Pilonidal SinusNCT04599517
The Most Frequently Preferred Surgical Method In The Treatment Of Sacrococcygeal Pilonidal Disease
An observational study of Pilonidal Sinus, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Pilonidal Sinus
- How many people
- 6,748 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2020to 15 Dec 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients aged 14-80 years who underwent surgery for pilonidal sinus constitute the study population.
Who may be able to join
- All patients between the ages of 14-80 who underwent surgery for pilonidal sinus
Who cannot join
- unregulated diabetes mellitus
- collagen tissue disease
- decompensated cardiovascular disease
- cases with missing follow-up information
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: The Most Frequently Preferred Surgical Method In The Treatment Of Sacrococcygeal Pilonidal Disease; Multicenter Cohort Study
There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most frequently used surgical treatment method and its results.
Read the detailed description
The researchers in our study will retrospectively scan the records of patients who have been operated on for SPD in the last 15 years at Health Sciences University Konya Health Practice and Research Center, Selçuk University Medical Faculty Hospital, Necmettin Erbakan University Medical Faculty Hospital, and Başkent University Medical Faculty Hospital General Surgery Clinics.
Demographic characteristics of the patients, type of anesthesia, duration of operation, duration of hospitalization, time to return to work or school, final healing time, follow-up time, and recurrence information will be transferred to the SPSS statistics program analyzed.
The researchers could not find any articles in the literature on the subject. Therefore, this study will contribute to the literature.
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal, surgery, healing
- Medical subject headings
- Pilonidal Sinus
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of surgery method
The ratio of each type of surgery to the study population
Measured: 15 day
duration of surgery
The average operation time of the determined types of surgery will be determined.
Measured: 15 day
hospitalization time
The average hospitalization time of the determined types of surgery will be determined.
Measured: 15 day
Type of anesthesia
the ratio of anesthesia methods to the study population
Measured: 15 day
day time return to work
return to work time will be found as average days for specified surgery types.
Measured: 15 days
complete healing time
Complete healing time will be found as average days for specified surgery types
Measured: 15 days
recurrence
recurrence rate in the study population
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Oct 2020
- Primary completion25 Nov 2020
- Study completion15 Dec 2020
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.
- 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
- 6,748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599517
- Sponsor's protocol ID
- HSU Konya HPRC General Surgery
- Status last verified
- Jan 2021
- First submitted
- 18 Oct 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to make individual participant data (IPD) available to other researchers
Publications
Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
PubMed 30640830Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. doi: 10.1016/s0039-6109(02)00062-2.
PubMed 12516846Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.
PubMed 29449548
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Most Frequently Preferred Surgical Method In The Treatment Of Sacrococcygeal Pilonidal Disease; Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04599517
- Acronym / sponsor ID
- HSU Konya HPRC General Surgery
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal, surgery, healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,748 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 22 Oct 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.
There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most frequently used surgical treatment method and its results.
Detailed description
The researchers in our study will retrospectively scan the records of patients who have been operated on for SPD in the last 15 years at Health Sciences University Konya Health Practice and Research Center, Selçuk University Medical Faculty Hospital, Necmettin Erbakan University Medical Faculty Hospital, and Başkent University Medical Faculty Hospital General Surgery Clinics.
Demographic characteristics of the patients, type of anesthesia, duration of operation, duration of hospitalization, time to return to work or school, final healing time, follow-up time, and recurrence information will be transferred to the SPSS statistics program analyzed.
The researchers could not find any articles in the literature on the subject. Therefore, this study will contribute to the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients aged 14-80 years who underwent surgery for pilonidal sinus constitute the study population.
Key inclusion criteria (1 listed)
- All patients between the ages of 14-80 who underwent surgery for pilonidal sinus
Key exclusion criteria (4 listed)
- unregulated diabetes mellitus
- collagen tissue disease
- decompensated cardiovascular disease
- cases with missing follow-up information
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
Type of surgery method
Time frame: 15 day
The ratio of each type of surgery to the study population
duration of surgery
Time frame: 15 day
The average operation time of the determined types of surgery will be determined.
hospitalization time
Time frame: 15 day
The average hospitalization time of the determined types of surgery will be determined.
Type of anesthesia
Time frame: 15 day
the ratio of anesthesia methods to the study population
day time return to work
Time frame: 15 days
return to work time will be found as average days for specified surgery types.
complete healing time
Time frame: 15 days
Complete healing time will be found as average days for specified surgery types
recurrence
Time frame: 15 days
recurrence rate in the study population
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 6 Jan 2021.
- Background: PubMed 30640830Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
- Background: PubMed 12516846Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. doi: 10.1016/s0039-6109(02)00062-2.
- Background: PubMed 29449548Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.
- Individual participant dataSharing planned: No. No plans to make individual participant data (IPD) available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Konya Meram State 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 4 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 6 Jan 2021. 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?
Type of surgery method (time frame: 15 day). The study lists 7 primary outcomes in all. 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 NCT04599517, 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 6 Jan 2021.