Collagen Matrix in Oral Cancer Surgery

SAYAH Charline33 enrolled

Overview

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.

It was an interventional study with a single Group.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer Oropharynx Squamous Cell Carcinoma Oropharynx Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitary Hospital of Besancon

Besançon, France

Outcomes

Primary Outcomes

Swallowing evaluation

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.

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

Voice evaluation

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.

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

Secondary Outcomes

Length of hospital stay

We evaluate the length of hospital stay, it was expressed in days as mean and standard deviation

Time frame: 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

Number of days between the surgery and the time the patient start to eat again by the mouth.

Time frame: From the surgery up to two weeks.

incidence and onset of device-related complications

Incidence of immunologic reaction to the collagen matrix (tachosil). Expressed in number and pourcentage.

Time frame: From the day of the surgery to one week after

Data from ClinicalTrials.gov

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