Collagen Matrix in Oral Cancer Surgery

NCT ID: NCT07337122

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-16

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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It was an interventional study with a single Group.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SAYAH Charline

OTHER

Sponsor Role lead

Responsible Party

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SAYAH Charline

Dr SAYAH Charline

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitary Hospital of Besancon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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2020/104

Identifier Type: -

Identifier Source: org_study_id

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