A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus
Annals of surgical treatment and research. 2021;101(5):299-305
PURPOSE InnoSEAL Plus is an adhesive, coagulant-free hemostatic material that mimics the adhesion mechanism of marine mussels. This study reports on the safety and efficacy of InnoSEAL Plus for patients with hemorrhage after hepatectomy despite first-line hemostasis treatments. METHODS This is a multicenter, prospective, single-blinded, randomized clinical trial involving 96 hepatectomy patients. TachoSil was used as a comparator group. Three-minute and 10-minute hemostatic success rates were monitored. Rebleeding rates were also observed. Safety was assessed by recording all novel undesirable symptoms. RESULTS InnoSEAL Plus showed a 3-minute hemostasis rate of 100%, while TachoSil had a rate of 98.0% (48 of 49 patients), demonstrating that the 2 had similar hemostatic efficacies. The difference in efficacy between the test and comparator group was 2.04%, and the lower limit of the one-sided 97.5% confidence interval was -1.92%; as this is greater than the noninferiority limit of -23.9%, the 2 treatments were equivalent. Meanwhile, the 10-minute hemostatic success rate was the same in both groups (100%). No rebleeding occurred in either group. In the safety evaluation, 89 patients experienced adverse events (45 in the test group and 44 in the comparator group). The difference between the 2 groups was not significant. No death occurred after application of the test or comparator group product. CONCLUSION Given that InnoSEAL Plus is a coagulation factor-free product, the hemostasis results are encouraging, especially considering that TachoSil contains a coagulation factor. InnoSEAL Plus was found to be a safe and effective hemostatic material for control of bleeding in hepatectomy patients.
Assessment of recurrent anal fistulas treatment with platelet-rich plasma
Arquivos de gastroenterologia. 2021
BACKGROUND Surgical treatment of recurrent anal fistulas can lead to numerous complications, including fecal incontinence. Therefore, sphincter preserving techniques are gaining more popularity. OBJECTIVE The aim of the study was to assess effectiveness of platelet-rich plasma (PRP) therapy in the patients with recurrent cryptoglandular anal fistulas. METHODS A cohort of 18 patients with anal fistulas was enrolled into a preliminary and prospective trial. They were divided into two groups consisting of eight and ten patients respectively. PRP was injected locally in all patients, however in the group II it was applied after 7 days drainage of fistulas with polyurethane foam or negative pressure wound therapy. On average, three doses of PRP were administered, but with the opportunity to double the number of applications if it was clinically justified. The patients were evaluated in an out-patient department after fortnight and then in 1, 6, and 12 months following the last PRP application. RESULTS Anal fistulas were closed in 4 (50%) patients from the group I and in 7 (70%) patients form the group II. Although, the difference between both groups was not statistically significant, PRP therapy should be preceded with fistulous tract drainage in all patients. Summarizing, that successful result was achieved in 11 (60%) patients from the entire group of 18 participants. CONCLUSION The rate of recurrent cryptoglandular anal fistulas closure reaching 60%, after topical treatment with PRP, exceeds the results of other sphincter-saving methods of treatment. Therefore, it might become a novel method of anal fistulas therapy.
Impact of time to esophagogastroduodenoscopy in patients with nonvariceal upper gastrointestinal bleeding: A systematic review and meta-analysis
Revista de gastroenterologia de Mexico (English). 2021
INTRODUCTION There is conflicting evidence regarding the benefit of urgent esophagogastroduodenoscopy (EGD) for reducing mortality and rebleeding, in the context of nonvariceal upper gastrointestinal bleeding. AIM: To describe the decrease in the risk for mortality, rebleeding, and red blood cell transfusion, with the performance of urgent EGD, in patients with nonvariceal upper gastrointestinal bleeding. MATERIALS AND METHODS We carried out a search for cohort studies or controlled clinical trials, published from December 1966 to May 2020, that compared urgent EGD versus elective EGD in the management of adults with nonvariceal upper gastrointestinal bleeding, utilizing the MEDLINE, Embase, LILACS, and Cochrane Central Register of Controlled Trials databases. Our primary outcome was the hospital mortality comparison. The incidence of rebleeding and the mean number of red blood cell units transfused were also compared. A random effects model was utilized for the meta-analysis. RESULTS Twenty-one studies that met the eligibility criteria were included, involving 489,622 patients. We found no differences in the mortality of subjects exposed to urgent EGD versus elective EGD (RR 1.12 [0.72-1.72]). There was a significant increase in the risk for rebleeding (RR 1.30 [1.05-1.60]) in the subjects exposed to urgent EGD, and fewer red blood cell units were transfused in those patients (RR 0.52 [0.05-0.99]). CONCLUSIONS Urgent EGD in subjects with nonvariceal upper gastrointestinal bleeding does not appear to have a significant impact on short-term mortality.
