Klempa 1995.
Methods | Randomised controlled trial | |
Participants | Country: Germany Number randomised: 43 Post‐randomisation drop‐outs: not stated Revised sample size: 43 Mean age (years): 47 years Women: 10 (23.3%) Follow‐up period (years): range 3‐5.5 years (mean not reported) Number of study centres: 1 Inclusion criteria
|
|
Interventions | Participants were randomly assigned to 1 of 2 groups Group 1: duodenum‐preserving pancreatoduodenectomy (n = 22) Further details: Beger procedure Group 2: pancreatoduodenectomy (n = 21) Further details: Whipple procedure | |
Outcomes | Mortality, post‐operative complications, length of hospital stay, proportion of people employed, diabetes, and exocrine insufficiency | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the patients according to the random number list (created prior to the study) were classified into two groups" |
Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available |
Blinding of participants and personnel (performance bias) All outcomes | Unclear 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 | Unclear risk | Comment: this information was not available |
Selective reporting (reporting bias) | Low risk | Comment: all important outcomes were reported |
Other bias | Unclear risk | Comment: it was not clear whether participants were excluded because of malignancy |
CT: computed tomography; DPPHR: duodenum‐preserving pancreatic head resection; n: number of participants; PPPD: pylorus‐preserving pancreaticoduodenectomy.