Functional Soft Palate Reconstruction

Recruiting

• Conditions: Soft Palate Reconstruction

• Registration Number: NCT06143280
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-06
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of risk factors	one time assessment at baseline	Number of risk factors in patients with reconstruction of the soft palate
Number of perioperative therapies (chemotherapy and radiotherapy)	one time assessment at baseline	Perioperative therapies (chemotherapy and radiotherapy) in patients with reconstruction of the soft palate (descriptive)
Number of complications	one time assessment at baseline	Number of complications after reconstruction of the soft palate with free radial flap plasty in combination with displacement of the digastric muscle
Rate of different surgical indications	one time assessment at baseline	Surgical indication in patients with reconstruction of the soft palate (descriptive)
Oncological status according to tumor, node, metastasis (TNM) classification	one time assessment at baseline	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.)

Trial Locations

Locations (1)

Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel; 🇨🇭 Basel, Switzerland