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Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis (CRYOFUP)

17 juni 2026 bijgewerkt door: Stefano Mariconti, Papa Giovanni XXIII Hospital

Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis: Neuropathic Pain, Quality of Life and Sensory Recovery in a Paediatric Cohort Following Pectus Excavatum Repair

Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

50

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Italië
    • BG
      • Bergamo, BG, Italië, 24127
        • Werving
        • Asst Papa Giovanni Xxiii
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management

All patients who underwent surgical correction of pectus excavatum via the Nuss procedure between July 1, 2022 and February 28, 2026 are considered eligible for enrollment. Additionally, for the prospective component, patients scheduled for surgery up to December 31, 2026 at the Pediatric Surgery department of our institution will be considered eligible.

Inclusion criteria:

Age greater than 14 years. Patients who underwent percutaneous cryoneurolysis. Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.

Exclusion criteria:

Patients who withhold consent to participate in the study, patients with pre-existing neurological conditions, and patients who do not attend the scheduled follow-up visits will be excluded from the study.
Diagnostische toets: 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 sensitivity) and a structured physical examination of thoracic sensitivity. These tools are administered at pre-specified follow-up timepoints. The physical examination assesses four sensory modalities corresponding to specific afferent fibre classes of the intercostal nerves: cold thermal sensation (Aδ fibres, ice-water contact, 4-10°C), warm thermal sensation (C fibres, ~40°C water), light touch (Aβ fibres, camel-hair brush), and pressure sensitivity (Aβ fibres, Von Frey filament 5.07/10g)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
Tijdsspanne: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
To assess the incidence of neuropathic pain using the validated S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs) scale, administered at the scheduled follow-up visits. The S-LANSS score ranges from 0 to 24, with higher scores indicating greater likelihood and severity of neuropathic pain (a score ≥12 is suggestive of pain of predominantly neuropathic origin
The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pediatric Quality of Life Inventory (PedsQL) questionnaire
Tijdsspanne: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
To describe the quality of life of patients using a specific validated questionnaire appropriate for adolescents and young adults (Pediatric Quality of Life Inventory - PedsQL™ version 4.0 for adolescents and young adults). The PedsQL total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
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
Tijdsspanne: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
To describe the incidence of chronic postoperative pain (CPSP), defined as persistence of pain beyond one month, according to two parameters: direct measurement using the NRS (Numeric Rating Scale) for pain intensity, and indirect measurement through consumption of analgesic medications included in the institutional current protocol (acetaminophen and NSAIDs). The NRS ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
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
Tijdsspanne: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
To describe the evolution of thoracic thermotactile hypoesthesia over time, starting from the day of cryoneurolysis, using the Patient Self-Assessment Sensory Scale. The scale ranges from 0 to 10, with 0 indicating no sensitivity (complete anaesthesia) and 10 indicating maximal/normal sensitivity, with higher scores indicating better (more complete) sensory recovery.
The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Papa Giovanni XXIII Hospital

Onderzoekers

  • Studie stoel: Ezio Bonanomi, MD, Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 februari 2025

Primaire voltooiing (Werkelijk)

13 juni 2026

Studie voltooiing (Geschat)

15 januari 2029

Studieregistratiedata

Eerst ingediend

13 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CRYOFUP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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