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Understanding Non-radiotherapy-based Development of Trismus

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Oral Cancer
Trismus

Treatments

Diagnostic Test: ultrasound of the masseteric muscle

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.

The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.

The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients with a newly diagnosed oral cancer.
  • Cases with a limited mouth opening secondary to oral tumour resections

Exclusion criteria

  • Minors.
  • Deceased cases within the follow-up period of one year.
  • Other malignancies than oral squamous cell carcinomas.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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