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Hippocampal SclerosisNCT06915649

Exploration and Evaluation of Amygdalo-Hippocampectomy According to Prof. Coubes' Technique: An Anatomical, Clinical, and Educational Approach

An observational study of Hippocampal Sclerosis and Dysembryoplastic Neuroepithelial Tumor, run by University Hospital, Montpellier at 1 site in France.

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Sites and contacts
Official record
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Trial summary

The goal of this retrospective study is to evaluate the long-term clinical outcomes and complications associated with amygdalo-hippocampectomy using the surgical technique developed by Pr. Coubes (Montpellier, FRANCE). Read more about this study

Who is it for?
Any age
What is being tested?
Amygdalo-Hippocampectomy
Type of treatment
Surgery or procedure
How many people
3,504 participants
Where
1 siteFrance
Study dates
31 Aug 2024to Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All the patients that have been followed in the University Hospital of Montpellier, France in the Epileptic Ward.

Who may be able to join

  • Patients who had undergone an Amygdalo-Hippocampectomy according to the surgical procedure that we describe

Who cannot join

  • Patients who did not have this exact procedure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pierre-Olivier MOSER, Medical Doctor contact

+33 7 60 13 54 37

po-moser@chu-montpellier.fr

Gaetan POULEN, MD, PhD contact

+33 6 31 81 26 05

g-poulen@chu-montpellier.fr

France1 site, 1 recruiting
  • CHU de Montpellier

    Montpellier, Hérault, 34000

    Pierre-Olivier MOSER, MD, +33 7 60 13 54 37, po-moser@chu-montpellier.fr

    Gaetan POULEN, MD, PhD, +33 6 31 81 26 05, g-poulen@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

The goal of this retrospective study is to evaluate the long-term clinical outcomes and complications associated with amygdalo-hippocampectomy using the surgical technique developed by Pr. Coubes (Montpellier, FRANCE). The main questions it aims to answer are:

  • What are the complications and evolution of clinical outcomes in patients treated with this technique for hippocampal sclerosis or other intern temporal diseases ?
  • What variables are associated with better seizure control following surgery?

Participants include 234 patients treated over the last 30 years at the CHU de Montpellier, FRANCE. The study will analyze clinical data, including seizure outcomes based on ILAE criteria, post-operative complications, and factors influencing recovery and reintegration into daily life.

Read the detailed description

Title Exploration and Evaluation of Amygdalo-Hippocampectomy Using Pr. Coubes' Technique: An Anatomical, Clinical, and Pedagogical Approach

Introduction The hippocampus, a vital component of the limbic system, plays a key role in memory and emotions. Unfortunately, it is also prone to various pathologies, such as hippocampal sclerosis, a condition characterized by progressive neuronal degeneration and subsequent fibrosis of the medial temporal lobe. Other diseases may occur such as tumours, Dysembryoplastic Neuroepithelial Tumour (DNET) or gliomas.

This condition often leads to severe symptoms, including pharmacoresistant epilepsy and memory disturbances that significantly impair the quality of life.

For patients with pharmacoresistant epilepsy associated with hippocampal sclerosis, surgery has emerged as a first-line therapeutic option. Among the surgical techniques, hippocampectomy and amygdalo-hippocampectomy aim to remove the affected portion of the hippocampus, reducing seizure propagation and improving patient outcomes. However, these procedures are marked by significant variability in their operative techniques, extents of resection, and patient selection criteria.

While the amygdalo-hippocampectomy technique described by Pr. Yasargil in 1985 remains a cornerstone in surgical approaches, other methods such as the trans-sylvian approach (Adada et al., 2008), the trans-gyral approach (Mathon \& Clemenceau, 2016), and emerging endoscopic techniques (H. Westley Phillips, 2023) highlight the diversity and evolution of surgical options.

This study seeks to explore in detail the surgical technique developed by Pr. Coubes, analyzing its anatomical, surgical, and clinical aspects. Additionally, it aims to compare this method with other surgical approaches to understand its benefits and limitations better in managing hippocampal sclerosis.

Objectives Primary Objective

  • To describe the complications and the evolution of clinical outcomes in patients treated with Pr. Coubes' amygdalo-hippocampectomy technique.

Secondary Objective - To identify variables associated with favorable seizure control and overall clinical outcomes.

Study Design Type of Study

  • Retrospective, single-center study conducted at the CHU de Montpellier.

Population

  • 234 patients treated with this technique between 1980 and 2023, representing over three decades of clinical practice.
  • Inclusion of both adult and pediatric patients.

Data Collection

  • Retrospective extraction of clinical, imaging, and surgical data from patient records via the informatic patients' system.
  • Data categories include demographic details, pre- and post-operative imaging (MRI), seizure frequency and type (ILAE criteria), complications, return-to-work rates, and social reintegration metrics.

