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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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