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Randomized Controlled Trial Multicenter Study Comparative Study
A Prospective Randomized Multicenter Trial of Distal Pancreatectomy With and Without Routine Intraperitoneal Drainage.
- George Van Buren, Mark Bloomston, Carl R Schmidt, Stephen W Behrman, Nicholas J Zyromski, Chad G Ball, Katherine A Morgan, Steven J Hughes, Paul J Karanicolas, John D Allendorf, Charles M Vollmer, Quan Ly, Kimberly M Brown, Vic Velanovich, Jordan M Winter, Amy L McElhany, Peter Muscarella, Christian Max Schmidt, Michael G House, Elijah Dixon, Mary E Dillhoff, Jose G Trevino, Julie Hallet, Natalie S G Coburn, Attila Nakeeb, Kevin E Behrns, Aaron R Sasson, Eugene P Ceppa, Sherif R Z Abdel-Misih, Taylor S Riall, Eric J Silberfein, Edwin C Ellison, David B Adams, Cary Hsu, Hop S Tran Cao, Somala Mohammed, Nicole Villafañe-Ferriol, Omar Barakat, Nader N Massarweh, Christy Chai, Jose E Mendez-Reyes, Andrew Fang, Eunji Jo, Qianxing Mo, and William E Fisher.
- *Michael E. DeBakey Department of Surgery, Baylor College of Medicine, The Elkins Pancreas Center, Houston, TX †Dan L. Duncan Cancer Center, Houston, TX ‡Department of Surgery, The Ohio State University, Columbus, OH §Department of Surgery, Baptist Memorial Hospital, University of Tennessee Health Science Center, Memphis, TN ¶Department of Surgery, Indiana University, Indianapolis, IN ||Department of Surgery, University of Calgary, Calgary, Alberta, Canada **Department of Surgery, Medical University of South Carolina, Charleston, SC ††Department of Surgery, University of Florida, Gainesville, FL ‡‡Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada §§Department of Surgery, Winthrop University Hospital, Mineola, NY ¶¶Department of Surgery, University of Pennsylvania, Philadelphia, PA ||||Department of Surgery, University of Nebraska Medical Center, Omaha, NE ***Department of Surgery, The University of Texas Medical Branch, Galveston, TX †††Department of Surgery, University of South Florida, Tampa, FL ‡‡‡Department of Surgery, Thomas Jefferson University, Philadelphia, PA.
- Ann. Surg. 2017 Sep 1; 266 (3): 421-431.
ObjectiveThe objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications.BackgroundThe use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported.MethodsPatients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked 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. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy.ResultsA total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores.ConclusionsThis prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.
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