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Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma.
Ahmad, SA, Duong, M, Sohal, DPS, Gandhi, NS, Beg, MS, Wang-Gillam, A, Wade, JL, Chiorean, EG, Guthrie, KA, Lowy, AM, et al
Annals of surgery. 2020;(3):481-486
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Abstract
OBJECTIVE The optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear. METHODS S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity. RESULTS Between 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA. CONCLUSIONS We have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging.
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Perioperative management of vitamin K antagonists in patients with low thromboembolic risk undergoing elective surgery: A prospective experience.
Becerra, AF, Cornavaca, MT, Revigliono, JI, Contreras, A, Albertini, R, Tabares, AH
Medicina clinica. 2017;(7):281-286
Abstract
BACKGROUND AND OBJECTIVES To quantify thromboembolic and bleeding events in patients with low thromboembolic risk, who were chronically receiving vitamin K antagonists and undergoing elective surgery. MATERIAL AND METHODS A descriptive, prospective, single-center study was conducted between December 2010 and July 2014. Patients aged over 18 years old, chronically anticoagulated with vitamin K antagonists and admitted for elective surgery were included in the study. We excluded patients with a creatinine clearance<30ml/min, a body weight>120kg, heparin-induced thrombocytopenia, pregnant women, carriers of an epidural catheter for analgesia, patients who underwent unscheduled surgery and high thromboembolic risk-patients. Vitamin K antagonists were discontinued 5 days prior to the procedure without administering anticoagulant enoxaparin. The NIR was measured 24h before the procedure. A single dose of 3mg of vitamin K was administered in cases of a NIR>1.5. Vitamin K antagonists was resumed according to the surgical bleeding risk. Events were registered between 5 days prior to the procedure until 30 days after it. RESULTS A total of 75 procedures were included in the study. Fifty-six patients (74.7%) received vitamin K antagonists for atrial fibrillation, 15 suffered from venous thromboembolism (20%) and 4 had mechanical heart valves (5.3%). Twenty-six patients (34.5%) underwent high-bleeding risk surgeries and 49 (65.5%) underwent low risk procedures. No thromboembolic event was recorded. Four bleeding events (5.3%) were reported, 3 of which were considered major bleeding events (2 fatal). CONCLUSIONS Suspending vitamin K antagonists with no bridging therapy performed in patients with a low thromboembolic risk does not expose such patients to a significant risk of embolic events.
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Periprocedural nutrition in the intensive care unit: a pilot study.
Yeh, DD, Cropano, C, Quraishi, SA, Fuentes, E, Kaafarani, H, Lee, J, Velmahos, G
The Journal of surgical research. 2015;(2):346-50
Abstract
BACKGROUND Enteral nutrition (EN) delivery in the surgical intensive care unit (ICU) is often suboptimal as it is commonly interrupted for procedures. We hypothesized that continuing perioperative nutrition or providing compensatory nutrition would improve caloric delivery without increasing morbidity. MATERIALS AND METHODS We enrolled 10 adult surgical ICU patients receiving EN who were scheduled for elective bedside percutaneous tracheostomy. In these patients (fed group), either perioperative EN was maintained or compensatory nutrition was provided. We compared the amount of calories delivered, caloric deficits, and the rate of complications of these patients with those of 22 contemporary controls undergoing tracheostomy while adhering to the traditional American Society of Anesthesiology nil per os guidelines (unfed group). We defined caloric deficit as the difference between prescribed calories and actual delivered calories. RESULTS There was no difference in demographic characteristics between the two groups. On the day of procedure, the fed group had higher median delivered calories (1706 kcal; interquartile range [IQR], 1481-2009 versus 588 kcal; IQR, 353-943; P < 0.0001) and received a higher percentage of prescribed calories (92%; IQR, 82%-97% versus 34%; IQR, 24%-51%; P < 0.0001). Median caloric deficit on the day of the procedure was significantly lower in the fed group (175 kcal; IQR, 49-340 versus 1133 kcal; IQR, 660-1365; P < 0.0001). There were no differences in total overall ICU complications per patient, gastrointestinal complications on the day of procedure, or total infectious complications per patient between the two groups. CONCLUSIONS In our pilot study, perioperative and compensatory nutrition resulted in higher caloric delivery and was not associated with increased morbidity.