Effect of Goal-Directed Crystalloid versus Colloid Administration on Perioperative Hemostasis in Partial Hepatectomy: A Randomized, Controlled Trial
Journal of clinical medicine. 2021;10(8)
The use of colloids may impair hemostatic capacity. However, it remains unclear whether this also holds true when colloids are administered in a goal-directed manner. The aim of the present study was to assess the effect of goal-directed fluid management with 6% hydroxyethyl starch 130/0.4 on hemostasis compared to lactated Ringer's solution in patients undergoing partial hepatectomy. We included 50 patients in this prospective, randomized, controlled trial. According to randomization, patients received boluses of either hydroxyethyl starch or lactated Ringer's solution within the scope of goal-directed fluid management. Minimum perioperative FIBTEM maximum clot firmness (MCF) served as the primary outcome parameter. Secondary outcome parameters included fibrinogen levels and estimated blood loss. In the hydroxyethyl starch (HES) group the minimum FIBTEM MCF value was significantly lower (effect size -6 mm, 95% CI -10 to -3, p < 0.001) in comparison to the lactated Ringer's solution (RL) group. These results returned to normal within 24 h. We observed no difference in plasma fibrinogen levels (RL 3.08 ± 0.37 g L(-1) vs HES 2.65 ± 0.64 g L(-1), p = 0.18) or the amount of blood loss between the two groups (RL 470 ± 299 mL vs HES 604 ± 351 mL, p = 0.18). We showed that goal-directed use of HES impairs fibrin polymerization in a dose-dependent manner when compared with RL. Results returned to normal on the first postoperative day without administration of procoagulant drugs and no differences in blood loss were observed.
Development and validation of a nomogram to predict intraoperative blood transfusion for gastric cancer surgery
Transfusion medicine (Oxford, England). 2021
OBJECTIVE To construct and validate a nomogram composed of preoperative variables to predict intraoperative blood transfusion for gastric cancer surgery. BACKGROUND Intraoperative transfusion for gastric cancer surgery is a common medical procedure that is associated with increased postoperative complications. METHODS A total of 999 patients who underwent gastrectomy between January 2010 and June 2019 were randomly allocated into the primary and validation cohorts in a 2:1 ratio. In the primary cohort, logistic analyses were performed to identify independent predictors for transfusion. Using the Akaike information criterion, selected variables were incorporated to construct a nomogram. Validations of the nomogram were performed in the primary and validation cohorts. The discrimination ability of the nomogram was assessed by the concordance index (C-index), and calibration was assessed by calibration curves and the Hosmer-Lemeshow goodness-of-fit test. RESULTS The following risk factors for transfusion were identified and used to construct the nomogram: ASA status (III-IV vs I-II: odds ratio [OR] 1.74), comorbidities (yes vs no: OR 1.57), tumour location (diffuse vs lower: OR 4.05), cTNM stage (III vs I: OR 1.95), and a preoperative haemoglobin level less than 80 g/L (vs over 120 g/L: OR 35.30). The C-index was 0.859 and 0.850 in the primary and validation cohorts, respectively, which both indicated good discrimination of the nomogram. Additionally, both calibration curves and Hosmer-Lemeshow tests (p-value 0.184 and 0.887, respectively) demonstrated high agreement between the predictions and actual outcomes. CONCLUSION A nomogram composed of preoperative variables to predict blood transfusion for gastric cancer surgery was effectively developed and validated. This nomogram could be used to improve the utilisation of red blood cells for gastrectomy.
Patients undergoing gastric cancer surgery (n= 999).
Nomogram of preoperative variables to predict intraoperative blood transfusion (primary cohort, n= 666).
Nomogram of preoperative variables to predict intraoperative blood transfusion (validation cohort, n= 333).
The following risk factors for transfusion were identified and used to construct the nomogram: American Society of Anaesthesiologists physical status, comorbidities, tumour location, Clinical Tumour-Lymph Node-Metastasis stage, and a preoperative haemoglobin level less than 80 g/L. The concordance index was 0.859 and 0.850 in the primary and validation cohorts, respectively, which both indicated good discrimination of the nomogram. Additionally, both calibration curves and Hosmer-Lemeshow tests demonstrated high agreement between the predictions and actual outcomes.
