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

NCT05715983 | Unknown DMC

• 1 other identifier: 25-22
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pilonidal Disease

Keywords

Bascom II, SiLaC, Sinus Laser Closer

Outcome Measures

Primary Outcomes (1)

• Reccurance rate

  clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound)

  starting from 6 months after surgery and up to 3 years after surgery]

Secondary Outcomes (12)

• Operative time

  1 day

• Bloodloss

  1 day

• Postoperative pain intensity

  On 1st, 3rd, 5th and 7th postoperative day]

• Postoperative pain intensity - late postoperative period

  On 10th, 14th, 21st, 30 day after surgery]

• Surgical site infection rate

  Frame: 3 month after surgery

Study Arms (2)

Bascom II procedure

ACTIVE COMPARATOR

Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.

Procedure: Bascom II procedure

Sinus Laser Closer (SiLaC)

ACTIVE COMPARATOR

Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction

Procedure: SiLaC

Interventions

Bascom II procedure 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.

Bascom II procedure

SiLaC 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 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.

Sinus Laser Closer (SiLaC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Chronic primary or recurrent pilonidal sinus at the remission stage.
• Presence or absence of secondary orifices.
• Planned surgical treatment with excision of pilonidal sinus.
• Location of the orifices should not be less than 1 cm.
• Location of secondary orifices less 2 cm from the natal cleft.
• Distance between bilateral symmetrical positions of secondary orifices should not be more than 2 cm.
• 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.
• Sinus diameter (width) in the greatest dimension should not exceed 3 cm, according to the ultrasound of the soft tissues of the sacrococcygeal region.
• Sinus must be located directly under the skin, according to the ultrasound findings.
• Lack of fixation of the cavity to the coccyx, when evaluating data on pelvic contrast-enhanced magnetic resonance imaging (MRI)
• \. 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.
• \. ASA \> III. 6. Predictable impossibility of following the protocol 7. Pregnancy

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Sechenov University

Moscow, 119435, Russia

Location

Study Officials

• Inna Tulina, PhD

  I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435

  PRINCIPAL INVESTIGATOR

• Petr Tsarkov, Prof.

  I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Russian Society of Colorectal Surgeons

Model Details: assignment prospective, multi-centre.parallel-arm randomized controlled trial

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: December 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)