Complications After Epilepsy Surgery

January 26, 2021 updated by: Zhang Hua, First Affiliated Hospital Xi'an Jiaotong University

Severity Grading, Risk Factors and Prediction Model of Complications After Epilepsy Surgery: a Single-center, Large-scale and Retrospective Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Epilepsy, involving a persistent predisposition to seizure, is one of the most common chronic neurological disorders, affecting more than 65million people worldwide. Epilepsy not only negatively impacts patients'education, employment, and social contact, but also imposes a serious burden on patients'families and on society. Notably, epilepsy is the second most burdensome neurological disorder, accounting for 0.7% of disability-adjusted life years worldwide, according to the World Health Organization's 2010 Global Burden of Disease study, making it a global public health issue.

Furthermore, about 40% of patients respond poorly to the first 2 antiepileptic drugs and have medically refractory epilepsy. 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. Moreover, the number of surgical procedures for mesial temporal sclerosis (the most common type of refractory epilepsy) declined by more than half from 2006 to 2010. 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. From 1980 to 2012, neurological deficits following epilepsy surgery decreased with time, from 41.8% to 5.2% in temporal resections and from 30.2% to 19.5% in extratemporal resections. However, 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.

Understanding the incidence and severity of complications after epilepsy surgery and the associated risk factors is beneficial, allowing physicians to provide patients with adequate surgical advice, and allowing patients to make rational decisions regarding epilepsy surgery. Furthermore, this information may help in the prevention of postoperative complications and improve our understanding of the procedures. Therefore, we reported the incidence of complications occurring in a three-month period after epilepsy surgery performed by the single neurosurgeon at the single center, identified the associated risk factors, and developed a nomogram for individually predicting the probability of complications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2026

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • Patients with neuromodulation therapy were excluded in this study.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
complications after epilepsy surgery
Group A with no complication; Group B with complications
Procedure: epilepsy surgery
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: in the 3-month period after epilepsy surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictors of complications.
Time Frame: in the 3-month period after epilepsy surgery

Potential factors included the preoperative, intra-operative, and postoperative clinical characteristics, such as sex, age at surgery, duration of seizure, previous medical history, pathology, serial number of surgery, invasive electrode implantation, type of surgical procedure, surgery duration, intra-operative blood loss, and acute postoperative seizure.

Risk factors for complications were determined by using univariate and multivariate logistic regression analyses. Variables with P< .10 were selected as a potential risk factors and included in the multivariate logistic regression analysis. The forward stepwise method was used to select the variables that were eventually included in the model. Odds ratio (OR) and 95% confidence interval (CI) were calculated.
in the 3-month period after epilepsy surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hua Zhang, PhD, First Affiliated Hospital Xi'an Jiaotong University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2020LSK-167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Partial participant data are to be shared with other researchers

IPD Sharing Time Frame

0ct 2021, for 1 month

IPD Sharing Access Criteria

clinical study

IPD Sharing Supporting Information Type

  • SAP
  • CSR

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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