A prospective randomized multicenter trial of distal pancreatectomy with and without routine intraperitoneal drainage
Annals of Surgery Aug 16, 2017
Van Buren G, et al. – This prospective randomized multicenter trial was undertaken to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Findings provide evidence that clinical outcomes were comparable in DP with or without intraperitoneal drainage.
Methods
- Researchers preoperatively randomized patients undergoing DP for all causes at 14 high-volume pancreas centers to placement of a drain or no drain.
- They assessed complications and their severity for 60 days and mortality for 90 days.
- The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications.
- They collected all data prospectively and reviewed source documents at the coordinating center to confirm completeness and accuracy.
Results
- DP was performed on 344 patients with (N = 174) and without (N = 170) the use of intraperitoneal drainage.
- The cohorts were similar regarding demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique.
- Findings revealed no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80).
- Similarity was observed regarding clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24).
- DP without routine intraperitoneal drainage seemed associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004).
- Researchers noticed no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores.
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