Clinical trial NCT06964763: A Trial in Mini-invasive Pilonidal Sinus Disease Surgery
Official title: Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pilonidal Disease
Keywords: pilonidal sinus disease
laser ablation
fibrine glue
randomized trial
prospective study
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Healing rate
timeFrame: 2 months after surgery
measure: Quality of life
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Recurrence rate
timeFrame: 1, 3 and 5 years after surgery
measure: Cost analysis
timeFrame: At 2 months after surgery
measure: Postoperative complications
timeFrame: 2 - 3 months after the surgery
measure: Sick leave
timeFrame: 2 months and 1 year after surgery
measure: Recovery time
timeFrame: 2 months and 1 year after surgery
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Vatsakeskus Abdominal Center of Helsinki University Hospital
Study officials:
affiliation: University of Helsinki, Department of Surgery
name: Pauli Puolakkainen, Professor
role: STUDY_DIRECTOR
References: