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Enrolling by Invitation

NCT Number: NCT06964763

A Trial in Mini-invasive Pilonidal Sinus Disease Surgery

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.

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Key information

Conditions

Pilonidal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS Vatsakeskus Abdominal Center of Helsinki University Hospital

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

surgery + laser

Procedure

laser

surgery + fibrine glue

Procedure

fibrine glue

Primary outcomes

  1. Healing rate

    Time frame: 2 months after surgery

    Healing rate will be assessed by a questionnaire and a phone call

  2. Quality of life

    Time frame: 2 months after surgery

    Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey

Secondary outcomes

  1. Recurrence rate

    Time frame: 1, 3 and 5 years after surgery

    Follow-up at 1, 3 and 5 years by assessing electronic medical records to reveal recurrences

  2. Cost analysis

    Time frame: At 2 months after surgery

    Compare the price for the two surgical treatments

  3. Postoperative complications

    Time frame: 2 - 3 months after the surgery

    Postoperative complications will be assessed by a phone call and clinical examination

  4. Sick leave

    Time frame: 2 months and 1 year after surgery

    Length of sick leave will be assessed by a questionnaire and medical records

  5. Recovery time

    Time frame: 2 months and 1 year after surgery

    The time it has taken fot the patient to return to everyday life is assessed by a questionnaire and through medical records

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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