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

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

NCT ID: NCT05715983

Condition: Pilonidal Disease

Conditions: Official terms:
Pilonidal Sinus
Paranasal Sinus Diseases

Conditions: Keywords:
Bascom II, SiLaC, Sinus Laser Closer

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: assignment prospective, multi-centre.parallel-arm randomized controlled trial

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking description: double

Intervention:

Intervention type: Procedure
Intervention name: Bascom II procedure
Description: 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.
Arm group label: Bascom II procedure

Intervention type: Procedure
Intervention name: SiLaC
Description: 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.
Arm group label: Sinus Laser Closer (SiLaC)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Written informed consent 2. Chronic primary or recurrent pilonidal sinus at the remission stage. 3. Presence or absence of secondary orifices. 4. Planned surgical treatment with excision of pilonidal sinus. 5. Location of the orifices should not be less than 1 cm. 6. Location of secondary orifices less 2 cm from the natal cleft. 7. Distance between bilateral symmetrical positions of secondary orifices should not be more than 2 cm. 8. Length of the sinus in the greatest dimension, according to the ultrasound of the soft tissue of the sacrococcygeal region, should not exceed 7 cm. 9. Sinus diameter (width) in the greatest dimension should not exceed 3 cm, according to the ultrasound of the soft tissues of the sacrococcygeal region. 10. Sinus must be located directly under the skin, according to the ultrasound findings. 11. Lack of fixation of the cavity to the coccyx, when evaluating data on pelvic contrast-enhanced magnetic resonance imaging (MRI) ____ Non-inclusion criteria 1. Acute pilonidal sinus abscess 2. The secondary openings (orifice) position more than 3 cm from the midline. 3. Length of the cavity in the greatest dimension, according to the results of ultrasound examination, exceeds 6 cm 4. Width (diameter) of the sinus in the greatest dimension, according to the results of the ultrasound, more than 3 cm. 5. ASA > III. 6. Predictable impossibility of following the protocol 7. Pregnancy _____ Exclusion criteria 1. The patients lost for the follow-up 2. The patient's refusal to continue participate in the investigation. 3. Impossibility of the operation performing in the planned scope -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sechenov University

Address:
City: Moscow
Zip: 119435
Country: Russian Federation

Start date: December 8, 2022

Completion date: January 31, 2025

Lead sponsor:
Agency: Russian Society of Colorectal Surgeons
Agency class: Other

Source: Russian Society of Colorectal Surgeons

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05715983