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CompletedNCT04856605Updated Mar 6, 2024

Umblical Pilonidal Sinus Evaluation

An observational study in Pilonidal Sinus, sponsored by Istanbul Medeniyet University. Completed. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Istanbul Medeniyet University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
82
Ages
15 Years to 80 Years
Sex
All
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Study summary

Purpose: Pilonidal sinus disease (PSD) is a chronic inflammatory condition of skin due to implanted loose hair. PSD is commonly seen in sacrococcygeal region, but can also be seen in axilla, perineum, suprapubic regions, on hands and umbilicus. The aim of this project was to find factors influencing the development and treatment of umbilical pilonidal sinus.

Material and methods: In this cross-sectional prospective study, the investigators evaulated 82 (19 female, 63 male) patients with a history of umbilical pilonidal disease (e.g. predisposing factors, treatment modalities) between 2012 and 2020.

Read the detailed description

In this study, participants were volunteer patients admitted to Erzincan University Medical Faculty to the General Surgery Outpatient Clinic between March of 2012 and December of 2020 with umbilical symptoms such as umbilical discharge and umbilical pain. All patients were diagnosed by physical examination confirmed with ultrasonography . Patients with diseases other than umbilical sinus were excluded from the study. Examined patients' characteristics include age, gender, intergluteal sinus disease history, family history, belly shaving histoy, daily shower, treatment modality and healing status. There were 3 treatment modalities: conservative approach (daily shower, shaving, antibitics if infected); topical silver nitrate treatment; surgical operation for umbilical sinus as excracting the hairs from the sinus ± excising the sinus. To determine if "healed" the investigators followed up our patients ensuring no symptoms for a minimum 2 years.

Chi-square tests were conducted to compare the distribution of categorical variables. Age was analyzed as a continuous variable with a t-test. Univariable and multivariable logistic regression models were used to calculate odds ratios and 95% confidence intervals. P-values of less than 0.05 were considered statistically significant. Statistical analyses were conducted with R version of 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria, https://www.r-project.org) software packages.

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Conditions studied

  • Pilonidal Sinus

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03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 82 is below the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients who have umblical pilonidal disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients with umblical pilonidal sinus

Exclusion criteria

Exclusion Criteria:

  • no disease
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
82 participants (actual)
Target follow-up
8 Years
Patient registry
Yes

Interventions

  • Proceduresurgery

    regular surgery

06

What researchers measure

Primary outcomes

  1. healing status

    to define the best method for healing. It will be measured by the duration(days) of healing.

    Time frame: 2 year

Secondary outcomes

  1. recurrence status

    to define the best method for recurrence prevention. Recurrence will be noted as purulent discharge over the umblicus.

    Time frame: 2 year

Other outcomes

  1. duration of wound healing

    The investigators will measure the diameter(cm) of the wound everyday.

    Time frame: 2 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2012 to primary completion in Dec 2020, 107 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2021
First posted
Apr 23, 2021
StartActual
Jan 1, 2012
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Mar 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04856605
Responsible party
Arda Isik, MD, FEBS, FACS (assoc.prof., Istanbul Medeniyet University) — Principal investigator
First posted
Apr 23, 2021
Start date
Jan 1, 2012
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Mar 6, 2024

Study contacts

ARDA ISIK
principal investigator · MEDENIYET UNIVERSITY

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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