NCT05715983

Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Russian Society of Colorectal Surgeons · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pilonidal Disease

Interventions

Type	Name	Description
PROCEDURE	Bascom II procedure	Buttocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide was injected in all orifices to visualize all tracts and sinuses. The proposal area of incision is marked nearby sinus tract openings and the skin with lateralization on one side of the cleft. A vertical-orientated incision of the skin and subcutaneous fat around the primary and secondary orifices is made using a scalpel or a monopolar electrocautery. The sinus tract is excised in en-block till unchanged subcutaneous tissue. The wound is irrigated with antiseptic solution. If postoperative wound is larger than 5 cm then a silicone draining tube is placed through the contraperature in the upper corner. The wound is closed by interrupted sutures Vicryl/Polysorb 2/0 3/0 layer by layer. Aseptic dressing is applied to the closed wound.
PROCEDURE	SiLaC	Buttocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide is injected in all orifices to visualize all tracts and sinuses. All visible orifices are excised with a scalpel or dermo punch. After that hairs are removed from the sinus by Volkmann curette. A metallic stylet is used to determine the length and direction of the different tracts. Then laser destruction of the sinus is performed with FiberLase VT laser, wavelength 1460 or 1520 nm, the laser energy 10-12 Watts. The fiber delivers energy homogeneously in a continuous way. Hemostasis by electrocautery. The wound is washed with povidone-iodine solution. Aseptic dressing is applied.

Timeline

• Start date: 2022-12-08
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Russia