Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma
Conditions
Keywords
oral cancer, phonation, swallowing, voice, glossectomy, reconstruction, tachosil
Brief summary
This study tend to evaluate postoperative phonation and swallowing after oncologic surgery of the oral cavity or oropharynx with application of a collagen matrix (Tachosil®). Patients are asked to complete a questionnaire the day before the surgery and at 1 and 6 months after.
Detailed description
It was an interventional study with a single Group.
Interventions
None listed
Sponsors
SAYAH Charline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx * Performance status (PS) 0-2 * Tumor stages for which surgical resection was indicated (T1-T3) * Patients receiving or not receiving postoperative adjuvant radiotherapy
Exclusion criteria
* Legal incapacity or limited legal capacity * Inability or anticipated poor compliance with study procedures * Missing questionnaire data * Congenital or acquired swallowing disorders (neurological or neuromuscular disease) * Congenital or acquired speech disorders (neurological or neuromuscular disease) * Death during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing evaluation | From enrollment (the day before the surgery) to 6 months postoperatively. | We use the Deglutition Handicap Index questionnaire to evaluative swallowing before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively. |
| Voice evaluation | From enrollment (the day before the surgery) to 6 months postoperatively. | We use the Voice Handicap Index questionnaire to evaluate the phonatione before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From the day before the surgery up to 3 weeks after surgery. The number of days between hospital admission and discharge to home was calculated. | We evaluate the length of hospital stay, it was expressed in days as mean and standard deviation |
| time to oral feeding resumption | From the surgery up to two weeks. | Number of days between the surgery and the time the patient start to eat again by the mouth. |
| incidence and onset of device-related complications | From the day of the surgery to one week after | Incidence of immunologic reaction to the collagen matrix (tachosil). Expressed in number and pourcentage. |
Countries
France
Outcome results
None listed