Early transjugular intrahepatic portosystemic shunt for acute variceal bleeding: a systematic review and meta-analysis
European radiology. 2021
OBJECTIVES The alleged benefit of early placement of transjugular intrahepatic portosystemic shunt (TIPS) in patients with cirrhosis and acute variceal bleeding (AVB) remains controversial. This meta-analysis was conducted to evaluate the therapeutic effect of early TIPS on cirrhotic patients with AVB. METHODS MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched for relevant literatures. Data from included studies were extracted, and random-effects meta-analyses were performed. RESULTS Three randomized control trials and six observational studies involving 2878 participants were included. Compared with those undergoing standard treatment, patients undergoing early TIPS had a significantly lower all-cause mortality (RR, 0.64; 95% CI, 0.52-0.79). Furthermore, early TIPS was associated with a significantly reduced incidence of failure to control bleeding (RR, 0.15; 95% CI, 0.07-0.29) and rebleeding (RR, 0.40; 95% CI, 0.23-0.71), without increasing the risk of hepatic encephalopathy (RR, 1.13; 95% CI, 0.92-1.38). In a stratification analysis based on Child-Pugh classification, the survival benefit was observed in Child-Pugh B patients with active bleeding (RR, 0.53; 95% CI, 0.31-0.93) and Child-Pugh C patients (RR 0.55, 95% CI, 0.37-0.82), but not in low-risk patients (Child-Pugh A and Child-Pugh B without active bleeding) (RR, 0.93; 95% CI, 0.55-1.57). CONCLUSION Early TIPS is a feasible therapeutic option for cirrhotic patients with AVB, especially benefiting high-risk patients in terms of improved survival. Given the current low utilization rate in clinical practice, this study favors the placement of early TIPS in a wider range of patients with cirrhosis and AVB, especially high-risk patients. KEY POINTS • Early TIPS is associated with improved survival in high-risk patients (Child-Pugh B plus active bleeding at endoscopy or Child-Pugh C 10-13) with cirrhosis and acute variceal bleeding. • Current utilization rate of early TIPS is low in clinical practice.
Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial
The lancet. Gastroenterology & hepatology. 2021
BACKGROUND Endoscopic mucosal resection (EMR) is a cornerstone in the management of large (≥20 mm) non-pedunculated colorectal polyps. Clinically significant post-EMR bleeding occurs in 7% of cases and is most frequently encountered in the right colon. We aimed to assess the use of prophylactic clip closure in preventing clinically significant post-EMR bleeding within the right colon. METHODS We conducted a randomised controlled trial at a tertiary centre in Australia. Patients referred for the EMR of large non-pedunculated colorectal polyps in the right colon were eligible. Patients were randomly assigned (1:1) into the clip or control (no clip) group, using a computerised random-number generator. The primary endpoint was clinically significant post-EMR bleeding, defined as haematochezia necessitating emergency department presentation, hospitalisation, or re-intervention within 14 days post-EMR, which was analysed on the basis of intention-to-treat principles. The trial is registered with ClinicalTrials.gov, NCT02196649, and has been completed. FINDINGS Between Feb 4, 2016, and Dec 15, 2020, 231 patients were randomly assigned: 118 to the clip group and 113 to the control group. In the intention-to-treat analysis, clinically significant post-EMR bleeding was less frequent in the clip group than in the control group (four [3·4%] of 118 patients vs 12 [10·6%] of 113; p=0·031; absolute risk reduction 7·2% [95% CI 0·7-13·8]; number needed to treat 13·9). There were no differences between groups in adverse events, including delayed perforation (one [<1%] in the clip group vs one [<1%] in the control group) and post-EMR pain (four [3%] vs six [5%]). No deaths were reported. INTERPRETATION Prophylactic clip closure can be performed following the EMR of large non-pedunculated colorectal polyps of 20 mm or larger in the right colon to reduce the risk of clinically significant post-EMR bleeding. FUNDING None.
