NCT04356768

Brief Summary

Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; We think that routine pathological examination of the pilonidal sinus is unnecessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,971

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 17, 2020

Last Update Submit

April 20, 2020

Conditions

Pathology

Keywords

Pilonidal sinuscarcinomapathologysquamous cell carcinomaphenol

Outcome Measures

Primary Outcomes (1)

  • Incidental cancer

    Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens

    2 or 3 week

Eligibility Criteria

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

Patients who were operated on for pilonidal sinus between January 2016 and March 2020 at our hospital.

You may qualify if:

  • sacrococcygeal pilonidal sinus

You may not qualify if:

  • non-sacrococcygeal pilonidal sinus
  • minimally invasive treatment without histopathological examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ersin Arslan Training and Resource Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pilonidal SinusCarcinomaCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CystsNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Ufuk Uylas, Specialist

    Dr. Ersin Arslan Training and Resource Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 22, 2020

Study Start

March 1, 2020

Primary Completion

April 1, 2020

Study Completion

April 17, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations

TU(1)