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

NCT07194161 | Recruiting

• 1 other identifier: 2024-06-049-DARNIS-SPIRIT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pilonidal Cyst; Quality of Life

Keywords

pilonidal cyst; recurrence; quality of life; radical surgery; laser

Outcome Measures

Primary Outcomes (1)

• Impact of recurrence of pilonidal cyst on patient's quality of life

  Quality of life will be assessed using the SF36 scale. The SF-36 health status questionnaire has been validated in several languages, including English. It is a generic score for assessing quality of life. An average physical score (PCS = Physical Composite Score) and an average mental score (MCS = Mental Composite Score) can be calculated using an established algorithm. The SF-36 can be used by comparing (searching for correlations) the scores of the different domains of the SF-36 in a study population with those of the normal population, or by searching for correlations between the scores of the different domains of the SF-36 and other explanatory medical, functional, social, etc. variables.

  Day 0

Secondary Outcomes (2)

• The intensity of pain and discomfort

  Day 0

• Quality of life assessment with Wound QoL17 questionnaire

  Day 0

Study Arms (2)

radical surgery

laser treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting for a recurrence of pilonidal sinus previously treated as first-line treatment by radical surgery or laser.

You may qualify if:

• Patient aged 14 or over
• Patient has been informed of the objectives and conditions of the study and has not objected to the collection of his/her data.
• If the patient is under 18 years of age, both parents or the holder(s) of parental authority have been informed of their child's participation in the study and do not oppose it
• Presenting a recurrence of pilonidal sinus after a first complete treatment by radical 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 optimal by the expert, recurrence of abscesses
• The presence of a characteristic MRI image, if this examination has been carried out: subcutaneous collection, in hyper T2.

You may not qualify if:

• 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 the information and non-opposition note0

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus; Recurrence

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: March 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)