Reconstructive Surgery After Carcinological ExcisionNCT03677349
Evaluation of the Interest of the Neurorrhaphy in Resensitizing Free Flaps
A study testing neurorrhaphy in people with Reconstructive Surgery After Carcinological Excision, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgery After Carcinological Excision
- What is being tested?
- neurorrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2018to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Patient eligible for reconstructive surgery after carcinological excision following a decision taken in a multidisciplinary consultation, and for whom the envisaged oral defect concerns either the soft tissues of the oral cavity and oropharynx, or the mandibular bone
- Scheduled post-operative radiotherapy
- Coverage by the Social Security system
- Capacity to provide informed consent
Who cannot join
- Post-traumatic substance loss (ballistic autolysis)
- Surgical or anesthetic contraindication (physiological age, other proposed therapeutic options)
- Pregnant or breastfeeding woman
- Subject incapable of full age or deprived of liberty
- Indication for chemotherapy with highly neurotoxic agents
- Inability to complete questionnaires or express feelings during the examination
- Any situation judged by the investigator as a contraindication to neurorrhaphy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Arnaud DEPEYRE
About this study
Official title: Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing).
Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.
Read the detailed description
Investigator will compare patients in whom the nervous suture will be performed and patients in whom it will not. If a significant difference in oral sensitivity is noted between these 2 groups, investigator can support our thesis: suturing the flap nerve increases its ability to regain sensitivity.
All patients are first diagnosed in consultation and presented at a carcinologic multidisciplinary consultation during which an individually adapted treatment is proposed (according to the French "Plan Cancer"). If it consists in a surgery with reconstruction using free flap technique at the same time, Investigator then propose to the patient to integrate our study. The possibility to participate to this study is therefore proposed to the patient on the same day that the plan of treatment is presented. The patient has a period of reflection, minimal time necessary to mature his reflection and make their choice with their loved ones and decide if they agree to participate to the study. His answer is required the day before the surgery. This represents a reflection period of two weeks on average. If he accepts it, computer software (RedCap®) will determine at random if the surgical team will perform a nervous suture or not. As a result, two groups patients are then created: one with nervous suture and one with no nervous suture. By comparing these two groups, investigator hope to demonstrate that there will be more patients with a flap sensitive in the "with nerve suture" group than in the "without nerve suture" group.
Investigator will then collect data from tests and questionnaires allowing us to judge the resensitization of the flap during follow-up consultations at 3, 6 months then at 1 year postoperatively in parallel follow-up consultations. That is to say that the patient therefore comes for a consultation as part of his cancer follow up and investigator take advantage of this time to carry out tests and questionnaires. This adds about 20 minutes of consultation time.
A preoperative evaluation will be done before the surgery corresponding to the basal state calibration. During these consultations, investigator perform two tests and investigator will provide 2 quality of life questionnaires to fill out:
- The two-discriminating points test: two points are applied on the flap at different distances and the patient must indicate if he feels one or two points.
- The hot/cold test: hot water and cold water are applied on the flap separately, and the patient should indicate if he feels the temperature differences.
- The QLQ-C30 and EOTRC H\&N 35 questionnaires: several questions concerning the quality of life are asked to the patient who must answer them as honestly as possible.
After collecting all this information, investigator can compare the sensitivity of free flaps with or without nerve suture.
In parallel, investigator will also evaluate the economic impact and cost that this can represent by comparing the operating and hospitalization times of patients in each group. Investigator believe that the operating time is not increased nor the length of hospitalization and therefore that there is no additional cost.
- Being tested
- neurorrhaphy
- Keywords
- Oral cancer, Free Flap, Neurrorhaphy, Quality of life
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurorrhaphyProcedure or surgery
During the surgery, the flap is removed from its donor site, placed on the recipient site (instead of carcinological excision) and its survival is ensured by arterial and venous anastomosis (to the artery and facial vein or to the external carotid artery and thyro-linguofacial veinous trunk).
