Clinical trial NCT06143280: Functional Soft Palate Reconstruction
Official title: Functional Soft Palate Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Palate Reconstruction
Keywords: swallowing phase
digastric muscle
palatal reconstruction
free radial flap plasty
displacement of the digastric muscle
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective study of all patients who have undergone reconstruction of the soft palate with free radial flap plasty in combination with displacement of the digastric muscle between 2007 and 2017 at the University Hospital Basel.

Brief summary: The aim of the study is to show that the innovative, dynamic palatal reconstruction technique (free radial flap plasty in combination with displacement of the digastric muscle) leads to a good functional outcome in terms of speech and swallowing in the context of the current literature.

Detailed description: Tumors in the throat and pharynx are common and often lead to impaired swallowing and phonation after surgical tumor resection. The posterior part of the digastric muscle is responsible for sealing during the pharyngeal swallowing phase, among other things. By relocating the digastric muscle, a defect in the area of the soft palate can now be reconstructed with a muscle whose physiological function is already integrated into the complex process of the swallowing act and thus leads to a better seal. This new, previously undescribed reconstruction option has been used on various patients at the University Hospital with good functional results.

This study is to describe the new dynamic technique for soft palate reconstruction and to analyze the associated functional and surgical outcomes including postoperative complications, speech and swallowing function. The resulting values will be compared with the existing literature. The aim is to investigate whether the functional outcome in terms of phonation and swallowing can be improved by this technique.

Eligibility criteria: Inclusion Criteria:

* Patients after tumor resection of the soft palate with reconstruction by a free radial flap and displacement of the digastric muscle.

Exclusion Criteria:

* Patients with resected oropharyngeal carcinoma but without reconstruction using the dynamic technique described are excluded from the study.

Primary outcomes:
measure: Number of complications
timeFrame: one time assessment at baseline
measure: Number of risk factors
timeFrame: one time assessment at baseline
measure: Number of perioperative therapies (chemotherapy and radiotherapy)
timeFrame: one time assessment at baseline
measure: Rate of different surgical indications
timeFrame: one time assessment at baseline
measure: Oncological status according to tumor, node, metastasis (TNM) classification
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
Study officials:
affiliation: Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
name: Dirk J. Schaefer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: