Evaluation of the Benefit of a New Surgical Procedure Acc... | NCT05757817

Studies
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

NCT05757817

Sponsor

Institut Claudius Regaud

Status

Recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Head and Neck Cancer
Oral Cavity Cancer
Oropharynx Cancer

Interventions

Oropharyngeal or oral cavity reconstruction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2023Actual

Primary Completion Date

May 2026Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Feb 24, 2023

First Submission Date that Met QC Criteria

Feb 24, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 15, 2025Actual

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with an ORL Cancer	Experimental		Procedure: Oropharyngeal or oral cavity reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oropharyngeal or oral cavity reconstruction	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	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.		4 weeks for each patient

Secondary Outcomes

Measure	Description	Time Frame
The postoperative complications will be evaluated according to the NCI-CTCAE version n°5		12 months for each patient
The pain will be assessed according to a Likert scale between 0 (no pain) and 10 (worst pain).		12 months for each patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patient with history of prior cervical surgery and/or radiation to the head and neck.
History of pelvic surgery and/or radiation to the pelvic area.
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.
Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose > 10 mg of prednisone or equivalent) or other immunosuppressive therapy.
Pregnant or breastfeeding women.
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).
Patient with a BMI > 30kg/m².
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 .
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006258	Head and Neck Neoplasms
D009062	Mouth Neoplasms
D009959	Oropharyngeal Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases