-
1.
Identification of risk factors for morbidity and mortality after Hartmann's reversal surgery - a retrospective study from two French centers.
Christou, N, Rivaille, T, Maulat, C, Taibi, A, Fredon, F, Bouvier, S, Fabre, A, Derbal, S, Durand-Fontanier, S, Valleix, D, et al
Scientific reports. 2020;(1):3643
Abstract
Hartmann's reversal procedures are often fraught with complications or failure to recover. This being a fact, it is often difficult to select patients with the optimal indications for a reversal. The post-recovery morbidity and mortality rates in the literature are heterogeneous between 0.8 and 44%. The identification of predictive risk factors of failure of such interventions would therefore be very useful to help the practitioner in his approach. Given these elements, it was important to us to analyze the practice of two French university hospitals in order to highlight such risk factors and to allow surgeons to select the best therapeutic strategy. We performed a bicentric observational retrospective study between 2010 and 2015 that studied the characteristics of patients who had undergone Hartmann surgery and were subsequently reestablished. The aim of the study was to identify factors influencing morbidity and postoperative mortality of Hartmann's reversal. Primary outcome was complications within the first 90 postoperative days. 240 patients were studied of which 60.4% were men. The mean age was 69.48 years. The median time to reversal was 8 months. 79.17% of patients were operated as emergency cases where the indication was a diverticular complication (39.17%). Seventy patients (29.2%) underwent a reversal and approximately 43% of these had complications within the first 90 postoperative days. The mean age of these seventy patients was 61.3 years old and 65.7% were males. None of them benefited from a reversal in the first three months. We identified some risk factors for morbidity such as pre-operative low albuminemia (p = 0.005) and moderate renal impairment (p = 0.019). However, chronic corticosteroid use (p = 0.004), moderate renal insufficiency (p = 0.014) and coronary artery disease (p = 0.014) seem to favour the development of anastomotic fistula, which is itself, a risk factor for mortality (p = 0.007). Our study highlights an important rate of complications including significant anastomotic fistula after Hartmann's reversal. Precarious nutritional status and cardiovascular comorbidities should clearly lead us to reconsider the surgical indication for continuity restoration.
-
2.
The predictive value of coronary artery calcium detected by computed tomography in a prospective study on cardiac allograft vasculopathy in heart transplant patients.
Günther, A, Andersen, R, Gude, E, Jakobsen, J, Edvardsen, T, Sandvik, L, Abildgaard, A, Aaberge, L, Gullestad, L
Transplant international : official journal of the European Society for Organ Transplantation. 2018;(1):82-91
Abstract
The predictive value of coronary artery calcium (CAC) in heart transplant (HTX) patients is not established. We explored if the absence of CAC on computed tomography (CT) could exclude moderate and severe cardiac allograft vasculopathy [CAV2-3 ; the International Society for Heart and Lung Transplantation (ISHLT) recommended nomenclature] and significant coronary artery stenosis (diameter reduction ≥50%) and predict long-term clinical outcomes. HTX recipients (n = 133) were prospectively included and underwent CT for CAC scoring and invasive coronary angiography (ICA) 7.8 ± 5.0 years after HTX. CAC was detected in 73 (55%) patients. The absence of CAC on CT had a negative predictive value of 97% for ISHLT CAV2-3 and 88% for significant stenosis on ICA. During 7.5 ± 2.6 years of follow-up after CAC CT (n = 127), there were 57 (45%) nonfatal major adverse cardiac events and 23 (18%) deaths or graft losses registered as first events. Patients with CAC had significantly more events (P = 0.011). In an adjusted Cox regression analysis, the presence of CAC was significantly associated with a negative outcome (HR 1.8, 95% CI 1.1-3.0; P = 0.023). The absence of CAC predicted low prevalences of ISHLT CAV2-3 and significant coronary artery stenosis in HTX patients. The presence of CACS was significantly associated with a worse long-term outcome.
-
3.
EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?
Patel, N, Mohanaruban, A, Ashrafian, H, Le Roux, C, Byrne, J, Mason, J, Hopkins, J, Kelly, J, Teare, J
Obesity surgery. 2018;(7):1980-1989
-
-
Free full text
-
Abstract
BACKGROUND AND AIMS Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2 and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
-
4.
Comparison of enteral versus intravenous potassium supplementation in hypokalaemia in paediatric patients in intensive care post cardiac surgery: open-label randomised equivalence trial (EIPS).
