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OpenTrials
Completed

NCT Number: NCT05519033

Pilonidal Sinus-Turkey

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative Recurrence

    Time frame: 12 months

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

Secondary outcomes

  1. the ratio of different techniques methods

    Time frame: 12 months

    Compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in Turkey.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Ankara Oncology Research and Training Hospital
  • Diskapi Yildirim Beyazit Education and Research Hospital

Registry information

Official study title

Pilondal Sinus Study: A National Survey

Acronym: PiSi

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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