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Functional Soft Palate Reconstruction

NCT ID: NCT06143280

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Soft Palate Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Data collection

Data collection using entries in the medical records of the respective patients (surgery reports, progress notes, consultation reports, imaging and pathology reports) who underwent surgery with the new dynamic technique for soft palate reconstruction.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk J. Schaefer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel

Locations

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Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dirk J. Schaefer, Prof. Dr. med.

Role: CONTACT

[email protected]
+41 61 265 73 49

Anne Springer, Ph.D.

Role: CONTACT

[email protected]
+41 61 556 50 49

Facility Contacts

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Dirk J. Schaefer, Prof. Dr. med.

Role: primary

[email protected]
+41 61 265 73 49

Other Identifiers

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2023-01689; mu23Schaefer2

Identifier Type: -

Identifier Source: org_study_id