Methodology Statistical Analysis

  • Kaplan-Meier survival curves : Used to evaluate the time to the occurrence of complications or changes in clinical outcomes.
  • Cox proportional hazards models : Conducted in both univariate and multivariate settings to identify predictors of post-operative outcomes and complications.

Outcome Measures

  • Primary outcome : Seizure control evaluated using ILAE classification.
  • Secondary outcomes : Post-operative complications, return-to-work rates, and functional reintegration.

Ethical Considerations

  • Data Privacy : All patient data will be pseudonymized according to the French Ethic guidelines, with storage on secure CHU servers for a maximum of two years post-publication.
  • Patient Notification : Informational letters will be sent to patients, detailing the study's objectives and their rights to non-opposition.

Expected Contributions

  1. Clinical Insights : Comprehensive analysis of over 30 years of surgical practice, offering robust data on the efficacy and safety of Pr. Coubes' technique.
  2. Comparative Perspective : Enhanced understanding of how this technique compares to other established and emerging surgical approaches.
  3. Pedagogical Value : Detailed anatomical and surgical documentation to guide future training and clinical practice in neurosurgery.

Conclusion This study represents a unique opportunity to document and analyze a long-practiced yet unpublished surgical technique. By consolidating decades of clinical experience and integrating advanced analytical methods, it aims to provide valuable insights for improving the management of hippocampal sclerosis, ultimately advancing patient care and surgical education.

Being tested
Amygdalo-Hippocampectomy
Keywords
hippocampal sclerosis, hippocampectomy, amygdala-hippocampectomy, epilepsy surgery
Medical subject headings
Hippocampal Sclerosis, Malformations of Cortical Development, Ganglioglioma, Hemangioma, Capillary, Epidermal Cyst, Hamartoma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amygdalo-HippocampectomyProcedure or surgery

    This technique is characterized by specific hallmarks that distinguish it from other approaches, including the Yasargil technique and newer minimally invasive methods. It integrates precise anatomical targeting with optimized surgical pathways to enhance outcomes in patients with those pathologies. The approach of the choroidal fissure will be explained in the article.

    By addressing limitations observed in traditional techniques, it aims to minimize neurological deficits while achieving better seizure control.

Study groups in NCT06915649
Study groupRoleWhat they receive
Patients operatedWe studied all the patients who underwent an Amygdalo-Hippocampectomy in the University Hospital of Montpellier, France from 1995 until 2022
Receives: Procedure: Amygdalo-Hippocampectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-Surgical Classification assessing epilepsy's control

    The ILAE post-surgical classification system is used to categorize seizure outcomes after epilepsy surgery. It provides a standardized way to evaluate how effectively surgery controls seizures, enabling consistency in reporting and comparison of surgical outcomes across studies and clinical settings.

    In those cases of drug-resistance epilepsy, we will assess the epilepsy's control after the surgery.

    1. Completely seizure free; no auras
    2. Only auras; no other seizures
    3. One to three seizure days per year
    4. Four to 12 seizure days per year
    5. Daily seizures
    6. More than 100% increase of baseline ; auras

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.

Secondary outcomes (5)
  1. Post-operative complications : Infections

    Each post-operative complications have been studied during the medical follow-up. It included the immediate post-operative complications such as presence of an infection.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year

  2. Post-operative complications : Hematomas

    Each post-operative complications have been studied during the medical follow-up. It included the immediate post-operative complications such as presence of hematoma.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.

  3. Post-operative way of life

    As part of this research on the surgery, the investigators are studying the post-surgical way of life of patients who have undergone this procedure. This includes evaluating various aspects of their daily functioning, such as autonomy, cognitive and psychiatric outcomes, social integration, and overall quality of life. By analyzing these factors, the investigators aim to better understand the long-term impact of hippocampectomy and identify potential areas for improving patient care and rehabilitation strategies.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.

  4. Risk factors or predisposing factors of success or failure after Amygdalo-Hippocampectomy

    Among the patients who underwent favourable and unfavourable evolutions, we will assess the risk factors and the predisposing factors such as febrile seizure, medical history, etiologic lesions.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years

  5. Anti-Seizures Medications (ASM) evolution after the surgery

    The investigators have also compared the potential evolution of the medications after the surgery given the drug-resistance profil of these patients.

    The number of tablets have been reported before the surgery and at the last medical follow-up.

    Measured: Medication prescribed before the surgery and medication prescribed at the last medical follow-up, assessed up to twenty years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start31 Aug 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,504 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915649
Sponsor's protocol ID
2024-08-115
Status last verified
Apr 2025
First submitted
16 Jan 2025
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hippocampal Sclerosis and Dysembryoplastic Neuroepithelial Tumor, run by University Hospital, Montpellier 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pierre-Olivier MOSER, Medical Doctor (+33 7 60 13 54 37, po-moser@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Surgical Classification assessing epilepsy's control (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to twenty years. The study starts in 2024 and ends in 2025, which lasts one year.). 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 8 Apr 2025.

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