Study of a New Surgical Reconstruction Using External Pudendal Flap for Oral Cavity and Oropharynx Cancer Patients Following IDEAL Guidelines to Reduce Donor Site Complications

What this Trial Is About

Researchers are evaluating a new surgical technique using the external pudendal free flap for reconstruction of the oral cavity or oropharynx in patients with head and neck squamous cell carcinoma. This phase 1b, multicenter, non-randomized study includes an innovation phase IDEAL-1 focused on the safety and feasibility of the procedure, followed by a development phase IDEAL-2A to describe the complication profile in male and female patients. Up to 40 patients will be enrolled, with follow-up lasting 12 months after completion of surgery and any additional treatment. The procedure involves reconstructing the oral cavity or oropharynx using a free super thin external pudendal artery flap STEPA flap. Postoperative care and any adjuvant treatments will follow the standards of participating centers. The study has two stages the first assesses surgical feasibility and limits complications, while the second evaluates the types and frequency of postoperative complications in both patient groups. Participants will be monitored for surgical complications such as total flap failure or donor site infections within the first 4 weeks. Longer-term assessments over 12 months will include pain levels, swallowing function using the Performance Status Scale for Head and Neck cancer patients, aesthetic satisfaction, and postoperative complications graded by standard criteria. A complementary observational study of 250 patients will also assess patient acceptability of this reconstruction technique.

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