Maxillary Sinus Squamous Cell Carcinoma
Conditions
Keywords
Maxillectomy, Reconstruction, Scapula, Tracheotomy, Functional, Aesthetic
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
Interventions
None listed
Sponsors
Hôpital de la Croix-Rousse
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalisation time | through study completion, an average of 15 days | Duration of the whole hospitalisation in the ENT unit, measuring in days |
| time to resumption of oral feeding | through study completion, an average of 15 days | time to resumption of oral feeding after the surgery, measuring in days |
| duration of hospitalization in a continuing care unit | through study completion, an average of 15 days | hospitalization in a continuing care unit after the surgery, measuring in days |
| Tracheotomy | through study completion, an average of 15 days | need to do a tracheotomy during or after the surgery, qualitative outcome (yes or no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing assessment with the Functional Oral Intake Scale | through study completion, an average of 2 years | 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. |
| Aesthetic evaluation | through study completion, an average of 2 years | 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. |
| 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 | 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. |
| Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | through study completion, an average of 2 years | 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. |
Countries
France
Outcome results
None listed