A Trial in Mini-invasive Pilonidal Sinus Disease Surgery

NCT ID: NCT06964763

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2029-12-17

Brief Summary

Pilonidal sinus disease is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Advantages of mini-invasive techniques include: quicker recovery and earlier return to work and high patient satisfaction. Randomized studies are rare and this applies especially to newer mini-invasive techniques. The purpose of the investigators prospective study is to randomly compare the mini-invasive laser ablation technique to the mini-invasive fibrin glue treatment in pilonidal sinus disease surgery.

Detailed Description

This is a multicenter study comparing two mini-invasive treatmnet options in pilonidal sinus disease. The study is carried out in four hospitals in Uusimaa county of Finland (Jorvi hospital, Porvoo hospital, Lohja hospital and Hyvinkää hospital). Patients, who are 18 or above, with a symptomatic primary pilonidal sinus disease are eligible for the study. On the day of surgery, the patient is randomly assigned to one of the two surgery groups. The main variable of our study is the healing rate at 2 months after surgery. Other variables to be studied are: postoperative complications, length of sick leave, time for returning to everyday life, recurrence rate and the effects of PSD and PSD surgery on the patient's quality of life. A cost analysis will be performed. Risk factors such as overweight, pubic hair, smoking and associated diseases such as diabetes will also be analyzed. According to the power calculation, the investigators need 94 patients in each group to ensure the success of the study.

Conditions

Pilonidal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group 1

surgery + laser ablation

Group Type: ACTIVE_COMPARATOR

surgery + laser

Intervention Type: PROCEDURE

laser

study group 2

surgery + fibrine glue

Group Type: ACTIVE_COMPARATOR

surgery + fibrine glue

Intervention Type: PROCEDURE

fibrine glue

Interventions

surgery + laser

laser

Intervention Type: PROCEDURE

surgery + fibrine glue

fibrine glue

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• primary pilonidal sinus disease
• age 18 and above

Exclusion Criteria

• recurrent pilonidal sinus disease
• age under 18
• inability to understand Finnish or Swedish (the questionnaires are in Finnish and Swedish only, the two official languages of Finland)

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

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kethe Hermunen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pauli Puolakkainen, Professor

Role: STUDY_DIRECTOR

University of Helsinki, Department of Surgery

Locations

HUS Vatsakeskus Abdominal Center of Helsinki University Hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

HUS/2951/2021

Identifier Type: -

Identifier Source: org_study_id