Actively Recruiting
Evaluation of a New Surgical Procedure Using the External Pudendal Flap for Oral Cavity and Oropharyngeal Reconstruction in Head and Neck Cancer Patients According to IDEAL Recommendations
Led by Institut Claudius Regaud · Updated on 2025-09-15
40
Participants Needed
4
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 of the oral cavity or oropharynx
- Disease stage T0-4a N0/N2c M0 according to UICC TNM 8th edition
- Requirement for free fasciocutaneous flap reconstruction as determined by an experienced oncology surgeon
- Performance status OMS 0-1
- Age 18 years or older
- No contraindication to surgery
- Affiliated to a Social Health Insurance in France
- Able and willing to provide 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 medium injection
- Active autoimmune disorders requiring immunosuppressive therapy (steroids over 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 over 30 kg/m²
- Psychological, family, geographic, or social conditions preventing compliance with follow-up
- Legal protection status restricting freedom (curatorship, guardianship, protection of justice)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 4 weeks
Participants undergo oropharyngeal or oral cavity reconstruction using a free super thin external pudendal artery flap (STEPA flap) followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months
Participants are followed post-operatively according to the standards of the participating centers to monitor complications, pain, functional capacity of swallowing, and aesthetic outcomes.
Multiple visits over 12 months for assessments
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
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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