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 |
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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% |
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Interventions |
Group A (n = 20): with anti‐syphon device (Vygon) Group B (n = 20): without anti‐syphon device (Chhabra and Ceredrain) |
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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 |
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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). |
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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. |