Actively Recruiting
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
Led by Institut Claudius Regaud · Updated on 2025-09-15
40
Participants Needed
4
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.
- Disease classified as UICC TNM stage (8th edition): T0-4a N0/N2c M0 (no distant metastasis).
- Reconstruction of the oral cavity or oropharynx requires a free fasciocutaneous flap as determined by an experienced oncology surgeon.
- Patient has an OMS performance status of 0 or 1.
- Age 18 years or older.
- No contraindications to surgery.
- Affiliated with French Social Health Insurance.
- Able to participate, willing to give informed consent, and comply with study protocol.
You will not qualify if you...
- History of prior cervical surgery or radiation to the head and neck.
- History of pelvic surgery or radiation to the pelvic area.
- Contraindication to any form of sedation.
- Irreversible coagulopathy.
- Contraindication to CT scan or iodinated contrast injection.
- Active autoimmune disorders requiring immunosuppressive therapy (steroids >10 mg prednisone or equivalent).
- Pregnant or breastfeeding women.
- Presence of another malignancy or significant uncontrolled medical, psychiatric, or surgical condition.
- Diabetes mellitus type 1 or 2.
- Body mass index (BMI) greater than 30 kg/m².
- Psychological, family, geographic, or sociological conditions preventing compliance with follow-up or study procedures.
- Legal restrictions such as loss of freedom or legal protection (curatorship, guardianship).
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Chu Gui de Chauliac
Montpellier, France
Not Yet Recruiting
2
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
3
Chu Purpan
Toulouse, France
Not Yet Recruiting
4
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, France
Actively Recruiting
Research Team
A
Agnès DUPRET-BORIES
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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