Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale.
- Who it may be relevant to
- Registry conditions: Cryo Analgesia, Pectus Surgery. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis: Neuropathic Pain, Quality of Life and Sensory Recovery in a Paediatric Cohort Following Pectus Excavatum Repair
Overview
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management
Detailed description
Follow up of patients after receiving percutaneous cryoneurolysis for pectus excavatum repair, who undergo a physical examination and a neurosensory assessment of the chest wall at 1, 3, 6, 12, and 24 months postoperatively, corresponding to the scheduled follow-up visits. In addition, to evaluate neuropathic pain, chronic pain, and quality of life, patients complete validated questionnaires.
Interventions
- Diagnostic test Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale
Assessment tools include validated questionnaires - the S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs, range 0-24, higher scores indicating greater likelihood of neuropathic pain) and the PedsQL™ (Pediatric Quality of Life Inventory, v4.0, Adolescent/Young Adult Report, range 0-100, higher scores indicating better health-related quality of life) - together with the Patient Self-Assessment Sensory Scale (range 0-10, 0 indicating no sensitivity and 10 indicating normal se
Primary outcome measures
- Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results [Time frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.]
Secondary outcome measures (3)
- Pediatric Quality of Life Inventory (PedsQL) questionnaire [Time frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.]
- chronic postoperative pain (CPSP) assessment [Time frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.]
- sensitivity recovery using the Patient Self-Assessment Sensory Scale [Time frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.]
Eligibility criteria
Inclusion criteria
- Patients who underwent percutaneous cryoneurolysis.
- Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
- Signed informed consent.
Exclusion criteria
- Refusal to participate in the study
- Peripheral nervous system disorders
- Age < 14 years
- Failure to attend scheduled follow-up visits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- ASST Papa Giovanni XXIII — Bergamo
Identifiers
NCT: NCT07657845 · CRYOFUP