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
NCT ID: NCT05757817
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-08
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient with an ORL Cancer
Oropharyngeal or oral cavity reconstruction
Oropharyngeal or oral cavity reconstruction will be performed using a free super thin external pudendal artery flap (STEPA flap).
Post-operative follow-up and adjuvant treatment: Post-operative follow-up of patients will be performed according to the standards of the participating centers.
Interventions
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Oropharyngeal or oral cavity reconstruction
Oropharyngeal or oral cavity reconstruction will be performed using a free super thin external pudendal artery flap (STEPA flap).
Post-operative follow-up and adjuvant treatment: Post-operative follow-up of patients will be performed according to the standards of the participating centers.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Chu Gui de Chauliac
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Chu Purpan
Toulouse, , France
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22VADS02
Identifier Type: -
Identifier Source: org_study_id
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