Oral Cavity Defect, Oropharynx Defect
Conditions
Keywords
reconstruction with a free reinnervated profunda artery perforator flap, sensory recovery
Brief summary
The aim of this study is to investigate sensory recovery and functional outcomes following oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery perforator) flaps.
Detailed description
Tumor resections involving the oral cavity or oropharynx cause significant functional deficits in swallowing and speech and subsequently impair the patients' quality of life. The anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior sensory recovery, improved swallow function, and improved overall patient satisfaction in patients with reinnervated flaps compared with patients who received ALT flap reconstruction without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been proposed as an alternative donor site in malnourished patients with thin lateral thigh thickness. However, reinnervation of PAP flaps has not been described. The study assesses sensory recovery after defect reconstruction with the reinnervated profunda artery perforator flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing, two-point discrimination, temperature, pain perception)
Interventions
PROCEDURESurgical reconstruction
Surgical reconstruction with a free reinnervated profunda artery perforator flap
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective case series (pilot study)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap
Exclusion criteria
* \<18 years old * Defect localizations other than the oral cavity or oropharynx * Not able to give informed consent * Inability to follow the procedures of the study, e.g., due to psychological disorders, dementia * Inability or contraindications to undergo the investigated intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Semmes-Weinstein monofilament testing | before surgery and 3, 6 and 12 month after surgery | The Semmes-Weinstein Monofilament test is a sensory assessment tool. This assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments ranges from .086 gm to 448gm. These monofilaments are used to map out sensory loss or recovery. Semmes-Weinstein monofilament testing will be performed at the tip (distal 1 cm) and the dorsum of the reconstructed flap/neo-tongue. Semmes-Weinstein monofilament testing will also be performed in the profunda artery perforator flap territory on the ipsilateral and contralateral thigh. For this purpose, the investigators will use the Baseline FoldUp Monofilament Evaluator Set with Case. |
| Change in two-point discrimination test | before surgery and 3, 6 and 12 month after surgery | The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It will be measured using Dellon Disk Criminator |
| Change in temperature perception | before surgery and 3, 6 and 12 month after surgery | Hot (50 degrees Celsius) and cold (4 degrees Celsius) temperature perception will be assessed by use of a small test tube filled with water at the appropriate temperatures. |
| Change in pain perception | before surgery and 3, 6 and 12 month after surgery | Pain perception will be assessed with a 27-gauge needle. |
Countries
Switzerland
Contacts
Primary ContactNicole E. Speck, Dr. med.
Backup ContactDirk J. Schaefer, Prof. Dr.
Outcome results
None listed