NCT04856605

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

9 years

First QC Date

April 14, 2021

Last Update Submit

March 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • healing status

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

    2 year

Secondary Outcomes (1)

  • recurrence status

    2 year

Other Outcomes (1)

  • duration of wound healing

    2 year

Interventions

surgeryPROCEDURE

regular surgery

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who have umblical pilonidal disease

You may qualify if:

  • all patients with umblical pilonidal sinus

You may not qualify if:

  • no disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • ARDA ISIK

    MEDENIYET UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof.

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 23, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share