Umblical Pilonidal Sinus Evaluation

Pilonidal Sinus Clinical Trial

Official title:

The Factors Associated With Occurrence and Healing Of Umbilical Pilonidal Sinus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856605
• Other study ID #: umblicalps
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2024
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients with umblical pilonidal sinus

Exclusion Criteria:

• no disease

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• surgery
regular surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of wound healing	The investigators will measure the diameter(cm) of the wound everyday.	2 year
Primary	healing status	to define the best method for healing. It will be measured by the duration(days) of healing.	2 year
Secondary	recurrence status	to define the best method for recurrence prevention. Recurrence will be noted as purulent discharge over the umblicus.	2 year