Mohsen 2011.
| Methods | Single Centre RCT of thoracoscopic talc poudrage versus povidone‐iodine pleurodesis through an intercostal drain (Egypt) | |
| Participants | Inclusion: MPE as a complication of breast carcinoma Exclusion: performance status > 3; allergy to iodine; trapped lung; no change in MRC dyspnoea scale after thoracentesis; pleural fluid pH < 7.2; pleural fluid glucose < 60 mg/dl; extrathoracic metastasis 42 participants randomised |
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| Interventions | All participants underwent a VATS drainage and adhesiolysis Talc poudrage group: 4 g talc insufflation under thoracoscopic guidance at the end of the VATS procedure Iodine group: recovered from VATS. Then later that day, 20 ml 10% povidone‐iodine in 30 ml saline injected through the chest drain at the bedside. Drain clamped for four hours after instillation |
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| Outcomes | Efficacy of pleurodesis at two months (response defined as 'complete response' (CR) (absence of fluid re‐accumulation), 'partial response' (PR) (residual pleural fluid or re‐accumulation, which did not require further thoracocentesis or remained asymptomatic) or 'failure' (additional pleural procedures were necessary) Complications Length of hospital stay (in days) Survival Change in MRC dyspnoea score |
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| Notes | People with trapped lung excluded from trial entry CR + PR counted as pleurodesis success for analysis Included in network meta‐analysis for pleurodesis efficacy, mortality and fever |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomisation software used |
| Allocation concealment (selection bias) | Low risk | Computer randomisation software used |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not able to blind given the nature of the interventions |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom and side effect reporting would be effected by lack of blinding. Not stated if radiology was interpreted blindly. Mortality would not be biased by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Minimal missing data (primary outcome data available for all patients at two months) |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | No other biases identified |