Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae

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.

NCT Number	NCT05757817
Lead Sponsor	Institut Claudius Regaud
Conditions	Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
Enrollment	40 participants
Start Date	2023-11-08
Primary Completion	2026-05 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-15