Interventieonderzoek (trials en cohort)
Study reference Study characteristics Patient characteristics Intervention (I) Comparison / control (C) Follow-up Outcome measures and effect size Comments

Skirrow, 2011

Type of study:

Comparative retrospective study

 

Setting:

Great Ormond Street Hospital NHS Trust (GOSH)

 

Country:

UK

 

Source of funding:

NR

Inclusion criteria:

Preoperative

medication-resistant epilepsy, single pathologic diagnosis,

follow-up period ≥ 5 yrs, age ≥ 16 yrs at follow-up.

Patients as well as controls had preoperative investigations

for epilepsy surgery at GOSH between 1992 and 2002.

 

Exclusion criteria:

NR

 

N: 53

 

Intervention group:

N: 42

Mean age ± SD:13.3 (3.1)

Sex: 50% M (21)/ 50% F (21)

 

Control group:

N: 11

Mean age ± SD:NR

Sex: 36% M (4) / 64% F (7)

 

Groups comparable at baseline?

surgical and nonsurgical groups did not differ in terms of age at

seizure onset, age at follow-up, or preoperative FSIQ

Temporal lobe resection performed by neurosurgeon W.H.

No epilepsy surgery

Endpoint of follow-up:

Longitudinal change in IQ, psychosocial outcome including quality of life and preoperative and postoperative T1-weighted MRI brain scans (evaluated quantitatively).

 

Duration of follow-up:

Mean 9 yrs (range 5-15)

 

For how many participants were no complete outcome data available?

 

Intervention group:

N (%): 0/42

 

Control group:

N (%): 0/11

Seizure-free at follow-up:

I: 86%

C: 36%

P: 0.002

 

(After follow-up the intervention group showed, unlike the control group, a significant increase in IQ and a better psychosocial outcome including quality of life.)

- small study (n=53)

- control group differs in size and pathologic diagnosis

Tisi, 2011

Type of study:

Prospective cohort

 

Setting:

the National Hospital for Neurology and Neurosurgery

(NHNN)

 

Country:

UK

 

Source of funding:

UK Department of Health National Institute for Health Research (NIHR) Biomedical Research Centres

funding scheme, Epilepsy Society, Dr Marvin Weil Epilepsy Research Fund.

Inclusion criteria:

Patients who undergo epilepsy surgery in the National Hospital for Neurology and Neurosurgery

(NHNN), London, UK, from Feb 15, 1990, to Oct 30,

2008.

 

Exclusion criteria:

NR

 

N: 649

 

Mean age ± SD:

Range 16-63 yrs

 

Sex: 47% M (287)/ 53% F (328)

Epilepsy surgery:

Anterior temporal resections, temporal lesionectomies, extratemporal lesionectomies, extratemporal resections, hemispherectomies, palliative procedures (corpus callosotomy, subpial transaction).

No control

 

Endpoint of follow-up:

Seizure free (apart from simple partial seizures)

 

Duration of follow-up:

Median 8 yrs (range 1-19)

 

For how many participants were no complete outcome data available?

 

N (%): 34/649

 

Reasons for incomplete outcome data described?

Death (n=5), loss to follow-up (n=27), subsequent surgery within 1 yr of first operation (n=2)

 

Seizure free:

2 yr follow-up: 63% (95% CI 59-67)

5 yr follow-up: 52% (48-56)

10 yr follow-up: 47% (42-51)

 

Seizure free at 5 yr follow-up:

anterior temporal resection: 55% (51-60)

temporal lesionectomy: 56% (38-70)

extratemporal lesionectomy: 40% (24-55)

Hemispherectomy: 64% (30-85)

 

Surgical complications: death (n=19),  superior quadrant visual field defects (n=46), wound infections needing antibiotics (n=28), hemipareses (n=3), frontalis

muscle weakness (n=15), dysphasia (n=6), cerebrospinal fluid leaks needing resuturing (n=19) and deep venous thrombosis needing anticoagulation (n=1)

Van Oijen, 2006

Type of study:

Retrospective study

 

Setting:

University Medical Center Utrecht

 

Country:

The Netherlands

 

Source of funding:

NR

Inclusion criteria:

Resective surgery in the University Medical Center Utrecht between January first 1992 and January first 2002 because of unresponsiveness to anti-epileptic drugs.

