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

NCT ID: NCT05715983

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2025-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bascom II procedure

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

Group Type: ACTIVE_COMPARATOR

Bascom II procedure

Intervention Type: 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.

Sinus Laser Closer (SiLaC)

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

Group Type: ACTIVE_COMPARATOR

SiLaC

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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)

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

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Society of Colorectal Surgeons

OTHER

Sponsor Role: lead

Responsible Party

Darya Shlyk

Russian Society of Colorectal Surgeons

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inna Tulina, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Petr Tsarkov, Prof.

Role: STUDY_DIRECTOR

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

Locations

Sechenov University

Moscow, , Russia

Countries

Russia

Other Identifiers

25-22

Identifier Type: -

Identifier Source: org_study_id