A Trial in Mini-invasive Pilonidal Sinus Disease Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery + laser, surgery + fibrine glue.
- Who it may be relevant to
- Registry conditions: Pilonidal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Procedure surgery + laser
laser - Procedure surgery + fibrine glue
fibrine glue
Primary outcome measures
- Healing rate [Time frame: 2 months after surgery]
- Quality of life [Time frame: 2 months after surgery]
Secondary outcome measures (5)
- Recurrence rate [Time frame: 1, 3 and 5 years after surgery]
- Cost analysis [Time frame: At 2 months after surgery]
- Postoperative complications [Time frame: 2 - 3 months after the surgery]
- Sick leave [Time frame: 2 months and 1 year after surgery]
- Recovery time [Time frame: 2 months and 1 year after surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- HUS Vatsakeskus Abdominal Center of Helsinki University Hospital — Helsinki
Publications
- Koskinen K, Koppatz H, Poussa T, Harju J, Hermunen K. Glue versus Laser Ablation in Mini-invasive Pilonidal sinus surgery-the GLAMP study: a study protocol for a randomised controlled trial. Trials. 2026 Jun 13. doi: 10.1186/s13063-026-09852-8. Online ahead of print. PMID 42288936
Identifiers
NCT: NCT06964763 · HUS/2951/2021