 

Exclusion criteria:

NR

 

N: 69

 

Mean age ± SD:

9.2 (range 0.5-17)

 

Sex: 47.8% M (33) / 52.2% F (36)

Respective epilepsy surgery of which temporal resections (49%), extratemporal resections (24%) and hemispherectomies (27%)

 

No control

Endpoint of follow-up:

Seizure outcome by Engel classification (annually) and cognitive oucome

 

Duration of follow-up:

Mean 7.5 yrs (range 4-13)

 

For how many participants were no complete outcome data available?

 

N (%): 9/69

 

Reasons for incomplete outcome data described?

Death (n=4), loss to follow-up (n=5)

Seizure-free (=Engel 1)  at

First follow up (mean 4.5 yr range 1-10): 48/69 (68%)

Ssecond follow-up (mean 7.5 range 4-13): 50/69 (72%)

 

Seizure-free for temporal resection:

First follow-up: 25/34 (73%)

Second follow-up: 28/34 (82%)

 

Seizure-free for extratemporal resection:

First follow-up:6/10 (60%)

Second follow-up: 5/9 (56%)

 

Seizure-free for hemispherectomie:

First follow-up: 13/20 (65%)

Second follow-up: 12/19 (63%)

 

Surgical complications: died (n=1), postoperative aseptic meningitis (n=3) cerebral salt wasting (n=4), other temporal complications (n=5), development of different type of epilepsy (n=1), intraparenchymatous cysts (n=2)

 

-small study

- Incomplete data reporting

Wiebe, 2001

Type of study:

RCT

 

Setting:

Hospital based

 

Country:

UK

 

Source of funding:

Supported by a grant from Physicians’ Services Incorporated Foundation

Inclusion criteria:

≥16 yrs old, seizures with strong temporal-lobe semiology >1 yr, seizures occurred about monthly during the preceding year despite use of ≥2 drugs.

 

Exclusion criteria:

Brain lesions which required urgent surgery, progressive central nervous system disorders, active psychosis, pseudoseizures, IQ<70, previous surgery for epilepsy, evidence on EEG or MRI of extratemporal lesions or bilateral severe epileptogenic lesions.

 

N: 80

 

Intervention group:

N: 40

Mean age ± SD: 35.5±9.4

Sex: 42.5% M / 57.5% F

 

Control group:

N=40

Mean age ± SD: 34.4±9.9

Sex: 52.5% M / 47.5% F

 

Groups are comparable at baseline in age, employement status, level of education, duration of epilepsy, type and frequency of seizures, AED and MRI findings. Control group had lower QALY’s at base.

Surgery for temporal-lobe epilepsy

Treatment with antiepileptic drugs for one year

Endpoint of follow-up:

Primary outcome: freedom from seizures that impair awareness of self and surroundings

 

Secondary outcomes: frequency and severity of seizures, quality of life, disability and death

 

Duration of follow-up:

1 year

 

For how many participants were no complete outcome data available?

Intervention group: 1/40

Control group: 0/40

 

Reasons for incomplete outcome data described?

Death

 

Significant differences between groups?

No

Seizure free (complex partial or generalized seizures)

I: 58%

C: 8%

p<0.001

 

Seizure free all seizures (including  aura’s)

I: 38%

C: 3%

p<0.001

 

 

Reported adverse effects of surgery (n=4):

Small thalamic infarct, infected wound, decline in verbal memory

- small study population (n=80)

Hemb, 2013

Type of study: 
Prospective longitudinal cohort

Setting:
Epilepsy surgery centre in a university hospital

Country: 
Brazil

Source of funding:

Inclusion criteria: (1) a clinical history and video confirmation of a semiological pattern typical for MTLE, (2) interictal scalp-sphenoidal EEG with unilateral or independent bilateral anterior temporal epileptic discharges, (3) at least one electroclinical seizure recorded during video-EEG monitoring and (4) unilateral HS as indicated by MRI.

Exclusion criteria: Patients with atypical auras, early clonic or dystonic manifestations interictal discharges in the posterior temporal or extratemporal regions and a second lesion on MRI

N: 108

Mean age at onset: 8.2 yrs 

Sex: 52.7% M (N=57) /47.3% F (N=51)

Seizure type: Complex partial seizure: n=97 (89.8%)

Generalised tonic-clonic seizure: n=11 (10.2%)

Epilepsy surgery: Anterior temporal lobectomy or selective amygdalohippocampectomy

No control group

Endpoint of follow-up: Seizure control

Duration of follow-up: Minimum of 8 yrs – maximum 18 yrs (mean: 11 yrs, 9 months))

For how many participants were no complete outcome data available? 53 (33%):

Reasons for incomplete outcome data described? Could not be recontacted to assess current status, in spite of multiple efforts.

Seizure free at follow up 66/108 (61%)