Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial
العنوان: | Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial |
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المؤلفون: | Stéphanie Truant, François Mauvais, Guillaume Piessen, David Fuks, C. Cosse, Jean-Jacques Tuech, François-René Pruvot, J. Dembinski, J.-M. Regimbeau, Christophe Mariette, L. Schwarz |
المساهمون: | CHU Amiens-Picardie, Service de chirurgie digestive [CHU Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Service de chirurgie hepato-pancreato-biliaire, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Simplification des soins chez les patients complexes - UR UPJV 7518 (SSPC), Université de Picardie Jules Verne (UPJV) |
المصدر: | Journal of Visceral Surgery Journal of Visceral Surgery, Elsevier, 2019, 156, pp.103-112. ⟨10.1016/j.jviscsurg.2018.06.006⟩ |
بيانات النشر: | HAL CCSD, 2019. |
سنة النشر: | 2019 |
مصطلحات موضوعية: | Male, Reoperation, medicine.medical_specialty, Multivariate analysis, Time Factors, [SDV]Life Sciences [q-bio], law.invention, Pancreaticoduodenectomy, 03 medical and health sciences, Pancreatic Fistula, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, law, Risk Factors, Clinical endpoint, Medicine, Humans, Surgical Wound Infection, In patient, Postoperative Period, Drainage, Risk factor, Device Removal, Aged, Postoperative Care, business.industry, General Medicine, Length of Stay, Middle Aged, medicine.disease, 3. Good health, Surgery, Intention to Treat Analysis, Pancreatic fistula, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, business, Enhanced Recovery After Surgery, Postoperative fistula |
الوصف: | Summary Background To determine whether the timing of removal of abdominal drainage (AD) after pancreatoduodenectomy (PD) influences the 30-day surgical site infection (30-day SSI) rate. Methods A multicenter randomized, intention-to-treat trial with two parallel arms (superiority of early vs. standard AD removal on SSI) was performed between 2011 and 2015 in patients with no pancreatic fistula (PF) on POD3 after PD ( NCT01368094 ). The primary endpoint was the 30-day SSI rate. The secondary endpoints were specific post-PD complications (grade BC PF), postoperative morbidity and risk factor of SSI, reoperation rate, 30-day mortality, length of drainage, length of stay and postoperative infectious complications. Results One hundred and forty-one patients were randomized: 71 in the early arm, 70 in the standard arm (70.2% of pancreatic adenocarcinomas; 91.5% of pancreatojejunostomies; 66.0% of bilateral drainages; feasibility: 39.9%). Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P = 0.12). A lower rate of deep SSI was observed in the early arm (2.8% vs. 17.1%, P = 0.03), leading to a shorter length of stay (17.8 ± 6.8 vs. 21.0 ± 6.1, P = 0.01). Grade BC PF rate (5.6%), severe morbidity (17.7%), reoperation rate (7.8%), 30-day mortality (1.4%) and wound-SSI rate (7.8%) were similar between arms. After multivariate analysis, the timing of AD removal was not associated with an increase of 30-day SSI (OR = 0.74 [95% CI 0.35–1.13, P = 0.38]). Conclusion In selected patients with no PF on POD3, early removal of abdominal drainage does not seem to increase or decrease surgical site infection's occurrence. |
اللغة: | English |
تدمد: | 1878-7886 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f830906d27dfa2d1101436661c3a1cf8 https://hal.archives-ouvertes.fr/hal-03486531 |
حقوق: | OPEN |
رقم الأكسشن: | edsair.doi.dedup.....f830906d27dfa2d1101436661c3a1cf8 |
قاعدة البيانات: | OpenAIRE |
تدمد: | 18787886 |
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