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Functional Soft Palate Reconstruction

Functional Soft Palate Reconstruction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06143280
Enrollment
10
Registered
2023-11-22
Start date
2023-11-06
Completion date
2024-11-30
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Palate Reconstruction

Keywords

swallowing phase, digastric muscle, palatal reconstruction, free radial flap plasty, displacement of the digastric muscle

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.

Interventions

OTHERData 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of different surgical indicationsone time assessment at baselineSurgical indication in patients with reconstruction of the soft palate (descriptive)
Number of complicationsone time assessment at baselineNumber of complications after reconstruction of the soft palate with free radial flap plasty in combination with displacement of the digastric muscle
Number of risk factorsone time assessment at baselineNumber of risk factors in patients with reconstruction of the soft palate
Number of perioperative therapies (chemotherapy and radiotherapy)one time assessment at baselinePerioperative therapies (chemotherapy and radiotherapy) in patients with reconstruction of the soft palate (descriptive)
Oncological status according to tumor, node, metastasis (TNM) classificationone time assessment at baselineOncological 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.)

Countries

Switzerland

Contacts

Primary ContactDirk J. Schaefer, Prof. Dr. med.
dirk.schaefer@usb.ch+41 61 265 73 49
Backup ContactAnne Springer, Ph.D.
anne.springer@usb.ch+41 61 556 50 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026