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

NCT ID: NCT07194161

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Pilonidal Cyst Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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radical surgery

No interventions assigned to this group

laser treatment

No interventions assigned to this group

Eligibility Criteria

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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

* 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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique de la Sauvegarde

Lyon, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Benjamin Dr DARNIS

Role: primary

0033 4-37-49-66-77

Other Identifiers

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2024-06-049-DARNIS-SPIRIT

Identifier Type: -

Identifier Source: org_study_id

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