Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06865794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Plastic and Aesthetic Surgery on Self-esteem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-esteem score assessed by the Rosenberg self-esteem scale', 'timeFrame': 'Pre-operatively, at 3 and 12 months post-op', 'description': 'Self-esteem score assessed by the Rosenberg self-esteem scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plastic surgery', 'cosmetic surgery', 'aesthetic surgery'], 'conditions': ['Self Esteem']}, 'descriptionModule': {'briefSummary': "The primary objective of QUALIPLAST is to evaluate the impact of plastic and aesthetic surgery interventions on patients' self-esteem. While the demand for these procedures is steadily increasing worldwide, patients' motivations often extend beyond purely aesthetic concerns, encompassing significant psychological and emotional expectations. However, despite the growing popularity of these interventions, scientific literature remains limited when it comes to the systematic and long-term evaluation of their effects on patients' self-esteem and overall well-being.\n\nThe majority of existing studies focus on short-term outcomes or functional and physical aspects, often overlooking the psychological and emotional dimensions that play a crucial role in post-operative satisfaction. Furthermore, much research is limited to specific procedures, without adopting a comprehensive approach to plastic and aesthetic surgery. This lack of robust and generalisable data hinders a full understanding of how these interventions influence self-esteem across different types of surgeries and patient profiles.\n\nQUALIPLAST stands out due to its multicentric, prospective, and large-scale nature, involving a wide range of procedures and collecting longitudinal data before the intervention, as well as at 3 and 12 months post-operatively. It will allow for the observation of self-esteem changes over time, providing a more complete and nuanced understanding of the effects of surgery.\n\nThis project relies on standardized and validated measurement tools, such as the Rosenberg Self-Esteem Scale, to ensure the reliability and comparability of the results. By addressing the current gaps in the literature, QUALIPLAST aims not only to enrich scientific knowledge in this field but also to provide valuable insights for healthcare professionals to improve patient care and tailor clinical practices based on the identified psychological needs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting a plastic surgeon for one of the following operations :\n\n* Breast augmentation\n* Breast reduction\n* Breast lift\n* Facelift\n* Otoplasty\n* Rhinoplasty\n* Blepharoplasty\n* Abdominoplasty\n* Brachioplasty\n* Cruroplasty\n* Liposuction\n* Gender affirmation: breast augmentation\n* Gender affirmation: Facial feminisation\n* Gender affirmation: Thoracoplasty\n* Botox / Hyaluronic acid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients consulting a plastic surgeon for one of the following operations:\n\n* Breast augmentation\n* Breast reduction\n* Breast lift\n* Facelift\n* Otoplasty\n* Rhinoplasty\n* Blepharoplasty\n* Abdominoplasty\n* Brachioplasty\n* Cruroplasty\n* Liposuction\n* Gender affirmation: breast augmentation\n* Gender affirmation: Facial feminisation\n* Gender affirmation: Thoracoplasty\n* Botox / Hyaluronic acid\n\nPatients who agreed to take part in the study\n\nExclusion Criteria:\n\n* Pregnant, parturient or breastfeeding women\n* Minors\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons receiving psychiatric care\n* Persons admitted to a healthcare or social institution for purposes other than research\n* Adults under a legal protection measure (guardianship, curators)'}, 'identificationModule': {'nctId': 'NCT06865794', 'acronym': 'QUALIPLAST', 'briefTitle': 'Impact of Plastic and Aesthetic Surgery on Self-esteem', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Plastic and Aesthetic Surgery on Self-esteem, a Prospective Multicentre Study', 'orgStudyIdInfo': {'id': '69HCL25_0154'}, 'secondaryIdInfos': [{'id': '2025-A00418-41', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast augmentation', 'description': 'Adult female patient undergoing breast augmentation for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Breast reduction', 'description': 'Adult female patient undergoing breast reduction for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Mastopexy', 'description': 'Adult female patient undergoing Mastopexy (Breast lift) for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Facelift', 'description': 'Adult patient undergoing facelift for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Otoplasty', 'description': 'Adult patient undergoing otoplasty for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Rhinoplasty', 'description': 'Adult patient undergoing rhinoplasty for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Blepharoplasty', 'description': 'Adult patient undergoing blepharoplasty for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Abdominoplasty', 'description': 'Adult patient undergoing abdominoplasty for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Brachioplasty', 'description': 'Adult patient undergoing brachioplasty for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Thigh lift', 'description': 'Adult patient undergoing thigh lift for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Liposuction', 'description': 'Adult patient undergoing liposuction for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Gender affirmation: breast augmentation', 'description': 'Adult patient undergoing breast augmentation gender affirmation surgery.', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Gender affirmation: facial feminisation', 'description': 'Adult patient undergoing facial feminisation gender affirmation surgery', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Gender affirmation : thoracoplasty', 'description': 'Adult patient undergoing thoracoplasty gender affirmation surgery', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'label': 'Injectables/Fillers', 'description': 'Adult patient undergoing Botox or Hyaluronic acid injections for aesthetic reason', 'interventionNames': ['Other: Questionnaire and Physical Exam']}], 'interventions': [{'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['Rosenberg self-esteem scale'], 'description': 'Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op', 'armGroupLabels': ['Abdominoplasty', 'Blepharoplasty', 'Brachioplasty', 'Breast augmentation', 'Breast reduction', 'Facelift', 'Gender affirmation : thoracoplasty', 'Gender affirmation: breast augmentation', 'Gender affirmation: facial feminisation', 'Injectables/Fillers', 'Liposuction', 'Mastopexy', 'Otoplasty', 'Rhinoplasty', 'Thigh lift']}, {'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['FACE-Q psychological sub-scale'], 'description': 'FACE-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op', 'armGroupLabels': ['Blepharoplasty', 'Facelift', 'Injectables/Fillers', 'Otoplasty', 'Rhinoplasty']}, {'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['BREAST-Q psychological sub-scale'], 'description': 'BREAST-Q psychological sub-scale pre-operatively, at 3 and 12 months post-op', 'armGroupLabels': ['Breast augmentation', 'Breast reduction', 'Mastopexy']}, {'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['BSIQ-SF (short-form version of the Body Self-Image Questionnaire)'], 'description': 'BSIQ-SF pre-operatively, at 3 and 12 months post-op', 'armGroupLabels': ['Abdominoplasty', 'Brachioplasty', 'Liposuction', 'Thigh lift']}, {'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['FLZ (Fragen zur Lebenszufriedenheit / Questions on Life Satisfaction) psychological sub-scale'], 'description': 'FLZ psychological sub-scale pre-operatively, at 3 and 12 months post-op', 'armGroupLabels': ['Gender affirmation : thoracoplasty', 'Gender affirmation: breast augmentation', 'Gender affirmation: facial feminisation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69002', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Emmanuel DELAY', 'role': 'CONTACT', 'email': 'Emmanuel.delay@lyon.unicancer.fr', 'phone': '+33 4 72 56 07 06'}], 'facility': 'Consultation Office of Dr. Emmanuel DELAY', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Ali Mojallal, Md, Phd', 'role': 'CONTACT', 'email': 'Alain-Ali.mojallal@chu-lyon.fr', 'phone': '+33 4 26 73 28 22'}], 'facility': 'Hospices Civils of Lyon - Croix-Rousse hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Hugo DESPERT', 'role': 'CONTACT', 'email': 'Hugo.despert@gmail.com', 'phone': '+33 6 41 50 23 29'}], 'overallOfficials': [{'name': 'Hugo Despert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils of Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}