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

April 4, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3504

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 Contact Backup

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34000
        • Recruiting
        • CHU de Montpellier
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre-Olivier MOSER, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who did not have this exact procedure.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients operated
We studied all the patients who underwent an Amygdalo-Hippocampectomy in the University Hospital of Montpellier, France from 1995 until 2022
Procedure: Amygdalo-Hippocampectomy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications : Infections
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
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.
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
Post-operative complications : Hematomas
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.
Each post-operative complications have been studied during the medical follow-up. It included the immediate post-operative complications such as presence of hematoma.
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.
Post-operative way of life
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.
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.
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.
Risk factors or predisposing factors of success or failure after Amygdalo-Hippocampectomy
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
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.
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
Anti-Seizures Medications (ASM) evolution after the surgery
Time Frame: Medication prescribed before the surgery and medication prescribed at the last medical follow-up, assessed up to twenty years

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

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Gaetan POULEN, MD, PhD, CHU de MONTPELLIER, FRANCE

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)

August 31, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-08-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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