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Design Details
Arms
Arm Details
Sample Characteristics
Outcomes
Outcome Details
Risk of Bias Assessment
Results
Print Data

Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design


	RCT Nonrandomized comparative study Pre/post observational study

2. Country


	Japan

3. Total sample size


	75

4. Intervention Type


	Pharmacological Dietary Surgery

5. Funding source

Arms

Arm Name	Arm Description
Hemispherotomies	22 vertical parasagittal hemispherotomy, 5 periinsular hemispherotomy
Multilobar surgeries, unilobar surgeries	1 subtotal hemispherotomy, 13 posterior quadrantic disconnection, 5 multilobar cortical resections. 8 anterior temporal lobectomies, 5 frontal lobectomies or disconnections, 16 focal cortical resection or lesionectomies.

Arm Details

1. Sample size for arm

Hemispherotomies


	27

Multilobar surgeries, unilobar surgeries


	19 multilobar surgeries, 29 unilobar surgeries

2. Inclusion Criteria

Hemispherotomies


	For inclusion, patients were required to have ≥ 1 year follow up post operative, and post-operative developmental assessment at 1 year or the last follow up after 2 years or longer.

Multilobar surgeries, unilobar surgeries


	For inclusion, patients were required to have ≥ 1 year follow up post operative, and post-operative developmental assessment at 1 year or the last follow up after 2 years or longer.

3. Exclusion Criteria

Hemispherotomies


	Excluded patients who had undergoing palliative procedures (corpus callosomty and vagus nerve stimulation implantation).

Multilobar surgeries, unilobar surgeries


	Excluded patients who had undergoing palliative procedures (corpus callosomty and vagus nerve stimulation implantation).

4. Treatment details

Hemispherotomies


	22 vertical parasagittal hemispherotomy, 5 periinsular hemispherotomy

Multilobar surgeries, unilobar surgeries


	1 subtotal hemispherotomy, 13 posterior quadrantic disconnection, 5 multilobar cortical resections. 8 anterior temporal lobectomies, 5 frontal lobectomies or disconnections, 16 focal cortical resection or lesionectomies.

Sample Characteristics

1. Gender, number of male

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	36

2. Gender, percentage of male

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	48

3. Age at intervention (mean)

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	11.9 months

4. Age at intervention (SD)

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	± 10.8 months

5. Age at intervention (range)

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	58 days - 35 months

6. Age at intervention (median)

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	6 months

7. Seizure types and/or etiology

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	Etiology was hemimegalencephaly (HME) 22, other malformations of cortical development 33, low-grade developmental tumors 10, tuberous sclerosis complex 6, Surge-Weber syndrome 3, perinatal ischemia 1. Type of seizures NR

8. Prior treatment

Hemispherotomies


	NR

Multilobar surgeries, unilobar surgeries


	NR

Total


	ASMs at surgery mean 2.21 (range 1-6)

9. Comments

Hemispherotomies

Multilobar surgeries, unilobar surgeries

Total

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Adverse Event	Mortality	All participants	Baseline
Categorical	Adverse Event	Hydrocephalus requiring surgical intervention	All participants	Baseline
Categorical	Adverse Event	Cyst formation requiring surgical intervention	All participants	Baseline
Categorical	Adverse Event	Cerebral salt wasting syndrome	All participants	Baseline
Categorical	Adverse Event	Diabetes insipidus	All participants	Baseline
Categorical	Adverse Event	Sinus thrombosis (attributed to diabetes insipidus by study authors)	All participants	Baseline
Categorical	Adverse Event	Asymptomatic hemorrhagic infarction	All participants	Baseline
Categorical	Adverse Event	Infection (bacterial meningitis)	All participants	Baseline
Categorical	Adverse Event	Psychiatric symptom	All participants	Baseline
Categorical	Adverse Event	Asymptomatic cerebral infarction (requiring medical treatment)	All Participants	Baseline

Outcome Details

1. For RCTs: Generation of randomization sequence

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

2. For RCTs: Allocation concealment

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

3. For RCTs: Baseline imbalance

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

4. For RCTs: Patient blinded

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

5. For RCTs: Staff blinded

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

6. For RCTs: Differential ancillary treatments

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

7. For RCTs: Adherence

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

8. For RCTs: Analytic approach to address departures from intended intervention

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

9. For RCTs: Data on at least 80% of those enrolled

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

10. For RCTs: Differential dropout <=15%

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

11. For RCTs: Standard way to measure the outcome

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

12. For RCTs: Blinded outcome assessor

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

13. For RCTs: Bias in selection of reported results

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

14. For nonrandomized comparative studies: Confounding

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

15. For nonrandomized comparative studies: Selection into study

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

16. For nonrandomized comparative studies: Classification of interventions

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

17. For nonrandomized comparative studies: Differential ancillary treatments

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

18. For nonrandomized comparative studies: Adherence

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

19. For nonrandomized comparative studies: Data on at least 80% of those enrolled

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

20. For nonrandomized comparative studies: Differential dropout <=15%

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

21. For nonrandomized comparative studies: Standard way to measure the outcome

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

22. For nonrandomized comparative studies: Blinded outcome assessor

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

23. For nonrandomized comparative studies: Bias in selection of reported result

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

24. For single arm studies: Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

26. For single arm studies: Did the study maintain fidelity to the intervention protocol?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

27. For single arm studies: If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Risk of Bias Assessment

1. For Risk of Bias Assessment results, see Outcome Details section.

Results

Categorical

Adverse Event (Mortality)

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Hydrocephalus requiring surgical intervention )

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Cyst formation requiring surgical intervention)

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Cerebral salt wasting syndrome )

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Diabetes insipidus)

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Sinus thrombosis (attributed to diabetes insipidus by study authors))

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Asymptomatic hemorrhagic infarction)

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Infection (bacterial meningitis))

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Psychiatric symptom)

All participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries

Adverse Event (Asymptomatic cerebral infarction (requiring medical treatment))

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Hemispherotomies	Multilobar surgeries, unilobar surgeries