Clinical trial NCT06915649: Exploration and Evaluation of Amygdalo-Hippocampectomy According to Prof. Coubes' Technique: An Anatomical, Clinical, and Educational Approach
Official title: Exploration and Evaluation of Amygdalo-Hippocampectomy According to Prof. Coubes' Technique: An Anatomical, Clinical, and Educational Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hippocampal Sclerosis
Dysembryoplastic Neuroepithelial Tumor
Cortical Dysplasia
Ganglioglioma
Cavernoma
Epidermal Cyst
Hamartoma
Pilocytic Astrocytoma
DGONC
Keywords: hippocampal sclerosis
hippocampectomy
amygdala-hippocampectomy
epilepsy surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 3504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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). 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-Surgical Classification assessing epilepsy's control
timeFrame: 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:
measure: Post-operative complications : Infections
timeFrame: 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
measure: Post-operative complications : Hematomas
timeFrame: 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.
measure: Post-operative way of life
timeFrame: 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.
measure: Risk factors or predisposing factors of success or failure after Amygdalo-Hippocampectomy
timeFrame: 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
measure: Anti-Seizures Medications (ASM) evolution after the surgery
timeFrame: Medication prescribed before the surgery and medication prescribed at the last medical follow-up, assessed up to twenty years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
state: Hérault
Study officials:
affiliation: CHU de MONTPELLIER, FRANCE
name: Gaetan POULEN, MD, PhD
role: STUDY_DIRECTOR
References: