Glue versus Laser Ablation in Mini-invasive Pilonidal sinus surgery-the GLAMP study: a study protocol for a randomised controlled trial
Abstract
Background: Pilonidal sinus disease (PSD) is a chronic acquired condition leading to significant morbidity and healthcare costs in the working-age population. Randomised studies of PSD surgery are rare, and this applies especially to newer mini-invasive techniques. The purpose of our study is to compare two mini-invasive techniques in PSD surgery: laser ablation and fibrin glue treatment.
Methods: This randomised, prospective, multicentre superiority non-blinded study compares two parallel groups of PSD patients treated with laser ablation and fibrin glue. It compares the outcome of these mini-invasive treatment options in regards to both short-term outcome (healing rate) and long-term outcome (recurrence rate), and to the cost of these two treatment options. On the day of surgery, if the operating surgeon indicates that a patient is suitable for laser ablation and glue treatment, that patient is randomly assigned to one of those two surgery groups. After the operation, the operating surgeon completes the examination form. Patients are asked to complete a quality-of-life questionnaire (RAND-36/SF-36) preoperatively and 2 months after surgery. Further, at 2 months, patients also complete an additional questionnaire regarding any discomfort, symptoms, and recovery. All statistical analyses are performed by means of standard statistical software such as SPSS and NCSS.
Discussion: In PSD surgery, very few prospective randomised trials exist, which makes it difficult to compare…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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