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

NCT07260643 | Not Yet Recruiting

• 1 other identifier: Hospital Universitario La Paz
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pilonidal Sinus Disorder; Pilonidal Sinus; Pilonidal Cysts; Pilonidal Sinus Treatment; Pilonidal Cyst Without Abscess

Keywords

Pilondal sinus; Pilonidal Cyst; SilaC; laser-assisted closure; minimal invasive surgery; coloproctology; postoperative recovery

Outcome Measures

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

  90 days

Secondary Outcomes (4)

• Postoperative complications

  30 days

• Pain intensity

  7 days

• recurrence

  90 days

• Need for local wound care

  30 days

Study Arms (1)

SilaC

Single cohort including all consecutive adult patients operated on using the SiLaC technique between August 2024 and January 2026. Data collected retrospectively and prospectively from clinical records and follow-up interviews

Procedure: SilaC

Interventions

SilaC PROCEDURE

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.

SilaC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Luis Asensio-Gomez, Consultant

CONTACT

0034 91727000; lasensio@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share