Laser Ablation vs Fibrin Glue for Pilonidal Sinus Disease
surgery + laser
+ surgery + fibrine glue
Treatment Study
Summary
Study start date: September 1, 2023
Actual date on which the first participant was enrolled.This study is examining two minimally invasive treatment methods for pilonidal sinus disease, a condition where a painful cyst or abscess forms near the tailbone. The research takes place across four hospitals in Finland and involves adults aged 18 and older who have symptoms of this disease. The aim is to find out which treatment, either laser ablation or fibrin glue, is more effective in healing the condition. This research is important because it could lead to better treatment options, quicker recovery times, and improved quality of life for those affected by this uncomfortable condition. Participants in the study are randomly assigned to receive either laser ablation or fibrin glue treatment on the day of their surgery. Researchers then assess the healing progress two months after the surgery. They also track other factors like any postoperative complications, how long patients need to take off work, the time it takes to resume their usual activities, and how often the condition returns. Additionally, they analyze how these treatments and the disease itself impact the patients' quality of life. The study also considers risk factors such as obesity, body hair, smoking habits, and related health issues like diabetes. By involving 94 patients in each treatment group, the study aims to gather enough information to determine the best treatment approach.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.188 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
HUS Vatsakeskus Abdominal Center of Helsinki University Hospital
Helsinki, FinlandOpen HUS Vatsakeskus Abdominal Center of Helsinki University Hospital in Google Maps