Pilonidal Sinus-Turkey (PiSi)

Pilondal Sinus Study: A National Survey

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus Treatment

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.

• Study Type: Observational
• Enrollment (Actual): 1742

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients ,with pilonidal sinus, treated by general surgeons

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Recurrence	Determine the postoperative recurrence rates according to type of surgical intervention.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the ratio of different techniques methods	Compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.	12 months

Collaborators and Investigators

• Sponsor: Gazi University
• Collaborators: Ankara Oncology Research and Training Hospital; Ankara Diskapi Yildirim Beyazit Training and Research Hospital
• Investigators: Study Chair: Sezai Leventoğlu, Proffesor, Gazi University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): June 10, 2021
• Study Completion (ACTUAL): June 10, 2021

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (ACTUAL): August 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: PISI-TR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No