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

Not Applicable

Active, not recruiting

• Conditions: Pilonidal Disease
• Interventions: Procedure: Bascom II procedure; Procedure: SiLaC

• Registration Number: NCT05715983
• Lead Sponsor: Russian Society of Colorectal Surgeons

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.

Study Timeline

• Study Start: 2022-12-08
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 164

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

12. 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.

13. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bascom II procedure	Bascom II procedure	Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.
Sinus Laser Closer (SiLaC)	SiLaC	Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction

Primary Outcome Measures

Name	Time	Method
Reccurance rate	starting from 6 months after surgery and up to 3 years after surgery]	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)

Secondary Outcome Measures

Name	Time	Method
Inhospital stay	30 days]	The duration of treatment after surgery until discharge from the hospital (in days)
Wound hemorrhage rate	Within 30 days from surgery]	The rate of hemorrhage from wound edges
Operative time	1 day	The length of surgery in minutes
Overall quality of life	1- 7 days after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery	Assessed with patient-reported questionnaire SF-12. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
Wound healing speed	3 years after surgery	The time period between surgery and complete healing of the wound
Wound seroma rate	90 days after surgery	The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
Patient satisfaction with cosmetic results	6 months, 1 year, 3 years	Patient-reported with a scale 0-10, where 0 corresponds to \"completely unsatisfactory\" and 10 corresponds to \"completely satisfactory\". A total score is registered.
Secondary surgery rate	3 years after surgery	The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Postoperative pain intensity - late postoperative period	On 10th, 14th, 21st, 30 day after surgery]	Pain intensity will be evaluated once a day with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded.
Surgical site infection rate	Frame: 3 month after surgery	The rate of infectious inflammation of the wound as confirmed by the observing doctor
Bloodloss	1 day	The amount of blood lost during surgery
Postoperative pain intensity	On 1st, 3rd, 5th and 7th postoperative day]	early postoperative period Pain intensity will be evaluated twice a day (in the morning and in the evening) with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded.

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation