Collagen Matrix in Oral Cancer Surgery

NCT07337122 | Completed

• 1 other identifier: 2020/104
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

oral cancer; phonation; swallowing; voice; glossectomy; reconstruction; tachosil

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (3)

• Length of hospital stay

  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

  From the surgery up to two weeks.

• incidence and onset of device-related complications

  From the day of the surgery to one week after

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SAYAH Charline: lead

Study Sites (1)

Universitary Hospital of Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr SAYAH Charline

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 13, 2026
• Study Start: November 16, 2020
• Primary Completion: October 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

FR (1)