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

NCT ID: NCT02878655

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

SCCHN

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caen University Hospital

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Roger VIVIEN, MD

Role: CONTACT

babin-e@chu-caen.fr

Emmanuel BABIN

Role: CONTACT

babin-e@chu-caen.fr

Facility Contacts

Emmanuel BABIN, MD, PhD

Role: primary

Other Identifiers

14-059

Identifier Type: -

Identifier Source: org_study_id