be verified as suitable for the study.
Information should be processed on the Case Report Form (CRF) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. Collected participant data will be recorded in the relevant CRFs and patient questionnaires. You should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . As a result; Since all patients who were operated between January 2019 and January 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. Later, the data will be transferred and entered into RedCAP, a remote web-based data collection system.
In CRF, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients ,with pilonidal sinus, treated by general surgeons
Key inclusion criteria (1 listed)
- Symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician.
Key exclusion criteria (1 listed)
- Patients under 18 years of age asymptomatic (Stage I), acute abscess (Stage II), pregnant patients, presence of systemic disease such as DM, UC, Hidradenitis Suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.
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
Postoperative Recurrence
Time frame: 12 months
Determine the postoperative recurrence rates according to type of surgical intervention.
1 secondary outcome
the ratio of different techniques methods
Time frame: 12 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 29 Aug 2022.
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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.
Sezai Leventoglu, Proffesor study chair
Gazi University
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 Pilonidal Sinus Treatment, run by Gazi 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 1 inclusion and 1 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 29 Aug 2022. 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?
Postoperative Recurrence (time frame: 12 months). 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 29 Aug 2022.