Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction

NCT06865313 | Completed

• 1 other identifier: 2023-05-022-CS
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor

Conditions

Maxillary Sinus Squamous Cell Carcinoma

Keywords

Maxillectomy; Reconstruction; Scapula; Tracheotomy; Functional; Aesthetic

Outcome Measures

Primary Outcomes (4)

• time to resumption of oral feeding

  time to resumption of oral feeding after the surgery, measuring in days

  through study completion, an average of 15 days

• duration of hospitalization in a continuing care unit

  hospitalization in a continuing care unit after the surgery, measuring in days

  through study completion, an average of 15 days

• Tracheotomy

  need to do a tracheotomy during or after the surgery, qualitative outcome (yes or no)

  through study completion, an average of 15 days

• Hospitalisation time

  Duration of the whole hospitalisation in the ENT unit, measuring in days

  through study completion, an average of 15 days

Secondary Outcomes (4)

• Swallowing assessment with the Functional Oral Intake Scale

  through study completion, an average of 2 years

• Aesthetic evaluation

  through study completion, an average of 2 years

• Quality of Life assessment using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (version 3.0) and European Organisation for Research and Treatment of Cancer Head & Neck 43 questionnaires.

  through study completion, an average of 2 years

• Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

  through study completion, an average of 2 years

Study Arms (1)

patients studied

patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapular flap reconstruction

Eligibility Criteria

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

Study Population

all patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapula tip flap reconstruction between January 2015 and July 2023 in the Ear-Nose-Throat (ENT) department of Croix Rousse Hospital in Lyon, France.

You may qualify if:

• Patient with maxillary sinus tumor
• Treated by maxillectomy with free scapula tip flap reconstruction
• years of age or older

You may not qualify if:

• Reconstruction failure
• Carcinomatous recurrence and/or further progression impacting quality of life
• Death

Sponsors & Collaborators

• Hôpital de la Croix-Rousse: lead

Study Sites (1)

Croix Rousse Hospital

Lyon, 69004, France

Location

Study Officials

• Carine FUCHSMANN

  Hospice Civil de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: June 30, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-02

Locations

FR (1)