Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy

Last updated: September 18, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acne Inversa

Treatment

N/A

Clinical Study ID

NCT07194161
2024-06-049-DARNIS-SPIRIT
  • Ages > 14
  • All Genders

Study Summary

The goal of this observational study is to describe the impact of recurrence on the quality of life of patients treated with radical surgery and laser therapy.

The secondary objective is to describe in patients treated with radical surgery and laser treatment :

  • Intensity of pain and discomfort

  • Duration of nursing care since surgery

  • Duration of inactivity since intervention

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 14 or over

  • Patient has been informed of the objectives and conditions of the study and has notobjected to the collection of his/her data.

  • If the patient is under 18 years of age, both parents or the holder(s) of parentalauthority have been informed of their child's participation in the study and do notoppose it

  • Presenting a recurrence of pilonidal sinus after a first complete treatment byradical surgery or laser

Recurrence is defined by :

  • The presence of persistent troublesome symptoms more than 6 months after surgery:suppuration, iterative scar disunion, absence of healing despite care deemed optimalby the expert, recurrence of abscesses

  • The presence of a characteristic MRI image, if this examination has been carriedout: subcutaneous collection, in hyper T2.

Exclusion

Exclusion Criteria:

  • Symptoms less than 6 months old

  • First operation limited to simple abscess flattening

  • Atypical symptoms, without radiological confirmation of recurrence: isolated pain,induration without inflammatory phenomena

  • History of more than one elective surgery for pilonidal sinus

  • Pilonidal sinus associated with a posteriorly developed anal fistula

  • Persistence of a skin orifice, with no hair in it, without any symptoms

  • Patient under court protection, guardianship or curatorship

  • Mental deficiency or any other reason that may hinder comprehension of theinformation and non-opposition note0

Study Design

Total Participants: 100
Study Start date:
March 10, 2025
Estimated Completion Date:
March 31, 2026

Study Description

This is a single-centre exploratory study of patients previously treated for a pilonidal cyst who are consulting for a recurrence.

The study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).

The objective of this study does not impose any particular constraints. The only evaluation of the study is carried out when the patient comes in for consultation for a recurrence of a pilonidal cyst.

Quality of life will be assessed using the The MOS 36-item short-form health survey (SF-36) scale and the Wound quality of life in Chronic Wounds survey (Wound QoL17).

Pain and discomfort will be assessed using a simple numerical scale ranging from 0 to 10.

Connect with a study center

  • Clinique de la Sauvegarde

    Lyon 2996944, 69009
    France

    Active - Recruiting

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