We then propose a reconstruction complement: nerve anastomosis (neurorrhaphy) to the lingual nerve for the antebrachioradial and anterolateral thigh flaps, and to the lower alveolar nerve for the fibular bone flaps. This supplement is performed during microsurgical time by a suture for the patient in group 1.
| Study group | Role | What they receive |
|---|---|---|
| Resensitized group | Experimental | Patients with resensitized free flap by neurorrhaphy Receives: Procedure: neurorrhaphy |
| Non Resensitized group | Experimental | Patients without resensitized free flap by neurorrhaphy. Receives: Procedure: neurorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicritic sensitivity measurement
It is a method of discriminating evaluation of epicritic sensitivity validated by the scientific literature
Measured: Before intervention (at day 1).
Thermoalgic sensitivity measurement
Thermoalgic resensitization measured by Hot test
Measured: Before intervention (at day 1)
Thermoalgic sensitivity measurement
Thermoalgic resensitization measured by cold test
Measured: Before intervention (at day 1)
Secondary outcomes (6)
Quality of life judged by QLQ-C30
The QLQ-C30 is a are self-administered questionnaire and validated by the European Organisation for Research and Treatment of Cancer assessing overall health status of patients. The QLQ-C30 focuses on patients' overall quality of life and disease experience
Measured: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
Quality of life judged by EOTRC H&N 35
The EORTC H\&N 35 questionnaires are self-administered and validated by the European Organisation for Research and Treatment of Cancer assessing overall health status of patients. The EORTC H\&N 35 focuses on mouth sensations and major oral functions such as chewing, phonation or swallowing
Measured: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
Voice Handicap Index
The VHI is a self-assessment scale (established by Jacobson et al., 1997) adapted in French that provides a psychometric inventory of vocal disability that can be used for a wide variety of conditions (Woisard et al., 2004). The higher the score is, the greater the feeling of disability. The VHI is rated on 120 points. For each question, the scale used is a Likert analog scale, a frequency variable rated from 0 to 4 (0=never; 1=almost never; 2=sometimes; 3=almost always; 4=always). Its three subscales are each composed of 30 assertions
Measured: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
The Deglutition Handicap Index
The DHI is a French self-administered questionnaire on the quality of life specific to swallowing. It was written and validated in 2006 by Woisard and Puech, based on the Voice Handicap Index (VHI) model (Crestani, Moerman et al.), (Woisard \& Lepage, 2010). It consists of three domains, each containing ten items:
Measured: 6 months post-surgery
Economic evaluation
The investigators collect the operating time and hospitalisation time for each patient to demonstrate that our operating technique does not generate any additional costs.
Measured: 1 month post-hospitalization
impact on the cost of the stay
The investigators collect the operating time and hospitalisation time for each patient to demonstrate that our operating technique does not generate any additional costs.
Measured: 1 month post-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start16 Jul 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgery After Carcinological ExcisionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of primary and secondary outcomes measures between group 1 (resensitization by neurorrhaphy) and group 2 patients (No resensitization by neurorrhaphy). Patients randomly included in the groups according to a randomization software (RedCap)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Aurillac
- Responsible party
- Sponsor
- Investigators
- Arnaud DEPEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677349
- Sponsor's protocol ID
- CHU-392
- Other IDs
- 2017-A03470-53
- Status last verified
- Feb 2019
- First submitted
- 4 Jun 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT03677349
- Acronym / sponsor ID
- CHU-392
- Keywords
- Oral cancer, Free Flap, Neurrorhaphy, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Hospital of Aurillac
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing).
Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.
Detailed description
Investigator will compare patients in whom the nervous suture will be performed and patients in whom it will not. If a significant difference in oral sensitivity is noted between these 2 groups, investigator can support our thesis: suturing the flap nerve increases its ability to regain sensitivity.
All patients are first diagnosed in consultation and presented at a carcinologic multidisciplinary consultation during which an individually adapted treatment is proposed (according to the French "Plan Cancer"). If it consists in a surgery with reconstruction using free flap technique at the same time, Investigator then propose to the patient to integrate our study. The possibility to participate to this study is therefore proposed to the patient on the same day that the plan of treatment is presented. The patient has a period of reflection, minimal time necessary to mature his reflection and make their choice with their loved ones and decide if they agree to participate to the study. His answer is required the day before the surgery. This represents a reflection period of two weeks on average. If he accepts it, computer software (RedCap®) will determine at random if the surgical team will perform a nervous suture or not. As a result, two groups patients are then created: one with nervous suture and one with no nervous suture. By comparing these two groups, investigator hope to demonstrate that there will be more patients with a flap sensitive in the "with nerve suture" group than in the "without nerve suture" group.
