Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure. — SI-BAS  

Pilonidal Disease Clinical Trial

Official title: Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom

Status Active, not recruiting

Clinical Trial Summary

Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.

Clinical Trial Description

Pilonidal sinus disease (PSD): is 26 cases per 100,000 population, affects primarily young adults. One of the problems of surgical treatment of PSD is the frequent development of recurrence. There are various methods of surgical treatment, but the recurrence rate still high up to 67%. Nowadays, minimally invasive methods for PSD (e.g. the use of a diode laser for sinus obliteration- SiLac, Sinus Laser Closure) compete with traditional methods. This "day-surgery" method significantly reduces the risk of postoperative complications, allows a quicker return to normal daily activity, preserves the intergluteal cleft and provides the best cosmetic results. According to some authors, the recurrence rate in this method is up to 26%, parallel others- recurrence rate is less 3 %, but the follow-up does not exceed 2 years. On the other hand, the excision of the PSD with the mobilization of the skin-subcutaneous flap, which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate (up to 4%) . Thus, despite the increased use of minimally invasive surgery, excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies. ;

Related Conditions & MeSH terms

• Paranasal Sinus Diseases
• Pilonidal Disease
• Pilonidal Sinus

• NCT number: NCT05715983
• Study type: Interventional
• Source: Russian Society of Colorectal Surgeons
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2022
• Completion date: January 31, 2025