This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the external pudendal free flap in two groups of patients. A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A phase study. Stage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female). Stage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations. Each patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment). A complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Oropharyngeal or oral cavity reconstruction will be performed using a free super thin external pudendal artery flap (STEPA flap). Post-operative follow-up and adjuvant treatment: Post-operative follow-up of patients will be performed according to the standards of the participating centers.
Chu Gui de Chauliac
Montpellier, France
NOT_YET_RECRUITINGCentre Antoine Lacassagne
Nice, France
RECRUITINGChu Purpan
Toulouse, France
NOT_YET_RECRUITINGInstitut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, France
RECRUITINGThe occurrence of a limiting complication. Limiting complications are defined as total flap necrosis (flap failure) or donor site infection (Fournier Gangrene) within 4 weeks of the experimental procedure.
Time frame: 4 weeks for each patient
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
Time frame: 12 months for each patient
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
Time frame: 12 months for each patient
The functional capacity of swallowing will be assessed via the Performance Status Scale for Head and Neck cancer patients - PSS-HN (Scales are: Normalcy of Diet, Public Eating, and Understandability of Speech).
Time frame: 12 months for each patient
4. The aesthetic evaluation will be performed according to a Likert scale (Likert scale: not at all satisfied, somewhat not satisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied).
Time frame: 12 months for each patient
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