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Active Not Recruiting
NCT05715983
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.
Conditions: Pilonidal Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 164
Sponsor: Russian Society of Colorectal Surgeons
Location: Russian Federation
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.
Eligibility Criteria
Inclusion Criteria:Written informed consentChronic 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)____ Non-inclusion criteria1. 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 criteria1.
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-
Source: ClinicalTrials.gov (NCT05715983). StuddyBuddy aggregates publicly available trial information.