A Trial in Mini-invasive Pilonidal Sinus Disease Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура surgery + laser
  laser
• Процедура surgery + fibrine glue
  fibrine glue

Первичные конечные точки

• Healing rate [Срок оценки: 2 months after surgery]
• Quality of life [Срок оценки: 2 months after surgery]

Вторичные конечные точки (5)

• Recurrence rate [Срок оценки: 1, 3 and 5 years after surgery]
• Cost analysis [Срок оценки: At 2 months after surgery]
• Postoperative complications [Срок оценки: 2 - 3 months after the surgery]
• Sick leave [Срок оценки: 2 months and 1 year after surgery]
• Recovery time [Срок оценки: 2 months and 1 year after surgery]

Критерии участия

Критерии включения

• primary pilonidal sinus disease
• age 18 and above

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• HUS Vatsakeskus Abdominal Center of Helsinki University Hospital — Helsinki

Публикации

• 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

Идентификаторы

NCT: NCT06964763 · HUS/2951/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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