Duffas 2005.
| Methods | Randomized controlled trial Multicenter |
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| Participants | Country: France.
Number randomized: 149. Post‐randomization dropout: 0 (0%). Mean age: 58.4 years. Female: 63 (42.3%). Pancreatic cancer: 59 (39.6%). Biliary cancer: 19 (12.8%). Ampullary cancer: 36 (24.1%). Duodenal cancer: 6 (4.0%). Other: 29 (19.5%). Classic pancreaticoduodenectomy: 113 (75.8%). Pylorus‐preserving pancreaticoduodenectomy: 36 (24.2%). Inclusion criteria:
Exclusion criteria:
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| Interventions | Participants (N = 149) were randomly assigned to two groups. Group 1: Pancreaticojejunostomy (N = 68). Group 2: Pancreaticogastrostomy (N = 81). | |
| Outcomes | Postoperative pancreatic fistula: Yes. Postoperative mortality: Yes. Length of hospital stay: Yes. Rate of surgical re‐intervention: Yes. Overall rate of surgical complications: Yes. Rate of postoperative bleeding: Yes. Rate of intra‐abdominal abscess: Yes. Quality of life: No. Cost analysis: No. |
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| Notes | Definition of pancreatic fistula: (1) chemically as fluid obtained through drains or percutaneous aspiration, containing at least 4 times normal serum values of amylase for 3 days, irrespective of the amount of output and the date of appearance or (2) clinically and radiologically, as anastomotic leaks shown by fistulography. The calculated sample size, based on the reduction of intra‐abdominal complications rate from 40% to 20%, was 134 participants and the study met its estimated accrual. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computerized random number tables". |
| Allocation concealment (selection bias) | Low risk | Quote: "Random allotment was through a telephone call to the coordinating center". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Postoperative complications were assessed by a physician who was unaware of the allotted treatment". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "There were no protocol violations, no crossovers, or withdrawals after randomization". Comment: There were no post‐randomization dropouts. |
| Selective reporting (reporting bias) | Low risk | Comment: All the primary outcomes were reported. The review authors consider this study to be free of selective reporting for the primary outcomes. |
| Other bias | Low risk | Comment: The study appears to be free of other sources of bias. |