Decisional Regret in Open Partial Horizontal Laryngectomy

Recruiting

• Conditions: Laryngeal Squamous Cell Carcinoma

• Registration Number: NCT06805071
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Primary Completion: 2025-01-25
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decisional Regret Scale	From the surgery to the enrollment time (6 months post-treatment)	Evaluation of subjective regret about the therapeutic choice

Secondary Outcome Measures

Name	Time	Method
DASS-21 Questionnaire	From 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 Scale	From the surgery to the enrollment time (6 months post-treatment)	12 items-ranking of Oncological therapeutic objectives of the Head and Neck patient
VHI-10	From 6 Months after surgery until the end of the study	Self evaluation of the dysphonia after surgery
MD Anderson Dysphagia Inventory	From 6 Months after surgery until the end of the study	Self evaluation of dysphagia post surgical treatment + adjuvant therapy if administered

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, BO, Italy