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Prophylactic Nasogastric Decompression for Routine Gastrectomy.
Pang, MH, Xu, J, Wu, YF, Luo, B
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP. 2015;(7):491-4
Abstract
OBJECTIVE To determine the necessity of using nasogastric tubes for patients with gastrectomy. STUDY DESIGN A non-randomized controlled trial with two arms. PLACE AND DURATION OF STUDY Sichuan Provincial Peoples' Hospital, China, from February 2012 to January 2014. METHODOLOGY One hundred and twenty one patients undergoing gastrectomy were assigned into intubation group and control group based on patient's own will. The intubation group was intubated with a nasogastric tube before operation and extubated at the earliest evidence of passed flatus. Clinical outcomes, such as operation time, bleeding volume, time to passage of flatus, postoperative complications, and length of stay were recorded and compared between the two groups along with patient characteristics. RESULTS The two groups did not differ in patient characteristics with similar distribution of gender, age, diagnosis, tumor location and operation type. Nasogastric intubation before surgery was not associated with statistically significant difference in total surgery duration, bleeding volume of operation or postoperative complications. In addition, patients without nasogastric tubes resumed oral diet earlier (52.5 ± 14.1 vs.18.4 ± 2.0 hours, p < 0.05) and had shorter time to first passage of flatus (43.8 ± 11.2 vs. 49.0 ± 13.3 hours, p=0.02). CONCLUSION It is safe to give up nasogastric intubation for patients undergoing elective gastrectomy and may even result in a better patient outcome.
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Reduced infections with perioperative immunonutrition in head and neck cancer: exploratory results of a multicenter, prospective, randomized, double-blind study.
Falewee, MN, Schilf, A, Boufflers, E, Cartier, C, Bachmann, P, Pressoir, M, Banal, A, Michel, C, Ettaiche, M
Clinical nutrition (Edinburgh, Scotland). 2014;(5):776-84
Abstract
BACKGROUND & AIMS Head and neck cancer surgery is affected by complications in 20-60% of cases, with risk factors being malnutrition, alcoholism and immunosuppression due to cancer. The aim of the study was to investigate whether preoperative or perioperative immunonutrition could reduce postoperative infectious complications (IC) and surgical-site infections (SSI) in this population. METHODS This was a multicenter, prospective, randomized, double-blind study. Patients with oropharyngeal and pharyngolaryngeal tumour were randomly allocated to three groups: a) perioperative formula of Impact(®) without immune nutrients, named "reference diet" (group A, control); b) preoperative Impact(®) and "reference diet" postoperatively (group B); c) Impact(®) perioperatively (group C). Products were available in oral and enteral formula and were given 7 days before surgery and for 7-15 days postoperatively. The primary and secondary endpoints were the incidence of IC and SSI, respectively. RESULTS Of 312 randomized patients, 205 were evaluable for ITT analysis. There was no significant difference in IC and SSI. However out of this population, only 64 patients had taken at least 75% of the theoretical intake from surgery to day 10 (per-protocol population). In this condition, a significant difference in IC (OR = 0.24, p = 0.05), SSI (OR = 0.17, p = 0.04) and also in the median length of postoperative stay (18 vs. 25 days, p = 0.05) was demonstrated between groups A and C. CONCLUSIONS In the ITT population, no significant difference in IC, SSI and LOS was demonstrated. Positive exploratory results on the perioperative Impact(®) per-protocol population, encourage further study in head and neck cancer patients. Registered under ClinicalTrials.gov Identifier no. NCT00765440.
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Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis.