Rehman Siddiqu, NU, Merchant, Q, Hasan, BS, Rizvi, A, Amanullah, M, Rehmat, A, Ul Haq, A
BMJ open. 2017;(5):e011179
Abstract
OBJECTIVES The primary objective was to compare the efficacy of enteral potassium replacement (EPR) and intravenous potassium replacement (IVPR) as first-line therapy. Secondary objectives included comparison of adverse effects and number of doses required to resolve the episode of hypokalaemia. TRIAL DESIGN The EIPS trial is designed as a randomised, equivalence trial between two treatment arms. STUDY SETTING The study was conducted at the paediatric cardiac intensive care unit (PCICU) at Aga Khan University Hospital, Karachi. PARTICIPANTS 41 patients (aged 1 month to 15 years) who were admitted to PCICU post cardiac surgery were recruited (23 IVPR arm and 18 EPR arm). INTERVENTION Intervention arms were block randomised on alternate weeks for IVPR and EPR. OUTCOME MEASURE Change in serum potassium levels in (mmol/L) and percentage change after each event of potassium replacement by the intravenous or enteral route. RESULTS Both groups (41 patients) had similar baseline characteristics. Mean age was 4.7 (SD±4) years while the most common surgical procedure was ventricular septal defect repair (12 patients, 29.3%). No mortality was observed in either arm. Four episodes of vomiting and one arrhythmia were seen in the EPR group. After adjusting for age, potassium level at the beginning of the episode, average urine output, inotropic score and diuretic dose, it was found that there was no statistically significant difference in change in potassium levels after EPR and IVPR 0.86 mmol/L (±0.8) and 0.82 mmol/L (±0.7) respectively (p=0.86, 95% CI -0.08 to 1.10), or percentage change in potassium level after enteral and intravenous replacement: 26% (±30) and 24% (±20) (95% CI -3.42 to 4.03, p=0.87). CONCLUSION EPR may be an equally efficacious alternative first-line therapy in treating hypokalaemia after surgery in selective patients with congenital heart disease. ETHICS AND DISSEMINATION This study has been approved by Ethics Review Committee at AKU. TRIAL REGISTRATION NUMBER NCT02015962.
-
5.
Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.
Kim, YW, Bae, JM, Park, YK, Yang, HK, Yu, W, Yook, JH, Noh, SH, Han, M, Ryu, KW, Sohn, TS, et al
JAMA. 2017;(20):2097-2104
-
-
Free full text
-
Abstract
IMPORTANCE Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01725789.
-
6.
Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study.
Le Roy, B, Pereira, B, Bouteloup, C, Costes, F, Richard, R, Selvy, M, Pétorin, C, Gagnière, J, Futier, E, Slim, K, et al
BMJ open. 2016;(12):e012876
Abstract
INTRODUCTION Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment. METHODS AND ANALYSIS The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received. ETHICS AND DISSEMINATION The study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT02780921.
-
7.
Ketorolac Tromethamine Spray Prevents Postendotracheal-Intubation-Induced Sore Throat after General Anesthesia.
Yang, HL, Liu, FC, Tsai, SC, Tsay, PK, Lin, HT, Liu, HE
BioMed research international. 2016;:4582439
Abstract
Background. Postoperative sore throat is one of the major complaints of general anesthesia in the postanesthesia care unit. This prospective study investigated the preventive effect of ketorolac tromethamine spray in postendotracheal-intubation-induced sore throat after general anesthesia. Methods. Surgical patients undergoing general anesthesia with endotracheal intubation were recruited from a medical center. Patients were randomly assigned to group K (treated with 5% ketorolac tromethamine spray) or group D (treated with distilled water spray). Before intubation, each endotracheal tube was sprayed with the appropriate solution by physicians over the 20 cm length of the cuff. Each group comprised 95 patients fitting the inclusion and exclusion criteria for whom complete data sets were collected. The intensity of the sore throat was measured at 1, 3, 6, and 24 h after surgery, and data were compared. Results. The two groups had similar characteristics. Postoperative sore throat was significantly less frequent in group K than in group D (p < 0.001) and the pain intensity was significantly lower in group K than in group D at each time point (all p < 0.001). Conclusions. This study demonstrated that preanesthesia 5% ketorolac tromethamine spray could effectively decrease postendotracheal-intubation-induced sore throat in patients undergoing general anesthesia.
-
8.
Vonoprazan prevents bleeding from endoscopic submucosal dissection-induced gastric ulcers.
Kagawa, T, Iwamuro, M, Ishikawa, S, Ishida, M, Kuraoka, S, Sasaki, K, Sakakihara, I, Izumikawa, K, Yamamoto, K, Takahashi, S, et al
Alimentary pharmacology & therapeutics. 2016;(6):583-91
-
-
Free full text
-
Abstract
BACKGROUND Vonoprazan, a potassium-competitive acid blocker, is expected to improve the healing of endoscopic submucosal dissection (ESD)-induced gastric ulcers compared with proton pump inhibitors (PPIs). AIM: To compare the healing status of ESD-induced gastric ulcers and the incidence of post-ESD bleeding between subjects treated with vonoprazan for 5 weeks and those treated with PPIs for 8 weeks. METHODS Patients in the vonoprazan group (n = 75) were prospectively enrolled, whereas patients in the PPI group (n = 150) were selected for a 2:1 matched historical control cohort according to baseline characteristics including gastric ulcer size immediately following ESD, age, sex and status of Helicobacter pylori infection. Two controls per case of vonoprazan-treated group were matched with a margin of 20% in terms of ulcer size and a margin of 5 years in terms of their age. RESULTS Although a higher number of completely healed ulcers was observed in the PPI group (95/150, 63.3%) than that in the vonoprazan group (14/75, 18.7%; P < 0.001), the ulcer size reduction rates, which were 96.0 ± 6.7% in the vonoprazan group and 94.7 ± 11.6% in the PPI group, were not significantly different (P = 0.373). The post-ESD bleeding incidence in the vonoprazan group (1/75, 1.3%) was less than that in the PPI group (15/150, 10.0%; P = 0.01). The factors affecting post-ESD bleeding incidence were the type of acid secretion inhibitor (P = 0.016) and use of an anti-thrombotic agent (P = 0.014). CONCLUSION Vonoprazan significantly reduced post-endoscopic submucosal dissection bleeding compared with PPIs.
