Tani 2010.
| Methods | A prospective randomized clinical trial (registered at www.clinicaltrials.gov, ID# NCT00628186) Allocation sequence: adequate Allocation concealment: adequate, used CONSORT flow diagram. We considered both allocation sequence generation and allocation concealment to be adequate. Blinding: no mention Follow‐up: adequate Dropouts: n = 0 Informed consent: reported Intention‐to‐treat analysis: used Sample size calculation: performed |
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| Participants | Country: Japan Single center: Wakayama Medical University Hospital, between April 2005 and August 2007. No. randomized: 100 Age: 35 to 87 years Gender: Male/Female: 55/45 Inclusion criteria: Underwent PD for pancreatic head and periampullary disease. Exclusion criteria: Severe associated diseases that might prolong hospital stay. Condition inadequately diagnosed for this trial by a physician. Could not have a pancreatic stent placed Definition of pancreatic fistula: ISGPF Conflicts of interest: none |
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| Interventions | 100 participants who underwent PD were randomly assigned to 1 of 2 groups: Group 1: External drainage (n = 50) Group 2: Internal drainage (n = 50) | |
| Outcomes | The main outcome measures were: Postoperative hospital stay Mortality and morbidity Pancreatic fistula Delayed gastric emptying Intra‐abdominal hemorrhage Intra‐abdominal abscess |
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| Notes | One participant in group 1 died in the hospital | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used CONSORT flow diagram |
| Allocation concealment (selection bias) | Low risk | Used CONSORT flow diagram |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information |
| Selective reporting (reporting bias) | Low risk | According to the outcomes reported |
| Other bias | Unclear risk | Not mentioned |