Functional Soft Palate Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Palate Reconstruction
• Intervention / Treatment: Other: Data collection

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Dirk J. Schaefer, Prof. Dr. med.; Phone Number: +41 61 265 73 49; Email: dirk.schaefer@usb.ch
• Study Contact Backup: Name: Anne Springer, Ph.D.; Phone Number: +41 61 556 50 49; Email: anne.springer@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
    • Contact: Dirk J. Schaefer, Prof. Dr. med.; Phone Number: +41 61 265 73 49; Email: dirk.schaefer@usb.ch
    • Principal Investigator: Dirk J. Schaefer, Prof. Dr. med.
    • Sub-Investigator: Sofia Oetliker-Contin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications	Number of complications after reconstruction of the soft palate with free radial flap plasty in combination with displacement of the digastric muscle	one time assessment at baseline
Number of risk factors	Number of risk factors in patients with reconstruction of the soft palate	one time assessment at baseline
Number of perioperative therapies (chemotherapy and radiotherapy)	Perioperative therapies (chemotherapy and radiotherapy) in patients with reconstruction of the soft palate (descriptive)	one time assessment at baseline
Rate of different surgical indications	Surgical indication in patients with reconstruction of the soft palate (descriptive)	one time assessment at baseline
Oncological status according to tumor, node, metastasis (TNM) classification	Oncological status in patients with reconstruction of the soft palate (descriptive); TNM classification system for carcinoma is to establish the anatomic extent of the disease (Stage 0 - Indicates carcinoma in situ. Tis, N0, M0. Stage I - Localized cancer. T1-T2, N0, M0. Stage II - Locally advanced cancer, early stages. T2-T4, N0, M0. Stage III - Locally advanced cancer, late stages. T1-T4, N1-N3, M0.; Stage IV - Metastatic cancer. T1-T4, N1-N3, M1.)	one time assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Dirk J. Schaefer, Prof. Dr. med., Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: swallowing phase; digastric muscle; palatal reconstruction; free radial flap plasty; displacement of the digastric muscle
• Other Study ID Numbers: 2023-01689; mu23Schaefer2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No