NCT05757817Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Feb 2023
- Start date
- 8 Nov 2023
- Primary completion date
- May 2026
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Head and neck cancer
- NCT number
- NCT05757817
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 8 Nov 2023 to the primary completion date, May 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with history of prior cervical surgery and/or radiation to the head and neck.
- Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose \> 10 mg of prednisone or equivalent) or other immunosuppressive therapy.
Other illness
- History of pelvic surgery and/or radiation to the pelvic area.
- 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.
- Patient with diabetes (type 1 or 2).
- 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 .
Other
- Patients with a contraindication to any form of sedation.
- Patient with irreversible coagulopathy.
- Patient with a contraindication to a CT scan or an injection of iodinated contrast medium.
- Pregnant or breastfeeding women.
- Patient with a BMI \> 30kg/m².
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Who the study is looking for
- 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.
- Age ≥ 18.
- Patient with no contraindication to surgery.
- Patient affiliated to a Social Health Insurance in France.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Gui de Chauliac Coordinator of this site? Confirm its status | Montpellier | France | Not yet recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHU Purpan Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O) Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.