Bilateral Elective Neck Dissection in Salvage Total Laryngectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-03-01

Brief Summary

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The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.

Detailed Description

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Conditions

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Neck Cancer Larynx Larynx Cancer Neck

Keywords

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neck dissection SALVAGE TOTAL LARYNGECTOMY

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Elective bilateral neck dissection in cN0 patients

Radical modified type 3 selective bilaterale elective neck dissection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

-patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).

Exclusion Criteria

* patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Galli Jacopo

Professor, head of dept. of Otorinolaringology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stefano Settimi

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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3364

Identifier Type: -

Identifier Source: org_study_id