Pilonidal CystSPIRITNCT07194161
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 of Pilonidal Cyst and Quality of Life, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pilonidal Cyst, Quality of Life
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting for a recurrence of pilonidal sinus previously treated as first-line treatment by radical surgery or laser.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, 69009
Benjamin Dr DARNIS, 0033 4-37-49-66-77, darnis@chirurgien-digestif.com
About this study
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.
- Conditions
- Pilonidal Cyst, Quality of Life
- Keywords
- pilonidal cyst, recurrence, quality of life, radical surgery, laser
- Medical subject headings
- Pilonidal Sinus, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| radical surgery | Not described | |
| laser treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (2)
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).
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start10 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal CystStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194161
- Sponsor's protocol ID
- 2024-06-049-DARNIS-SPIRIT
- Acronym
- SPIRIT
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
- ClinicalTrials.gov ID
- NCT07194161
- Acronym / sponsor ID
- SPIRIT / 2024-06-049-DARNIS-SPIRIT
- Conditions
- Pilonidal Cyst, Quality of Life
- Keywords
- pilonidal cyst, recurrence, quality of life, radical surgery, laser
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radical surgery | – | – |
| laser treatment | – | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting for a recurrence of pilonidal sinus previously treated as first-line treatment by radical surgery or laser.
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of recurrence of pilonidal cyst on patient's quality of life
Time frame: Day 0
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.
2 secondary outcomes
The intensity of pain and discomfort
Time frame: Day 0
Quality of life assessment with Wound QoL17 questionnaire
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Cyst and Quality of Life, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of recurrence of pilonidal cyst on patient's quality of life (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.