Bakker 2012.
| Methods | Randomised controlled trial | |
| Participants | Country: The Netherlands Number randomised: 22 Post‐randomisation exclusions: 0 (0%) Revised sample size: 22 Mean age: 63 years Females: 6 (27.3%) Mean duration of follow‐up: 12 months Inclusion criteria Adults needing necrosectomy for suspected or confirmed infected necrotising pancreatitis who could undergo both endoscopic or surgical necrosectomy, based on CT imaging Exclusion criteria Previous surgical or endoscopic necrosectomy Previous exploratory laparotomy Pancreatitis as a consequence of abdominal surgery A flare‐up of chronic pancreatitis Abdominal compartment syndrome Perforation of a visceral organ Bleeding as indication for intervention |
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| Interventions | Participants were randomly assigned to 1 of 2 groups Group 1: minimally invasive step‐up approach (video‐assisted) (n = 12) Group 2: minimally invasive step‐up approach (endoscopic) (n = 10) Open necrosectomy was performed if minimal access necrosectomy was unsuccessful |
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| Outcomes | Mortality, complications, hospital stay, number of necrosectomies | |
| Notes | Clinical endpoints were reported for 2 participants who were excluded from analysis of laboratory parameters and were included in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: this information was not available. |
| Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: this information was not available. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "An adjudication committee consisting of 5 gastrointestinal surgeons and 2 gastroenterologists independently reviewed all clinical end points and performed a blinded outcome assessment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants were included for clinical outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: all important outcomes were reported |
| Other bias | Low risk | Quote: "Dr Bakker is sponsored by grant number ZonMw 17099.2902 from the Netherlands Organization for Health Research and Development to perform clinical studies on necrotizing pancreatitis" Comment: no source of funding bias or any other bias |