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 (LAMBEAU STEPA)

September 11, 2025 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with an ORL Cancer
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of a limiting complication. Limiting complications are defined as total flap necrosis (flap failure) or donor site infection (Fournier Gangrene) within 4 weeks of the experimental procedure.
Time Frame: 4 weeks for each patient
4 weeks for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5
Time Frame: 12 months for each patient
12 months for each patient
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).
Time Frame: 12 months for each patient
12 months for each patient
The functional capacity of swallowing will be assessed via the Performance Status Scale for Head and Neck cancer patients - PSS-HN (Scales are: Normalcy of Diet, Public Eating, and Understandability of Speech).
Time Frame: 12 months for each patient
12 months for each patient
4. The aesthetic evaluation will be performed according to a Likert scale (Likert scale: not at all satisfied, somewhat not satisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied).
Time Frame: 12 months for each patient
12 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22VADS02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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