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RecruitingNCT07194161SPIRITUpdated Sep 26, 2025

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

An observational study in Pilonidal Cyst and Quality of Life, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
14 Years and older
Sex
All
01

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
Read the detailed 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.

02

Conditions studied

  • Pilonidal Cyst
  • Quality of Life

Keywords

  • pilonidal cyst
  • recurrence
  • quality of life
  • radical surgery
  • laser
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's planned enrollment of 100 is below the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

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 the information and non-opposition note0
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • radical surgery
  • laser treatment
06

What researchers measure

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.

    Time frame: Day 0

Secondary outcomes

  1. The intensity of pain and discomfort

    The intensity of pain and discomfort will be assessed using a simple numerical scale ranging from 0 (no pain/discomfort) to 10 (worst pain/discomfort ever experienced).

    Time frame: Day 0

  2. Quality of life assessment with Wound QoL17 questionnaire

    The Wound QoL17 is a questionnaire on quality of life in relation to chronic wounds. It comprises 17 items relating to the patient's experience over the last 7 days, which can be classified into three categories relating to daily life, the body and the psyche.

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07194161
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Mar 10, 2025
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Sep 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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