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NOT YET RECRUITING
NCT07652099
NA

Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst

Sponsor: Elsan

View on ClinicalTrials.gov

Summary

This multicenter, prospective, randomized, open-label trial compares laser fiber treatment with conventional surgery in adults with non-abscessed pilonidal cyst. The main objective is to evaluate the incremental cost-utility ratio of laser fiber versus conventional surgery over 12 months from a societal perspective. Secondary objectives include 3-month cost-utility, healing time, closure at 3 months, recurrence at 12 months, postoperative complications, treatment parameters, postoperative pain, and duration of sick leave.

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06-15

Completion Date

2029-12-15

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

PROCEDURE

Laser fiber treatment

Use of a laser fiber introduced through the pilonidal cyst tract to destroy the cyst walls. Main steps include tract exploration, curettage, irrigation, two laser passes, and dry dressing.

PROCEDURE

Conventional surgery

Conventional surgical excision of the entire cystic area with packing and absorbent dressing.

Locations (2)

Clinique Esquirol Saint Hilaire ELSAN

Agen, France

Polyclinique du Parc - ELSAN

Caen, France