Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE)

NCT04994730 | Unknown

• 1 other identifier: IC 2020-14
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone. The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.

Conditions

Cancer

Keywords

Exenteration; Surgery; Quality of life

Outcome Measures

Primary Outcomes (2)

• Functional Assessment of Cancer Therapy: General (FACT-G)

  The FACT-G questionnaire consists of 27 general items, with the patient scoring each item on a scale of 0 to 4. The final score is the sum of all the items.

  Baseline

• FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)

  The FACT-MBIS questionnaire consists of 21 items related to self-esteem and social comfort, each item is also scored on a scale of 0 to 4. The final score is the sum of all items.

  Baseline

Interventions

Quality of life according to the reconstruction technique BEHAVIORAL

For this retrospective analysis, 118 patients could be included, 17 of whom had undergone ante-brachial free flap reconstruction, 16 of whom had undergone this reconstruction within the last 2 years. The primary endpoint: Analysis of the quality of life score according to the reconstruction technique (free ante-brachial flap versus others) will be performed by a Wilcoxon-Mann-Whitney test.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,

You may qualify if:

• All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,

You may not qualify if:

• Persons under court protection.
• Persons not in a condition to give their consent.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nathalie BADOIS, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie BADOIS, MD

CONTACT

+33144324535; nathalie.badois@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 6, 2021
• Study Start: May 25, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)