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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group 1 | Active Comparator | surgery + laser ablation |
|
| study group 2 | Active Comparator | surgery + fibrine glue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery + laser | Procedure | laser |
| |
| surgery + fibrine glue |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauli Puolakkainen, Professor | University of Helsinki, Department of Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS Vatsakeskus Abdominal Center of Helsinki University Hospital | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42288936 | Derived | 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. |
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We have not yet discussed this within the study group
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Procedure |
fibrine glue |
|
| 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 |