Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction

Total or Subtotal Maxillectomy with Scapular Free Flap Reconstruction: Airway Management, Aesthetic and Functional Results

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

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus Squamous Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Croix Rousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients studied; patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapular flap reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing assessment with the Functional Oral Intake Scale	Swallowing was assessed using the Functional Oral Intake Scale (FOIS). Scores ranged from one (no oral intake) to seven (normal diet with no change in texture), with a high score indicating good swallowing function.	through study completion, an average of 2 years
Aesthetic evaluation	A subjective patient assessment of the aesthetic result was carried out using the appearance subcategory of the University of Washington Quality of Life Questionnaire (UW-QOL v4). There are five possible responses, each scored at 0, 25, 50, 75 and 100. A score of 0 represents the worst possible aesthetic result, and a score of 100 the best possible result.	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.	The QLQ-C30 is a general quality-of-life questionnaire specific to oncological pathology and intended for all cancer patients regardless of location. It comprises a central questionnaire for assessing 5 functions (physical, cognitive, social, limitations in daily activities and psychological), 9 symptoms and overall health. To this questionnaire can be added modules specific to a cancer site, such as the EORTC QLQ-H&N43 for head and neck cancers. Responses to both questionnaires are then transformed to produce a score ranging from 0 to 100. For the functional scales and the global health scale, a high score represents a good level of functioning, while a high score on the symptom scales indicates a high level of symptoms and/or problems.	through study completion, an average of 2 years
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	Functional assessment of the upper limb was performed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. This is a subjective self-assessment questionnaire of the overall functional capacity of both upper limbs. The score ranges from 0 to 100. Higher scores indicate an inability to perform tasks, great difficulty in doing them, or significant symptoms.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Hôpital de la Croix-Rousse
• Investigators: Principal Investigator: Carine FUCHSMANN, Hospice Civil de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Reconstruction; Functional; Tracheotomy; Scapula; Aesthetic; Maxillectomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
• Other Study ID Numbers: 2023-05-022-CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No