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Decisional Regret in Open Partial Horizontal Laryngectomy

Decisional Regret in Open Partial Horizontal Laryngectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06805071
Enrollment
100
Registered
2025-02-03
Start date
2024-05-01
Completion date
2025-05-31
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Squamous Cell Carcinoma

Brief summary

Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY

Exclusion criteria

* Previous surgical treatment of the larynx * Previous CT-RT of the head and neck district

Design outcomes

Primary

MeasureTime frameDescription
Decisional Regret ScaleFrom the surgery to the enrollment time (6 months post-treatment)Evaluation of subjective regret about the therapeutic choice

Secondary

MeasureTime frameDescription
DASS-21 QuestionnaireFrom the surgery to the enrollment time (6 months post-treatment)21 items-questionnaire about depression, anxiety and stress during the post-treatment period
Chicago Priority ScaleFrom the surgery to the enrollment time (6 months post-treatment)12 items-ranking of Oncological therapeutic objectives of the Head and Neck patient
VHI-10From 6 Months after surgery until the end of the studySelf evaluation of the dysphonia after surgery
MD Anderson Dysphagia InventoryFrom 6 Months after surgery until the end of the studySelf evaluation of dysphagia post surgical treatment + adjuvant therapy if administered

Countries

Italy

Contacts

Primary ContactMatteo Fermi, MD
matteo.fermi3@unibo.it0512144172
Backup ContactAlessandro Rosti, MD
alessandro.rosti3@studio.unibo.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026