SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitario La Paz

About this trial

Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the sacrococcygeal region that frequently affects young adults, often causing pain, drainage, and recurrent infection. Traditional surgical approaches such as wide excision or flap techniques may result in prolonged healing times, relevant postoperative pain, and recurrence rates up to 20-30%.

The SiLaC (Sinus Laser-Assisted Closure) technique is a minimally invasive procedure that uses a 1470-nm diode laser fiber to ablate the sinus epithelium and induce concentric contraction of the tract. International studies have reported promising results with faster recovery, minimal wound care, and low morbidity.

This prospective single-center cohort study aims to evaluate the clinical outcomes and perceived recovery time of adult patients treated with the SiLaC® technique at Hospital Universitario La Paz (Madrid, Spain). The main outcome is the total recovery time perceived by patients after surgery. Secondary outcomes include postoperative complications, recurrence rate, pain intensity, need for wound care, and patient satisfaction. Data will be collected from medical records and structured follow-up interviews.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Clinical diagnosis of chronic pilonidal sinus disease.

Undergoing surgery using the SiLaC (Sinus Laser-Assisted Closure) technique.

Signed informed consent for the use of anonymized clinical data for research purposes.

Disqualifiers

Patients with inflammatory bowel disease or complex anorectal fistulas.

Severe immunosuppression (active chemotherapy, high-intensity immunosuppressive therapy, uncontrolled HIV).

Prior pelvic radiotherapy.

Missing essential clinical data required for outcome assessment

Trial population

Adult patients (≥18 years) with chronic pilonidal sinus disease who undergo laser-assisted closure (SiLaC®) at the Department of General and Digestive Surgery, Coloproctology Section, Hospital Universitario La Paz (Madrid, Spain). Participants will be included consecutively between August 2024 and January 2026, with a minimum follow-up of 6 months after surgery.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • SilaC

    Procedure/Surgery

    The SiLaC procedure is a minimally invasive laser technique for the management of chronic pilonidal sinus. It uses a 1470-nm diode laser radial fiber to ablate the sinus tract epithelium after curettage, inducing concentric contraction of the cavity. In this study, patients are observed as part of routine clinical care; the procedure is not assigned or modified by the study protocol.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: SilaC1 intervention

Trial outcomes

Primary outcomes

1

Total perceived recovery time

Number of days from surgery to full return to normal activities, as reported by the patient during follow-up interviews

Time frame
90 days

Secondary outcomes

1

Postoperative complications

Any adverse event (infection, seroma, hematoma, abscess, persistent pain ≥ EVA 4, reintervention).

Time frame
30 days
2

Pain intensity

Pain intensity measured using the Visual Analog Scale for pain (VAS), a 0-10 scale where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Higher scores reflect worse pain. Pain will be assessed at 24-48 hours and on postoperative day 7

Time frame
7 days
3

recurrence

Reappearance of drainage, fistulous orifices, or need for a new procedure after initial healing

Time frame
90 days
4

Need for local wound care

Number of dressing visits at hospital or primary care center

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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