Collagen Matrix in Oral Cancer Surgery

January 6, 2026 updated by: SAYAH Charline

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

Study Overview

Status

Completed

Conditions

Detailed Description

It was an interventional study with a single Group.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • Universitary Hospital of Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants were selected among patients presenting to the ENT department of the University Hospital of Besançon for a suspected lesion of the oral cavity or oropharynx.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment (the day before the surgery) to 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.
From enrollment (the day before the surgery) to 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
From the surgery up to two weeks.
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.
From the day of the surgery to one week after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SAYAH Charline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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