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.
Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.
Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0).
Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon.
Patient OMS 0-1.
Patient with history of prior cervical surgery and/or radiation to the head and neck.
History of pelvic surgery and/or radiation to the pelvic area.
Patients with a contraindication to any form of sedation.
Patient with irreversible coagulopathy.
Single group
Oropharyngeal or oral cavity reconstruction
Procedure/SurgeryOropharyngeal 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.
The 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.
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
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).
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).
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