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Completed

NCT Number: NCT06865313

Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction

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

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Key information

Conditions

Maxillary Sinus Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix Rousse Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. time to resumption of oral feeding

    Time frame: through study completion, an average of 15 days

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

  2. duration of hospitalization in a continuing care unit

    Time frame: through study completion, an average of 15 days

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

  3. Tracheotomy

    Time frame: through study completion, an average of 15 days

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

  4. Hospitalisation time

    Time frame: through study completion, an average of 15 days

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

Secondary outcomes

  1. Swallowing assessment with the Functional Oral Intake Scale

    Time frame: 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.

  2. Aesthetic evaluation

    Time frame: 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.

  3. 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.

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hôpital de la Croix-Rousse

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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