Clinical trial NCT05715983: Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.
Official title: Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Disease
Keywords: Bascom II, SiLaC, Sinus Laser Closer
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assignment prospective, multi-centre.parallel-arm randomized controlled trial
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Reccurance rate
timeFrame: starting from 6 months after surgery and up to 3 years after surgery]
Secondary outcomes:
measure: Operative time
timeFrame: 1 day
measure: Bloodloss
timeFrame: 1 day
measure: Postoperative pain intensity
timeFrame: On 1st, 3rd, 5th and 7th postoperative day]
measure: Postoperative pain intensity - late postoperative period
timeFrame: On 10th, 14th, 21st, 30 day after surgery]
measure: Surgical site infection rate
timeFrame: Frame: 3 month after surgery
measure: Overall quality of life
timeFrame: 1- 7 days after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
measure: Secondary surgery rate
timeFrame: 3 years after surgery
measure: Wound healing speed
timeFrame: 3 years after surgery
measure: Wound hemorrhage rate
timeFrame: Within 30 days from surgery]
measure: Wound seroma rate
timeFrame: 90 days after surgery
measure: Patient satisfaction with cosmetic results
timeFrame: 6 months, 1 year, 3 years
measure: Inhospital stay
timeFrame: 30 days]
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435
name: Inna Tulina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435
name: Petr Tsarkov, Prof.
role: STUDY_DIRECTOR
References: