Functional Soft Palate Reconstruction

NCT06143280 | Unknown

• 1 other identifier: 2023-01689; mu23Schaefer2
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Palate Reconstruction

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Data collection OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dirk J. Schaefer, Prof. Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk J. Schaefer, Prof. Dr. med.

CONTACT

+41 61 265 73 49; dirk.schaefer@usb.ch

Anne Springer, Ph.D.

CONTACT

+41 61 556 50 49; anne.springer@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: November 6, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CH (1)