A Trial in Mini-invasive Pilonidal Sinus Disease Surgery

Not Applicable

• Conditions: Pilonidal Disease

• Registration Number: NCT06964763
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2029-06-17
• Study Completion: 2029-12-17

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 188

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Healing rate	2 months after surgery	Healing rate will be assessed by a questionnaire and a phone call
Quality of life	2 months after surgery	Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey

Secondary Outcome Measures

Name	Time	Method
Sick leave	2 months and 1 year after surgery	Length of sick leave will be assessed by a questionnaire and medical records
Recurrence rate	1, 3 and 5 years after surgery	Follow-up at 1, 3 and 5 years by assessing electronic medical records to reveal recurrences
Cost analysis	At 2 months after surgery	Compare the price for the two surgical treatments
Postoperative complications	2 - 3 months after the surgery	Postoperative complications will be assessed by a phone call and clinical examination
Recovery time	2 months and 1 year after surgery	The time it has taken fot the patient to return to everyday life is assessed by a questionnaire and through medical records

Trial Locations

Locations (1)

HUS Vatsakeskus Abdominal Center of Helsinki University Hospital; 🇫🇮 Helsinki, Finland