Collagen Matrix in Oral Cancer Surgery

SAYAH Charline

Status: Completed

Conditions: Oropharynx Cancer; Oropharynx Squamous Cell Carcinoma; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07337122

2020/104

Details and patient eligibility

About

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.

Full description

It was an interventional study with a single Group.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Case group

Description:

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