-
9.
A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.
Knitsch, W, Vincent, JL, Utzolino, S, François, B, Dinya, T, Dimopoulos, G, Özgüneş, İ, Valía, JC, Eggimann, P, León, C, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2015;(11):1671-8
-
-
Free full text
-
Abstract
BACKGROUND Patients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at risk of invasive candidiasis (IC) and candidates for preemptive antifungal therapy. METHODS This exploratory, randomized, double-blind, placebo-controlled trial assessed a preemptive antifungal approach with micafungin (100 mg/d) in intensive care unit patients requiring surgery for intra-abdominal infection. Coprimary efficacy variables were the incidence of IC and the time from baseline to first IC in the full analysis set; an independent data review board confirmed IC. An exploratory biomarker analysis was performed using logistic regression. RESULTS The full analysis set comprised 124 placebo- and 117 micafungin-treated patients. The incidence of IC was 8.9% for placebo and 11.1% for micafungin (difference, 2.24%; [95% confidence interval, -5.52 to 10.20]). There was no difference between the arms in median time to IC. The estimated odds ratio showed that patients with a positive (1,3)-β-d-glucan (ßDG) result were 3.66 (95% confidence interval, 1.01-13.29) times more likely to have confirmed IC than those with a negative result. CONCLUSIONS This study was unable to provide evidence that preemptive administration of an echinocandin was effective in preventing IC in high-risk surgical intensive care unit patients with intra-abdominal infections. This may have been because the drug was administered too late to prevent IC coupled with an overall low number of IC events. It does provide some support for using ßDG to identify patients at high risk of IC. CLINICAL TRIALS REGISTRATION NCT01122368.
-
10.
Haemostatic and fibrinolytic changes in obese subjects undergoing bariatric surgery: the effect of different surgical procedures.
Lupoli, R, Milone, M, Di Minno, A, Maietta, P, Ambrosino, P, Musella, M, Di Minno, MN
Blood transfusion = Trasfusione del sangue. 2015;(3):442-7
Abstract
BACKGROUND Little is known about effects of different bariatric surgery procedures on haemostatic and fibrinolytic parameters. MATERIAL AND METHODS Consecutive obese subjects undergoing gastric bypass (GBP) or sleeve gastrectomy (SG) were enrolled. In all patients, levels of haemostatic factors (FII, FVII, FVIII, FIX, FX, vWF, fibrinogen), fibrinolytic variables (PAI-1, t-PA and D-dimer) and natural anticoagulants (AT, protein C and protein S) were evaluated before and 2 months after surgery. RESULTS A total of 77 GBP and 79 SG subjects completed the study. At baseline no difference in coagulation parameters was found between the two groups. After both GBP and SG, subjects showed significant changes in haemostatic and fibrinolytic variables and in natural anticoagulant levels. The Δ% changes in FVII, FVIII, FIX, vWF, fibrinogen, D-dimer, protein C and protein S levels were significantly higher in subjects who underwent GBP than in those who underwent SG. Multivariate analysis confirmed that GBP was a predictor of higher Δ% changes in FVII (β=0.268, p=0.010), protein C (β=0.274, p=0.003) and protein S (β=0.297, p<0.001), but not in all the other variables. Following coagulation factor reduction, 31 subjects (25.9% of GBP and 13.9% of SG; p=0.044) showed overt FVII deficiency; protein C deficiency was reported by 34 subjects (32.5% of GBP vs 11.4% of SG, p=0.033) and protein S deficiency by 39 (37.6% of GBP vs 12.6% of SG, p=0.009). Multivariate analyses showed that GBP was associated with an increased risk of deficiency of FVII (OR: 3.64; 95% CI: 1.73-7.64, p=0.001), protein C (OR: 4.319; 95% CI: 1.33-13.9, p=0.015) and protein S (OR: 5.50; 95% CI: 1.71-17.7, p=0.004). DISCUSSION GBP is associated with an increased risk of post-operative deficiency in some vitamin K-dependent coagulation factors. Whereas such deficiency is too weak to cause bleeding, it is significant enough to increase the risk of thrombosis.