Functional Results of Soft Palate Free Flap Reconstruction (RECaVoLL)

Civil Hospices of Lyon

Status

Completed

Conditions

Oropharyngeal Cancer

Palate Free Flap Reconstruction

Treatments

Other: Evaluation of swallowing quality

Other: global quality of life questionnaire

Other: Evaluation of phonation quality

Study type

Observational

Funder types

Other

Identifiers

NCT03890783

69HCL18_0826

2018-A03408-47 (Other Identifier)

Details and patient eligibility

About

The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation.

The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.

Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.

It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.

There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with oropharyngeal tumor who had surgical management with removal of all or part of the soft palate and free flap reconstruction, and at least 12 month after the end of external radiotherapy treatment
Patients over 18 years old

Exclusion criteria

Patients protected by law (guardianship, curatorship and under judicial protection)
Patients who expressed their opposition to participate to the study
Patients who do not speak French (incompatible with reading, understanding and filling out the questionnaires)
Patients participating in interventional research (excluding physiological studies and interventional research with minimal risks and constraints that do not interfere with the primary endpoint analysis)