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

NCT06915649 | Recruiting

• 1 other identifier: 2024-08-115
• Study Type: observational
• Target: 3,504
• Locations: 1 country
• Sites: 1

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.

Conditions

Hippocampal Sclerosis; Dysembryoplastic Neuroepithelial Tumor; Cortical Dysplasia; Ganglioglioma; Cavernoma; Epidermal Cyst; Hamartoma; Pilocytic Astrocytoma; DGONC

Keywords

hippocampal sclerosis; hippocampectomy; amygdala-hippocampectomy; epilepsy surgery

Outcome Measures

Primary Outcomes (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

  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)

• Post-operative complications : Infections

  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

  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

  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

  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

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

Study Arms (1)

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

Interventions

Amygdalo-Hippocampectomy PROCEDURE

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.

Patients operated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who did not have this exact procedure.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, Hérault, 34000, France

RECRUITING

MeSH Terms

Conditions

Hippocampal Sclerosis; Malformations of Cortical Development; Ganglioglioma; Hemangioma, Capillary; Epidermal Cyst; Hamartoma; Astrocytoma

Condition Hierarchy (Ancestors)

Malformations of Cortical Development, Group I; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Hemangioma; Neoplasms, Vascular Tissue; Cysts

Study Officials

• Gaetan POULEN, MD, PhD

  CHU de MONTPELLIER, FRANCE

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: April 8, 2025
• Study Start: August 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

FR (1)