CompletedNot Applicable

Collagen Matrix in Oral Cancer Surgery

France33 participantsStarted 2020-11-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Swallowing evaluation

Timeframe: From enrollment (the day before the surgery) to 6 months postoperatively.

Voice evaluation

Timeframe: From enrollment (the day before the surgery) to 6 months postoperatively.

Trial details

NCT IDNCT07337122

SponsorSAYAH Charline

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer trials