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Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis (CRYOFUP)

17. juni 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • BG
      • Bergamo, BG, Italien, 24127
        • Rekruttering
        • Asst Papa Giovanni XXIII
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pediatric Quality of Life Inventory (PedsQL) questionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Papa Giovanni XXIII Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2025

Primær færdiggørelse (Faktiske)

13. juni 2026

Studieafslutning (Anslået)

15. januar 2029

Datoer for studieregistrering

Først indsendt

13. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRYOFUP

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