Winter 2006.
| Methods | Randomized clinical trial
Allocation sequence: adequate, reported using a randomly generated number pattern.
Allocation concealment: adequate. We considered both allocation sequence generation and allocation concealment to be adequate.
Blinding: no mention Follow‐up: adequate, withdrawn: n = 4 Dropouts: n = 0 Intention‐to‐treat analysis: no, used per‐protocol analysis Sample size calculation: performed |
|
| Participants | Country: USA Single center: Johns Hopkins Medicine IRB, 238 participants were accrued between 8 March 2004 and 21 November 2005. No. randomized: 234 Age: 27 to 89 years Gender: Male/Female: 132/102 Inclusion criteria: Underwent a pylorus‐preserving PD Definition of pancreatic fistula: local definition and ISGPF Conflicts of interest: none |
|
| Interventions | In participants with a soft pancreas: 113 participants were randomly assigned to 1 of 2 groups: Stent (n = 57), No stent (n = 56) In participants with a hard pancreas: 121 participants were randomly assigned to 1 of 2 groups: Stent (n = 58), No stents (n = 63) |
|
| Outcomes | The main outcome measures were: Mortality Complications Reoperation Specific complications Postoperative length of stay |
|
| Notes | All participants underwent PD, but 4 participants were withdrawn from the study after enrollment and randomization. 234 participants who completed the study were analyzed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly generated number pattern |
| Allocation concealment (selection bias) | Unclear risk | Randomly generated number pattern |
| 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| Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information, and withdrawn: n = 4 |
| Selective reporting (reporting bias) | Low risk | According to the outcomes reported |
| Other bias | Unclear risk | Not mentioned |