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Completed

NCT Number: NCT07337122

Collagen Matrix in Oral Cancer Surgery

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.

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Key information

Conditions

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Oropharynx Cancer Oropharynx Squamous Cell Carcinoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitary Hospital of Besancon

Besançon, 25000, France

About this study

It was an interventional study with a single Group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Length of hospital stay

    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.

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

  2. time to oral feeding resumption

    Time frame: 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.

  3. incidence and onset of device-related complications

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

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

Sponsors and collaborators

Lead sponsor

SAYAH Charline

Other

Registry information

Official study title

Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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