Complications After Epilepsy Surgery

NCT04727892 | Completed

• 1 other identifier: XJTU1AF2020LSK-167
• Study Type: observational
• Target: 2,026
• Locations: 0 countries
• Sites: N/A

Brief Summary

Epilepsy surgery is effective for refractory epilepsy, particularly focal epilepsy, but is still underutilized worldwide. In the United States, the annual percentage of surgical procedures for refractory epilepsy was low (range: 0.35%-0.63%) from 2003 to 2012. Fear associated with the risks of invasive procedures may be the reason for the cautious attitude towards epilepsy surgery. Therefore, the risks of epilepsy surgery in the modern age need to be evaluated thoroughly and precisely to improve epilepsy surgery outcomes. The safety of epilepsy surgery has been confirmed in several studies. Studies on this topic with large sample sizes (\> 500 patients) were either multicenter or covered a long study period. In addition, high-resolution magnetic resonance imaging (MRI) was not used in the early stage in these studies. Differences in medical environment among epilepsy centers and advancements in presurgical evaluations and surgical techniques over time may have caused heterogeneity and biases, thereby limiting the quality of these studies. Over the past two decades, there was no large-scale studies on post-epilepsy surgery complications performed at a single center. Moreover, surgery-related complications are seldom graded according to severity. Especially, the risk factors for these complications remain unclear.

Conditions

Epilepsy; Surgery--Complications

Keywords

epilepsy surgery; complication; prediction

Outcome Measures

Primary Outcomes (1)

• Complications

  Complications included neurologic deficit, cerebral edema, intracranial hemorrhage, infection, hydrocephalus, subdural effusion, subcutaneous cerebrospinal fluid accumulation, and poor wound healing. Neurologic deficit was classified as either transient (resolving within 3 months) or persistent (lasting more than 3 months) Complication severity was categorized into four grades based on the therapeutic regimen: grade I, minor complications, conservative treatment; grade II, major complications; grade III, life-threatening complications requiring invasive treatment under general anesthesia or monitoring in the intensive care unit; grade IV, death.

  in the 3-month period after epilepsy surgery

Secondary Outcomes (1)

• Predictors of complications.

  in the 3-month period after epilepsy surgery

Study Arms (1)

complications after epilepsy surgery

Group A with no complication; Group B with complications

Procedure: epilepsy surgery

Interventions

epilepsy surgery PROCEDURE

Surgical procedures were individually designed according to the presurgical evaluation findings. Standard epilepsy surgery procedures were applied. Generally, surgical procedures were divided into curative and palliative surgery. Curative surgery included resection and disconnection of the epileptogenic zone. Palliative surgery included corpus callosotomy for bilateral synchronous onset and multiple subpial transections for epileptic foci located in the eloquent cortex. For widespread epileptogenic zones, multiple surgical techniques were combined.

complications after epilepsy surgery

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

This is a large-scale retrospective study of patients undergoing epilepsy surgery performed by a single neurosurgeon, Dr. Zhang, at the single epilepsy centre from.

You may qualify if:

• (i) medically refractory epilepsy defined by the International League Against Epilepsyc; (ii) epilepsy surgery performed by a single neurosurgeon, Dr. H.Z.; (iii) surgical procedure performed via craniotomy.

You may not qualify if:

• Patients with neuromodulation therapy were excluded in this study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hua Zhang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: October 1, 2003
• Primary Completion: April 30, 2019
• Study Completion: May 1, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 0ct 2021, for 1 month
• Access Criteria: clinical study