NCT07652099

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Dec 2029

First Submitted

Initial submission to the registry

June 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2029

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Non-abscessed Pilonidal Cyst

Keywords

Pilonidal diseasePilonidal sinusLaser fiberConventional surgeryCost-utility

Outcome Measures

Primary Outcomes (1)

  • Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery

    Calculated from total 12-month costs (direct medical, direct non-medical, indirect costs, including recurrences) and utility gain derived from EQ-5D-5L / QALY.

    12 months after intervention

Secondary Outcomes (8)

  • Incremental cost-utility ratio at 3 months

    3 months after intervention

  • Healing duration

    Up to 12 months after intervention

  • Closure of non-abscessed pilonidal cyst

    3 months after intervention

  • Recurrence of non-abscessed pilonidal cyst

    12 months after intervention

  • Postoperative complications

    Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12

  • +3 more secondary outcomes

Study Arms (2)

Laser fiber

EXPERIMENTAL

Laser fiber introduced through the cyst tract to destroy the cyst walls by thermal effect/burning; performed under general anesthesia with a small dry dressing afterwards.

Procedure: Laser fiber treatment

Conventional surgery

ACTIVE COMPARATOR

Complete excision of the cystic area by incision around the entire contour of the cyst, followed by placement of packing and an absorbent dressing; performed under general anesthesia.

Procedure: Conventional surgery

Interventions

Conventional surgeryPROCEDURE

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

Conventional surgery
Laser fiber treatmentPROCEDURE

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.

Laser fiber

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 years or older and younger than 80 years.
  • Patient for whom excision of a non-abscessed pilonidal cyst by laser fiber or conventional surgery is indicated.
  • Patient informed and having provided free, informed, written consent before any study-specific procedure.

You may not qualify if:

  • Acute abscess.
  • Contraindication to surgery and/or anesthesia.
  • Need for urgent intervention for non-abscessed pilonidal cyst.
  • No health insurance coverage/protection.
  • Legal protection measure or deprived of liberty by judicial or administrative decision.
  • Hospitalized without consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Esquirol Saint Hilaire ELSAN

Agen, 47000, France

Location

Polyclinique du Parc - ELSAN

Caen, 14000, France

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Central Study Contacts

Charlène Py, Eng

CONTACT

+33556003048charlene.py@elsan.care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

December 15, 2029

Study Completion (Estimated)

December 15, 2029

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)