laryngectomy low skeletal muscle mass
Conditions
Interventions
PMMF flap in TL patients with low SMM randomized for intervention arm
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Planned for TL • Eighteen years of age or older, and able to exercise their free will. • Sufficient understanding of the Dutch language to give informed consent.
Exclusion criteria
Exclusion criteria: - Planned for TL with pharyngectomy and reconstruction of the pharynx with PMMC. - Planned TL with pharyngectomy and reconstruction with jejunal flap or gastric pull-up. - Planned TL after treatment with chemoradiotherapy (cisplatin/carboplatin) for a previously diagnosed head and neck carcinoma - Major (FDG-PET/)CT or MRI artefacts, impeding accurate muscle tissue identification on imaging. - Interval between TL and imaging > 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In a randomized clinical trial the addition of PMMF as onlay for reinforcement in low SMM patients will be investigated. Patients who are planned for TL without PMMC for reconstruction of the mucosal defect will be asked to participate in this study. After informed consent SMM will be measured using routinely performed CT or MRI of the head and neck. Patients with low SMM will be randomized between PMMF reconstruction at the time of TL or not. Incidence of PCF will be scored for the three groups: patients with low SMM with PMMF as onlay for reinforcement, patients with low SMM without PMMF and patients without low SMM. It is hypothesized that the use of PMMF can reduce the PCF rate to a level similar to TL patients without low SMM. Skeletal muscle mass measurement SMM is measured on pre-treatment CT or MRI scans of the head and neck area at the level of C3 using a previously published method. Whenever possible, CT imaging was used instead of MRI. In brief, the first slide at the level of C3 when scrolling from caudal to cranial direction to show both transverse processes and the entire vertebral arc is selected for segmentation of skeletal muscle (SM) tissue. For CT imaging, skeletal mass (SM) area is defined as the pixel area within a radiodensity between -29 and +150 Hounsfield Units (HU), which is specific for SM tissue. For MRI, SM tissue is carefully segmented and any intramuscular fatty tissue is manually excluded. Segmentation of SM tissue was manually performed using in house or commercially available software package SliceOmatic (Tomovision, Canada). An example of SM tissue segmentation at the level of C3 is shown in Figure 1. After a learning period, the measurement of SMM requires 5 to 10 minutes per CT scan, and up to 15 minutes per MRI scan. From SM area at C3, SM area at the level of L3 is predicted using the previously published Formula 1. The SM area at L3 is then normalized for height to calculate the lumbar skeletal muscl | — |
Secondary
| Measure | Time frame |
|---|---|
| All patients are asked to fill out the questionnaires, but performing function tests will be dependent on the ability in each participating center. At least in 3 centers the following function tests will be performed: patients with low SMM will be tested for shoulder and neck disability, swallowing function and voice quality. Also patients with secondary (for PCF treatment) PM flap will undergo these tests. Sub analysis will be performed to investigate if there is a difference in morbidity between prophylactic and secondary PM flap harvest. Shoulder and neck function Questionnaires (secondary study parameter) The shoulder disability questionnaire (SDQ) is a validated pain-related disability questionnaire including 16 items that describe common conditions that may induce symptoms in patients with disorders of the shoulder. All items refer to the preceding 24 hours. Options are *yes*, *no* and *not applicable*. The *not applicable* category should be used when the condition referred to has not occurred during the preceding 24 hours. A final score is calculated dividing the number of *yes* scored items by the total number of items applicable. And then multiplying the score by 100 results in a final score that ranges between 0 (no disability) and 100 (all applicable items scored *yes*). The higher the score, the greater the impairment was. All patients are asked to fill out the questionnaires for both the left and the right shoulder separately. Shoulder function will also be measured with the Shoulder Pain and Disability Index Dutch Language Version (SPADI-DLV). This questionnaire consists of 13 items, 5 related to pain and 5 related to function. Pain of the shoulder is rated on a visual analogue scale (VAS: 0-100 millimeter). Patients are asked to indicate the mean shoulder pain intensity over the past week. Patients are also asked if they had experienced stiffness of the shoulder during the previous week (yes or no). The Neck Disability In | — |
Countries
Belgium, Netherlands
Contacts
Public ContactMA Beers
Universitair Medisch Centrum Utrecht
Outcome results
None listed