Spinelli, A, Bazzi, P, Sacchi, M, Danese, S, Fiorino, G, Malesci, A, Gentilini, L, Poggioli, G, Montorsi, M
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract. 2013;(1):126-32; discussion p.132
Abstract
BACKGROUND Laparoscopy combined with an enhanced recovery pathway (ERP) is widely considered to be the first-choice option for patients with colorectal cancer. However, no previous reports have focused on patients with Crohn's disease (CD) treated by laparoscopy and ERP. METHODS Twenty patients with CD underwent laparoscopic ileocecal resection with an ERP at two institutions. The ERP protocol included no bowel preparation nor fasting, no nasogastric tube, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization, opioid-sparing analgesia and restrictive fluid management. This group was compared with a matched historical control group of 70 CD patients who underwent laparoscopic ileocecal resection treated with conventional care. RESULTS Compliance with the ERP was high (≥80 %) for all items except no drain placement. A significantly earlier return of bowel function (time to first flatus and stool) was observed in the ERP group. Mean postoperative and total length of stay were significantly shorter in the ERP group. Postoperative complications were similar in both groups. CONCLUSIONS This is the first reported experience of laparoscopy with ERP in CD patients and suggests that optimized perioperative care combined with minimally invasive techniques may lead to further improvements in surgical outcomes for CD patients.
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Initial experiences of an enhanced recovery protocol in esophageal surgery.
Blom, RL, van Heijl, M, Bemelman, WA, Hollmann, MW, Klinkenbijl, JH, Busch, OR, van Berge Henegouwen, MI
World journal of surgery. 2013;(10):2372-8
Abstract
BACKGROUND A recent development in gastrointestinal surgery is the implementation of enhanced recovery after surgery (ERAS) programs. Evidence regarding the benefit of these programs in patients undergoing esophageal surgery is scarce. We investigated the feasibility and possible benefit of a perioperative ERAS program in patients undergoing esophagectomy for malignant disease. METHODS The ERAS program was initiated in 2009. Patients who underwent esophagectomy and were treated according to the ERAS program were included. Items of ERAS included preoperative nutrition, early extubation, early removal of nasogastric tube, and early mobilization. Primary outcome parameters were hospital stay and the incidence of postoperative complications. Outcome parameters in the ERAS cohort were compared to a cohort of patients who underwent surgical resection in the year prior to the implementation of the ERAS protocol. A feasibility analysis was performed among a sample of ERAS patients to determine the number of achieved items per patient. RESULTS Between 2008 and August 2010, 181 patients in our department underwent esophagectomy. Of these, 103 patients were included in the ERAS program (ERAS+ group) and were compared to 78 patients who had undergone an esophagectomy in 2008 (ERAS- group). Overall hospital stay was 14 days versus 15 days (ERAS+ and ERAS-, respectively; p = 0.013). There were no significant differences in the incidence of postoperative complications in either group. The percentage of achieved items varied between 42 and 93 % per item. CONCLUSIONS The implementation of an ERAS program in esophageal surgery was feasible and resulted in a small but significant reduction in overall hospital stay, whereas overall morbidity was not affected.
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Efficacy and safety of periprocedural dabigatran in patients undergoing catheter ablation of atrial fibrillation.
Kaseno, K, Naito, S, Nakamura, K, Sakamoto, T, Sasaki, T, Tsukada, N, Hayano, M, Nishiuchi, S, Fuke, E, Miki, Y, et al
Circulation journal : official journal of the Japanese Circulation Society. 2012;(10):2337-42
Abstract
BACKGROUND Periprocedural anticoagulation using uninterrupted warfarin could reduce the risk of thromboembolic complications of atrial fibrillation (AF) ablation. Few studies, however, have evaluated the efficacy and safety of periprocedural dabigatran in AF ablation. METHODS AND RESULTS A total of 211 consecutive patients who underwent AF ablation, including 110 patients who received 110mg dabigatran twice daily (group D) and 101 patients who received dose-adjusted warfarin (international normalized ratio, 2.0-3.0; group W), were evaluated. Dabigatran was discontinued on the morning of the procedure, and resumed on the next morning. Warfarin was continued throughout the procedure. During the procedure, heparin infusion was maintained to achieve an activated clotting time of >300s. Postprocedural cerebral magnetic resonance imaging (MRI) was performed in 60 patients (group D, n=31; group W, n=29). No periprocedural deaths or symptomatic thromboembolic complications were observed in either group. MRI indicated a silent cerebral infarction in 1 patient in each group. Five patients in group D and 11 in group W had minor bleeding (P=0.12). Cardiac tamponade occurred in 2 patients in group W, but in none in group D. Total bleeding complications occurred less frequently in group D (4.5%) than in group W (12.9%; P<0.05). CONCLUSIONS Dabigatran at a dose of 110mg twice daily was safe for AF ablation in patients with a relatively low risk of thromboemboli, suggesting that it may become an alternative to warfarin in those patients.
