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. 2020 Jun 16;2020(6):CD012726. doi: 10.1002/14651858.CD012726.pub2

Khan 2010.

Study characteristics
Methods Study design: parallel‐group randomised trial
Study dates: study dates not available
Setting: inpatient procedure ‐ outpatient follow‐up
Country: India
Participants Inclusion criteria: participants between 20 days to 8 months, with progressive hydrocephalus with or without neural tube defect (NTD). The most common cause of hydrocephalus in children without NTD was aqueductal stenosis.
Exclusion criteria: patients having meningitis, ventriculitis, hydrocephalus secondary to mass lesions, intraventricular haemorrhage, peritoneal infection or peritoneal adhesions
Sample size: 40 eligible were randomly allocated using random number table. Patients: 26 NTD hydrocephalus and 14 without NTD
Age (years):
Group A: Anti‐siphon group (20 days to 8 months, mean 3.5)
Group B: Non‐antisyphon (25 days to 8 months)
Sex (M/F) Group A: 6 female, 14 male; Group B: 5 female, 15 male
Relevant participant details:
Group A:
Neural tube defect 35%
Low shunt pressure 85%
Medium shunt pressure 15%
Group B:
Neural tube defect 35%
Slow shunt pressure 80%
Medium shunt pressure 20%
Interventions Group A (n = 20): with anti‐syphon device (Vygon)
Group B (n = 20): without anti‐syphon device (Chhabra and Ceredrain)
Outcomes Treatment failure
How measured: number of participants with shunt block, shunt infection and over‐drainage
Time points measured: 3 and 6 months
Time points reported: unclear (possibly 6 months)
Adverse events (morbidity)
How measured: number of participants with shunt block, shunt infection and over‐drainage
Time points measured: 3 and 6 months
Time points reported: unclear (possibly 6 months)
Head circumference
How measured: Occipito frontal circumference (OFC)
Time points measured: at discharge, 3 and 6 months postoperative
Time points reported: at discharge, 3 and 6 months postoperative
Ventricular size
How measured: Modified Evan’s index (MEI) assessed by computerised tomography
Time points measured: at discharge, 3 and 6 months postoperative
Time points reported: at discharge, 3 and 6 months postoperative
Mortality for all causes: not reported
Quality of life: not reported
Funding sources Not available
Declarations of interest Not available
Notes No description was made about why surgeons chose different pressures and little information is provided on the types of valves used.
Contact information: drrizwanahmadkhan@yahoo.co.in (R.A. Khan).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were randomly allocated to the two groups of the shunts using random number table."
Allocation concealment (selection bias) Unclear risk No information available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias)
Subjective outcomes: treatment failure, adverse events, quality of life High risk No information about blinding available, however blinding was unlikely due to the visibly different interventions.
Blinding of participants and personnel (performance bias)
Objective outcomes: mortality, head circumference, ventricular size Low risk No information about blinding available. Outcomes were likely to be unaffected by blinding.
Blinding of outcome assessment (detection bias)
Subjective outcomes: treatment failure, adverse events, quality of life High risk No information about blinding available, however blinding was unlikely due to the visibly different interventions.
Blinding of outcome assessment (detection bias)
Objective outcomes: mortality, head circumference, ventricular size Low risk No information about blinding available. Outcomes were likely to be unaffected by blinding.
Incomplete outcome data (attrition bias)
All outcomes Low risk All outcomes: outcome data were available for all participants.
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ (no protocol available)
Other bias Low risk No other sources of bias were identified.