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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878655
Recruitment Status : Unknown
Verified July 2018 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : August 25, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease
SCCHN

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Visual Annalogue Scale for Global Quality of Life [ Time Frame: change over baseline and month 6 ]
    (rate between 0 and 10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878655


Contacts
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Contact: Roger VIVIEN, MD babin-e@chu-caen.fr
Contact: Emmanuel BABIN babin-e@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France, 14000
Contact: Emmanuel BABIN, MD, PhD         
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02878655    
Other Study ID Numbers: 14-059
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Keywords provided by University Hospital, Caen:
N0 clinical and radiological
dissection IIb sector