Clinical trial · Observational
Collagen Matrix in Oral Cancer Surgery
Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery
NCT07337122CI-TRIAL-00100761completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Case group
- description
- 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
Primary outcomes (2)
- measure
- Swallowing evaluation
- timeFrame
- From enrollment (the day before the surgery) to 6 months postoperatively.
- description
- 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.
- measure
- Voice evaluation
- timeFrame
- From enrollment (the day before the surgery) to 6 months postoperatively.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.