Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- SAYAH Charline
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Swallowing evaluation
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Case group
Patient were ≥18 years with a histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx with surgical resection indicated (T1-T3). The performance status was betwen 0 and 2. Patients were receiving or not receiving postoperative adjuvant radiotherapy
Outcomes
Primary Outcomes
Swallowing evaluation
Time Frame: 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
Time Frame: 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 Outcomes
- 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.)
- time to oral feeding resumption(From the surgery up to two weeks.)
- incidence and onset of device-related complications(From the day of the surgery to one week after)
Investigators
SAYAH Charline
Dr SAYAH Charline
Hôpital de la Croix-Rousse