Buchler 1995.
Methods | Randomised controlled trial | |
Participants | Country: Germany Number randomised: 48 Post‐randomisation drop‐outs: 8 (16.7%) Revised sample size: 40 Mean age (years): 45 Women: 4 (10%) Follow‐up period (years): 14 Number of study centres: 1 Inclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 groups Group 1: duodenum‐preserving pancreatoduodenectomy (n = 20) (23 participants were randomised) Further details: Beger procedure Group 2: pancreatoduodenectomy (n = 20) (25 participants were randomised) Further details: Whipple procedure | |
Outcomes | Mortality, post‐operative complications, quality of life, length of hospital stay, proportion of people employed, diabetes, and exocrine insufficiency | |
Notes | Reasons for post‐randomisation drop‐outs: pancreatic cancer (n = 1), did not require pancreatic head resection (n = 7) | |
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 | Low risk | Comment: information on participant blinding was not available. It is impossible to blind surgeons who perform the procedure |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no participants were lost to follow‐up, although some participants were excluded from analysis (see other bias) |
Selective reporting (reporting bias) | Low risk | Comment: all important outcomes were reported |
Other bias | High risk | Comment: 1 participant had pancreatic cancer intra‐operatively and underwent Whipple procedure. The group to which this participant was randomised was not stated. 7 other participants were excluded from the analysis since they did not require pancreatic head resection. All the participants were symptomatic. Therefore, the reason for abandoning surgeries was not clear |