Investigator will then collect data from tests and questionnaires allowing us to judge the resensitization of the flap during follow-up consultations at 3, 6 months then at 1 year postoperatively in parallel follow-up consultations. That is to say that the patient therefore comes for a consultation as part of his cancer follow up and investigator take advantage of this time to carry out tests and questionnaires. This adds about 20 minutes of consultation time.
A preoperative evaluation will be done before the surgery corresponding to the basal state calibration. During these consultations, investigator perform two tests and investigator will provide 2 quality of life questionnaires to fill out:
- The two-discriminating points test: two points are applied on the flap at different distances and the patient must indicate if he feels one or two points.
- The hot/cold test: hot water and cold water are applied on the flap separately, and the patient should indicate if he feels the temperature differences.
- The QLQ-C30 and EOTRC H\&N 35 questionnaires: several questions concerning the quality of life are asked to the patient who must answer them as honestly as possible.
After collecting all this information, investigator can compare the sensitivity of free flaps with or without nerve suture.
In parallel, investigator will also evaluate the economic impact and cost that this can represent by comparing the operating and hospitalization times of patients in each group. Investigator believe that the operating time is not increased nor the length of hospitalization and therefore that there is no additional cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of primary and secondary outcomes measures between group 1 (resensitization by neurorrhaphy) and group 2 patients (No resensitization by neurorrhaphy). Patients randomly included in the groups according to a randomization software (RedCap)
| Arm | Type | Receives |
|---|---|---|
| Resensitized group | Experimental | Procedure: neurorrhaphyPatients with resensitized free flap by neurorrhaphy |
| Non Resensitized group | Experimental | Procedure: neurorrhaphyPatients without resensitized free flap by neurorrhaphy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Patient eligible for reconstructive surgery after carcinological excision following a decision taken in a multidisciplinary consultation, and for whom the envisaged oral defect concerns either the soft tissues of the oral cavity and oropharynx, or the mandibular bone
- Scheduled post-operative radiotherapy
- Coverage by the Social Security system
- Capacity to provide informed consent
Key exclusion criteria (7 listed)
- Post-traumatic substance loss (ballistic autolysis)
- Surgical or anesthetic contraindication (physiological age, other proposed therapeutic options)
- Pregnant or breastfeeding woman
- Subject incapable of full age or deprived of liberty
- Indication for chemotherapy with highly neurotoxic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurorrhaphyDuring the surgery, the flap is removed from its donor site, placed on the recipient site (instead of carcinological excision) and its survival is ensured by arterial and venous anastomosis (to the artery and facial vein or to the external carotid artery and thyro-linguofacial veinous trunk). We then propose a reconstruction complement: nerve anastomosis (neurorrhaphy) to the lingual nerve for the antebrachioradial and anterolateral thigh flaps, and to the lower alveolar nerve for the fibular bone flaps. This supplement is performed during microsurgical time by a suture for the patient in group 1. | Procedure or surgery | Non Resensitized group, Resensitized group |
Primary outcome
Epicritic sensitivity measurement
Time frame: Before intervention (at day 1).
It is a method of discriminating evaluation of epicritic sensitivity validated by the scientific literature
Thermoalgic sensitivity measurement
Time frame: Before intervention (at day 1)
Thermoalgic resensitization measured by Hot test
Thermoalgic sensitivity measurement
Time frame: Before intervention (at day 1)
Thermoalgic resensitization measured by cold test
6 secondary outcomes
Quality of life judged by QLQ-C30
Time frame: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
Quality of life judged by EOTRC H&N 35
Time frame: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
Voice Handicap Index
Time frame: Before intervention, 3 months post-surgery, 6 months post-surgery, 1 year post-surgery.
The Deglutition Handicap Index
Time frame: 6 months post-surgery
Economic evaluation
Time frame: 1 month post-hospitalization
impact on the cost of the stay
Time frame: 1 month post-hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud DEPEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurorrhaphy in people with Reconstructive Surgery After Carcinological Excision, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicritic sensitivity measurement (time frame: Before intervention (at day 1).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.