NCT05519033

Brief Summary

In this research, main purpose is to determine the recurrence prevalence. Destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. . Primary outcome; To determine the postoperative recurrence rates according to the type of surgical intervention. The secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,742

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 25, 2022

Last Update Submit

August 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Recurrence

    Determine the postoperative recurrence rates according to type of surgical intervention.

    12 months

Secondary Outcomes (1)

  • the ratio of different techniques methods

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ,with pilonidal sinus, treated by general surgeons

You may qualify if:

  • \- Symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician.

You may not qualify if:

  • Patients under 18 years of age asymptomatic (Stage I), acute abscess (Stage II), pregnant patients, presence of systemic disease such as DM, UC, Hidradenitis Suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

Study Officials

  • Sezai Leventoglu, Proffesor

    Gazi University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

March 1, 2021

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations