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

Launched by INSTITUT CLAUDIUS REGAUD · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new surgical technique called the external pudendal flap, which aims to help patients with head and neck cancers, specifically those affecting the oral cavity and oropharynx. The study will assess how safe and effective this procedure is for reconstructing areas affected by cancer surgery. Up to 40 patients will participate, and they will be divided into two groups based on gender. The trial will follow each patient for 12 months after their surgery to monitor any complications and how well they recover.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of head and neck squamous cell carcinoma. They should also be in good health with no major medical issues that could complicate surgery. Participants will need to agree to follow the study's guidelines and give their consent before starting. In addition to the main trial, there will be an observational study involving 250 patients to gather more information about how well the new technique is accepted by patients. This trial is currently recruiting participants, and all interested individuals should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.
• • 2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0).
• • 3. Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon.
• • 4. Patient OMS 0-1.
• • 5. Age ≥ 18.
• • 6. Patient with no contraindication to surgery.
• • 7. Patient affiliated to a Social Health Insurance in France.
• • 8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
• Exclusion Criteria:
• • 1. Patient with history of prior cervical surgery and/or radiation to the head and neck.
• • 2. History of pelvic surgery and/or radiation to the pelvic area.
• • 3. Patients with a contraindication to any form of sedation.
• • 4. Patient with irreversible coagulopathy.
• • 5. Patient with a contraindication to a CT scan or an injection of iodinated contrast medium.
• • 6. Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose \> 10 mg of prednisone or equivalent) or other immunosuppressive therapy.
• • 7. Pregnant or breastfeeding women.
• • 8. Patient with another co-existing malignancy at the time of inclusion or any other significant medical, psychiatric, or surgical condition currently not controlled by treatment, which may interfere with the conduct of the study.
• • 9. Patient with diabetes (type 1 or 2).
• • 10. Patient with a BMI \> 30kg/m².
• • 11. Any psychological, family, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in the study protocol .
• • 12. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).