Iron supplementation following bariatric surgery: A systematic review of current strategies
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2021
Iron deficiency (ID) and iron deficiency anemia (IDA) are common following bariatric surgery; however, there are limited standardized treatment recommendations for their management. The purpose of this study was to review the current strategies for iron supplementation following bariatric surgery and assess their relative efficacy in managing ID and IDA. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched to January 2021. Primary outcomes of interest were prevention or improvement in ID or IDA with iron supplementation. Forty-nine studies with 12,880 patients were included. Most patients underwent Roux-en-Y gastric bypass (61.9%). Iron supplementation was most commonly administered orally for prevention of ID/IDA and was effective in 52% of studies. Both IV and oral iron were given for treatment of ID/IDA. Fifty percent (3/6) of the oral and 100% (3/3) of the IV supplementation strategies were effective at treating ID. Iron supplementation strategies employed following bariatric surgery are highly variable, and many do not provide sufficient iron to prevent the development of ID and IDA, potentially due to poor patient adherence. Further high-quality prospective trials, particularly comparing intravenous and oral iron, are warranted in order to determine the ideal dosage, route, and duration of iron supplementation.
Evaluating the efficacy of bimanual compression of abdomen-flank to control postoperative bleeding after percutaneous nephrolithotomy: A randomized clinical trial
PURPOSE To investigate the influence of bimanual compression of abdomen-flank to control bleeding after completion of percutaneous nephrolithotomy (PCNL) including tubeless PCNL. MATERIALS AND METHODS This study is a parallel-group randomized clinical trial with 1:1:1 randomization. Ninety patients who were candidates for PCNL during July to October 2019 were enrolled. After completion of PCNL operation, patients were randomized into three groups to receive bimanual abdomen-flank compression for 0, 3, and 7 min by the operating surgeon with the opening of sealed envelopes (groups 0, 3, and 7 min afterwards). Preoperative, 24, and 48 h postoperative hemoglobin (Hb) and electrolytes were collected. The primary endpoint of interest was the comparison of 48-h blood loss across study groups. Secondary endpoints included the percent drop in 24- and 48-h Hb, transfusion rates, and operation complications. This trial is registered at www.irct.ir with the following number: IRCT20190618043925N1 on 18 July 2019. RESULTS There was no statistically significant difference in study groups regarding stone mass, stone location, access location, and patients' age (all p > 0.05). The medians (IQR) of 48-h blood loss were 490 mL (105-916), 338 mL (160-933), and 413 mL (71-650) in groups of 0, 3, and 7 min. The percent drop in 24-h postoperative Hb relative to preoperative Hb were 11.5 ± 8.6% versus 9.2 ± 7.3% versus 9.3 ± 6.8% (p = 0.44) and relative values for the percent drop in 48-h Hb relative to preoperative Hb were 8.6 ± 8.7% versus 9.5 ± 9.9% versus 7.2 ± 9.6% (p = 0.63) in groups of 0, 3, and 7 min respectively. Transfusion was needed in four patients in group 0 min, five patients in group 3 min, and three patients in group 7 min. CONCLUSIONS The results of this study reveal that postoperative bimanual compression of abdomen-flank has no statistically significant influence on the control of bleeding after PCNL operations.
Prophylactic transcatheter arterial embolization for high-risk ulcers following endoscopic hemostasis: a meta-analysis
World journal of emergency surgery : WJES. 2021;16(1):29
BACKGROUND To conduct a meta-analysis to assess the safety and efficacy of prophylactic transcatheter arterial embolization (PTAE) for the treatment of high-risk bleeding peptic ulcers after achieving endoscopic hemostasis. METHODS PubMed and Cochrane Library were queried for full-text articles published up to December 2019. The following keywords were used: "prophylactic embolization", "supplement embolization", "gastrointestinal bleeding", and "ulcer bleeding". High-risk ulcers were defined based on endoscopic findings (i.e., large ulcers, Forrest class I-IIb) and/or clinical presentation (i.e., hypotension, decreased hemoglobin during endoscopy). Only comparative studies investigating PTAE versus conservative treatment after achieving endoscopic hemostasis were included. Baseline study characteristics, rebleeding rate, need for surgery, mortality, and PTAE-related complication rates were investigated. Quantitative analyses were performed with Stata 15.1. RESULTS Among the five included original studies, a total of 265 patients received PTAE and 617 were managed conservatively after endoscopy. The rebleeding rate (6.8% vs 14.3%, p = 0.003) and mortality (4.5% vs 8.8%, p = 0.032) of patients from the PTAE group were lower than the control group. PTAE also reduced the cumulative need for future surgical intervention (3.0% vs 14.4%, p = 0.005). The PTAE-related major and minor events were 0.75% and 14.4%, respectively. CONCLUSION PTAE had therapeutic potentials in reducing rebleeding risk, need for surgical intervention, and morality in high-risk peptic ulcers after achieving endoscopic hemostasis. The embolization-associated adverse events were minimal. Future studies should aim to increase the sample size and resources for performing endovascular interventions.