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Perioperative intravenous iron, with or without erythropoietin, plus restrictive transfusion protocol reduce the need for allogeneic blood after knee replacement surgery.
Cuenca, J, García-Erce, JA, Martínez, F, Pérez-Serrano, L, Herrera, A, Muñoz, M
Transfusion. 2006;(7):1112-9
Abstract
BACKGROUND Unilateral total knee replacement (TKR) results in a substantial blood loss and 30 to 50 percent of patients receive allogeneic blood transfusion (ABT). Therefore, the effectiveness of a restrictive transfusion trigger (hemoglobin [Hb] level < 8 g/dL) plus stimulation of erythropoiesis was evaluated, with or without blood salvage, for reducing ABT in TKR patients. STUDY DESIGN AND METHODS A series of 139 consecutive of primary TKR patients received perioperative iron sucrose (2 x 200 mg/48 hr, intravenously [IV]), plus preoperative erythropoietin (EPO; 1 x 40.000 UI, sc) if preoperative Hb level was less than 130 g per L (Group A). This protocol was applied to another series of 173 consecutive TKR patients who also received postoperative unwashed shed blood (USB) if preoperative Hb level was less than 130 g per L (Group B). Perioperative clinical and laboratory data were gathered. RESULTS No adverse effects of iron sucrose, EPO, or USB administration were witnessed, and only 13 patients received ABT overall (4%). No major differences in perioperative blood counts or iron metabolism variables were observed between groups, but stimulation of erythropoiesis seemed to be more pronounced in those patients receiving EPO (p < 0.05). There were no differences in postoperative complications between groups, but length of hospital stay for patients with a preoperative Hb level of less than 130 g per L was shorter in Group B (p < 0.05). CONCLUSION This blood saving protocol seems to be effective for reducing ABT in TKR patients. Which patients are more likely to benefit from either perioperative iron administration or selective addition of postoperative blood salvage to pharmacologic treatment, however, needs to be further evaluated.
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Effects of perioperative parenteral glutamine-dipeptide supplementation on plasma endotoxin level, plasma endotoxin inactivation capacity and clinical outcome.
Yao, GX, Xue, XB, Jiang, ZM, Yang, NF, Wilmore, DW
Clinical nutrition (Edinburgh, Scotland). 2005;(4):510-5
Abstract
BACKGROUND & AIMS We evaluated perioperative plasma endotoxin, plasma soluble CD14 molecule (sCD14), plasma endotoxin inactivation capacity (EIC) changes and clinical outcome after glutamine was provided in parenteral feedings to patients on whom gastrointestinal operations were performed using a prospective, randomized, double-blind study design. METHODS Forty patients undergoing gastrointestinal operations were randomized into two groups, each had 20 patients. One group received standard parenteral nutrition and the other received the same formulation but supplemented with the dipeptide alanyl-glutamine, the two groups were isonitrogenous. The infusion was started from 1 day before operation to the 3rd day after operation for 5 days. Blood samples were collected on the morning of 1 day before operation, 3h after operation, and on the morning of 1, 4 and 7 days after operation and analyzed for plasma endotoxin level, plasma sCD14 level and EIC. RESULTS There were no differences between the two groups on plasma endotoxin level. After surgery a rapid reduction in plasma EIC was observed in both groups, a significant restoration of the plasma EIC was observed on the morning of 1 and 4 days after surgery in the study group (0.12+/-0.02 and 0.078+/-0.022 EU/mL, respectively, P < 0.01). A significant rise in plasma sCD14 level was found in the study group on the morning of 1 and 4 days after surgery (14.32+/-1.69 and 10.34+/-1.14 microg/mL, respectively, P < 0.01). Shortened hospital stay was observed in the study group (11.7+/-2.0 days in the control group and 10.6+/-1.2 days on the study group respectively, P = 0.03). CONCLUSION Perioperative parenteral nutrition supplemented with dipeptide alanyl-glutamine ameliorated postoperative immunodepression without direct effect on endotoxemia.