Pilonidal Sinus-Turkey

NCT ID: NCT05519033

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1742 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-06-10

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.

Detailed Description

In this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. The treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. Before collecting any patient data, the Lead Investigator or authorized research team member must be verified as suitable for the study.

Information should be processed on the Case Report Form (CRF) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. Collected participant data will be recorded in the relevant CRFs and patient questionnaires. You should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . As a result; Since all patients who were operated between January 2019 and January 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. Later, the data will be transferred and entered into RedCAP, a remote web-based data collection system.

In CRF, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned.

Conditions

Pilonidal Sinus Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Diskapi Yildirim Beyazit Training and Research Hospital

UNKNOWN

Sponsor Role: collaborator

Ankara Oncology Research and Training Hospital

NETWORK

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ali Yalcinkaya

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezai Leventoglu, Proffesor

Role: STUDY_CHAIR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PISI-TR

Identifier Type: -

Identifier Source: org_study_id