Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-20 @ 7:02 AM
Study NCT ID:
NCT07194161
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Impact of recurrence of pilonidal cyst on patient's quality of life", 'timeFrame': 'Day 0', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The intensity of pain and discomfort', 'timeFrame': 'Day 0', 'description': '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).'}, {'measure': 'Quality of life assessment with Wound QoL17 questionnaire', 'timeFrame': 'Day 0', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pilonidal cyst', 'recurrence', 'quality of life', 'radical surgery', 'laser'], 'conditions': ['Pilonidal Cyst', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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.\n\nThe secondary objective is to describe in patients treated with radical surgery and laser treatment :\n\n* Intensity of pain and discomfort\n* Duration of nursing care since surgery\n* Duration of inactivity since intervention', 'detailedDescription': 'This is a single-centre exploratory study of patients previously treated for a pilonidal cyst who are consulting for a recurrence.\n\nThe study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).\n\nThe 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.\n\nQuality 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).\n\nPain and discomfort will be assessed using a simple numerical scale ranging from 0 to 10.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting for a recurrence of pilonidal sinus previously treated as first-line treatment by radical surgery or laser.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 14 or over\n* Patient has been informed of the objectives and conditions of the study and has not objected to the collection of his/her data.\n* 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\n* Presenting a recurrence of pilonidal sinus after a first complete treatment by radical surgery or laser\n\nRecurrence is defined by :\n\n* 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\n* The presence of a characteristic MRI image, if this examination has been carried out: subcutaneous collection, in hyper T2.\n\nExclusion Criteria:\n\n* Symptoms less than 6 months old\n* First operation limited to simple abscess flattening\n* Atypical symptoms, without radiological confirmation of recurrence: isolated pain, induration without inflammatory phenomena\n* History of more than one elective surgery for pilonidal sinus\n* Pilonidal sinus associated with a posteriorly developed anal fistula\n* Persistence of a skin orifice, with no hair in it, without any symptoms\n* Patient under court protection, guardianship or curatorship\n* Mental deficiency or any other reason that may hinder comprehension of the information and non-opposition note0"}, 'identificationModule': {'nctId': 'NCT07194161', 'acronym': 'SPIRIT', 'briefTitle': 'Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy', 'orgStudyIdInfo': {'id': '2024-06-049-DARNIS-SPIRIT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'radical surgery'}, {'label': 'laser treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69009', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Dr DARNIS', 'role': 'CONTACT', 'email': 'darnis@chirurgien-digestif.com', 'phone': '0033 4-37-49-66-77'}], 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}