Decisional Regret in Open Partial Horizontal Laryngectomy

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
        • Contact:
          • Matteo Fermi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with laryngeal squamous cell carcinoma of any stage amenable of organ preservation surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Regret Scale
Time Frame: From the surgery to the enrollment time (6 months post-treatment)
Evaluation of subjective regret about the therapeutic choice
From the surgery to the enrollment time (6 months post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASS-21 Questionnaire
Time Frame: From the surgery to the enrollment time (6 months post-treatment)
21 items-questionnaire about depression, anxiety and stress during the post-treatment period
From the surgery to the enrollment time (6 months post-treatment)
Chicago Priority Scale
Time Frame: From the surgery to the enrollment time (6 months post-treatment)
12 items-ranking of Oncological therapeutic objectives of the Head and Neck patient
From the surgery to the enrollment time (6 months post-treatment)
VHI-10
Time Frame: From 6 Months after surgery until the end of the study
Self evaluation of the dysphonia after surgery
From 6 Months after surgery until the end of the study
MD Anderson Dysphagia Inventory
Time Frame: From 6 Months after surgery until the end of the study
Self evaluation of dysphagia post surgical treatment + adjuvant therapy if administered
From 6 Months after surgery until the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Matteo Fermi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

January 25, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DROPHL-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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