CHU de Montpellier
Montpellier, Hérault, 34000, France
Location status: Recruiting
Location contact
Gaetan POULEN, MD, PhD
CONTACT
Pierre-Olivier MOSER, MD
CONTACT
Pierre-Olivier MOSER, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06915649
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.
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Observational
Montpellier, Hérault, 34000, France
Location status: Recruiting
Gaetan POULEN, MD, PhD
CONTACT
Pierre-Olivier MOSER, MD
CONTACT
Pierre-Olivier MOSER, MD
PRINCIPAL_INVESTIGATOR
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
Secondary Objective - To identify variables associated with favorable seizure control and overall clinical outcomes.
Study Design Type of Study
Population
Data Collection
Methodology Statistical Analysis
Outcome Measures
Ethical Considerations
Expected Contributions
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Gaetan POULEN, MD, PhD
CONTACT
Pierre-Olivier MOSER, Medical Doctor
CONTACT
University Hospital, Montpellier
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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