Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS (QDV2b)

The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.

Study Overview

• Status: Unknown
• Conditions: SCCHN

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Caen University Hospital
    • Contact: Emmanuel BABIN, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector

Description

Inclusion Criteria:

• Patient with SCCHN histologically proven N0 clinical and radiological
• Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
• Patient candidate for a neck dissection fonctonnel
• Life expectancy> 3 months
• Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
• Age over 18 ans
• Patient was informed of the study
• Patient fluent French

Exclusion Criteria:

• Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
• Patient has at the time of examination of recurrence of signs or other scalable neoplasia
• Uncontrolled Infectious diseases
• Neoadjuvant radiotherapy
• Patient nursing or pregnant or lack of contraception during their reproductive
• Intercurrent pathology involving life-threatening
• Any medical or psychological condition associated that could compromise the patient's ability to participate in the study
• Inability to submit to medical follow-up study for geographical, social or psychic

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Annalogue Scale for Global Quality of Life	(rate between 0 and 10)	change over baseline and month 6

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: N0 clinical and radiological; dissection IIb sector
• Other Study ID Numbers: 14-059 (Other Identifier: US Oncology Research/McKesson Specialty Health, Inc.)