ACE.
Methods |
Study design: Multicentre RCT Method of randomisation: Stratified by centre Exclusions post randomisation: 7 (due to withdrawal from consent) Losses to follow up: 8 (EVAR = 3, OSR = 5) Intention‐to‐treat analysis: Yes |
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Participants |
Country: France Setting: Hospital (25 centres) Recruitment: 2003 to 2008 Number: 306 (149 OSR, 150 EVAR) Age: 69 ± 7 years (mean) Sex: 296 male / 3 female Inclusion criteria: Consisted of both anatomical criteria and clinical assessment. ‐ Anatomical criteria (based on CT scan findings):
‐ Clinical assessment:
Exclusion criteria:
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Interventions |
Treatment: EVAR Control: OSR |
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Outcomes |
Primary: All‐cause mortality, major adverse events (myocardial infarction, permanent stroke, permanent haemodialysis, major amputation, paraplegia and bowel infarction) Secondary: Vascular reinterventions and minor complications |
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Notes | Trial was conducted in individuals considered to be at low‐to‐medium risk of surgery Reinterventions for incisional hernia repair were not recorded In the EVAR group, 4 participants each had surgery under local and epidural anaesthesia. Remainder all had surgery under general anaesthesia |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation done based on centre |
Allocation concealment (selection bias) | Low risk | Allocation only notified < 24 hours |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and operating surgeons not feasible in such a study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No clear data available |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Presented results based on intention‐to‐treat and presented final follow up results. All participants accounted for |
Selective reporting (reporting bias) | Low risk | Reported on all predefined outcomes |
Other bias | Low risk | None identified |