A Trial in Mini-invasive Pilonidal Sinus Disease Surgery

Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pilonidal Disease
• Intervention / Treatment: Procedure: surgery + laser; Procedure: surgery + fibrine glue

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 Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • HUS Vatsakeskus Abdominal Center of Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group 1; surgery + laser ablation	Procedure: surgery + laser; laser
Active Comparator: study group 2; surgery + fibrine glue	Procedure: surgery + fibrine glue; fibrine glue

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Pauli Puolakkainen, Professor, University of Helsinki, Department of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): June 17, 2029
• Study Completion (Estimated): December 17, 2029

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: randomized trial; prospective study; laser ablation; pilonidal sinus disease; fibrine glue
• Additional Relevant MeSH Terms: Neoplasms; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Cysts; Paranasal Sinus Diseases; Pilonidal Sinus
• Other Study ID Numbers: HUS/2951/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not yet discussed this within the study group

Drug and device information, study documents

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