No need for routine drainage after pancreatic head resection: the dual-center, randomized, controlled PANDRA trial (ISRCTN04937707)
Objective: - This dual-center, randomized, controlled, noninferiority trial aimed to prove that omission of drains does not increase reintervention rates after pancreatic surgery. - Background: - There is considerable uncertainty regarding intra-abdominal drainage after pan...
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| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 2016
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| In: |
Annals of surgery
Year: 2016, Volume: 264, Issue: 3, Pages: 528-537 |
| ISSN: | 1528-1140 |
| DOI: | 10.1097/SLA.0000000000001859 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1097/SLA.0000000000001859 Verlag, lizenzpflichtig, Volltext: https://journals.lww.com/annalsofsurgery/Fulltext/2016/09000/No_Need_for_Routine_Drainage_After_Pancreatic_Head.16.aspx 
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| Author Notes: | Helmut Witzigmann, Markus K. Diener, Stefan Kienkötter, Inga Rossion, Thomas Bruckner, Bärbel Werner, Olaf Pridöhl, Olga Radulova-Mauersberger, Heike Lauer, Phillip Knebel, Alexis Ulrich, Oliver Strobel, Thilo Hackert, and Markus W. Büchler |
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| 245 | 1 | 3 | |a No need for routine drainage after pancreatic head resection |b the dual-center, randomized, controlled PANDRA trial (ISRCTN04937707) |c Helmut Witzigmann, Markus K. Diener, Stefan Kienkötter, Inga Rossion, Thomas Bruckner, Bärbel Werner, Olaf Pridöhl, Olga Radulova-Mauersberger, Heike Lauer, Phillip Knebel, Alexis Ulrich, Oliver Strobel, Thilo Hackert, and Markus W. Büchler |
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| 520 | |a Objective: - This dual-center, randomized, controlled, noninferiority trial aimed to prove that omission of drains does not increase reintervention rates after pancreatic surgery. - Background: - There is considerable uncertainty regarding intra-abdominal drainage after pancreatoduodenectomy. - Methods: - Patients undergoing pancreatic head resection with pancreaticojejunal anastomosis were randomized to intra-abdominal drainage versus no drainage. Primary endpoint was overall reintervention rate (relaparotomy or radiologic intervention). Secondary endpoints were clinically relevant pancreatic fistula (grade B/C), mortality, morbidity, and hospital stay. The planned sample size was 188 patients per group. - Results: - A total of 438 patients were randomized. Forty-three patients (9.8%) were excluded because no pancreatic anastomosis was performed, and 395 patients (202 drain, 193 no-drain) were analyzed. Reintervention rates were not inferior in the no-drain group (drain 21.3%, no-drain 16.6%; P = 0.0004). Overall in-hospital mortality (3.0%) was the same in both groups (drain 3.0%, no-drain 3.1%; P = 0.936). Overall surgical morbidity (41.8%) was comparable (P = 0.741). Clinically relevant pancreatic fistula (grade B/C: drain 11.9%, no-drain 5.7%; P = 0.030) and fistula-associated complications (drain 26.4%; no drain 13.0%; P = 0.0008) were significantly reduced in the no-drain group. Operation time (P = 0.093), postoperative hemorrhage (P = 0.174), intra-abdominal abscess formation (P = 0.199), biliary leakage (P = 0.382), delayed gastric emptying (P = 0.062), burst abdomen (P = 0.480), wound infection (P = 0.758), and hospital stay (P = 0.487) did not show significant differences. - Conclusions: - Omission of drains was not inferior to intra-abdominal drainage in terms of postoperative reintervention and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. There is no need for routine prophylactic drainage after pancreatic resection with pancreaticojejunal anastomosis. | ||
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