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.
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.
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.
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.
Mesh fixation with fibrin glue versus tacker in laparoscopic totally extraperitoneal inguinal hernia repair
ANZ journal of surgery. 2021
BACKGROUND The advent of mesh was a breakthrough in the field of hernia surgery. Mechanical methods of mesh fixation are hypothesized to cause more tissue trauma than nonmechanical methods. The present study was conducted to study the outcomes of mesh fixation using fibrin glue, a nonmechanical method versus tackers in totally extraperitoneal repair (TEP) of unilateral inguinal hernia. METHODS A randomized controlled single blinded study was conducted in India from June 2017 to March 2019. Patients diagnosed with unilateral uncomplicated inguinal hernia with a hernial sac of size not more than 5 cm were invited to participate in the study. Sample size was 60 patients randomized into groups just before mesh fixation. In group A mesh was fixed using tackers while in group B mesh was fixed using fibrin glue. Patients were followed-up prospectively for 3 months. RESULTS There was no statistical difference between the two groups with respect to operating time. Average hospital stay and pain scores at all follow-ups were better for fibrin glue group. There was no difference in the incidence of postoperative urinary retention, seroma formation and hematoma formation between the two groups. Patients of fibrin glue group had early restart of daily activities at 15 days follow-up when compared to tacker group. CONCLUSION Fibrin glue fixation technique should be advocated over tackers for mesh fixation in TEP considering the better outcomes and cost-effectiveness of the technique.
Efficacy and Safety of Infrahepatic Inferior Vena Cava Clamping under Controlled Central Venous Pressure for Reducing Blood Loss During Hepatectomy: A Randomized Controlled Trial
Journal of hepato-biliary-pancreatic sciences. 2021
BACKGROUND The purpose of this study was to evaluate the effectiveness and safety of inferior vena cava (IVC) clamping for reducing blood loss during hepatectomy. METHODS In total, 120 elective hepatectomy patients who underwent surgery from May 2016 to October 2017 were enrolled and randomized into the IVC clamping group or nonclamping group. Both groups were managed by anesthesiological techniques for CVP reduction. Blood loss and clinical parameters were analyzed for 30 days after surgery. RESULTS Fifty-nine patients were assigned to the IVC clamping group and 61 to the non-IVC clamping group. There was a significant difference in the total blood loss between both groups, with less blood loss observed in the IVC clamping group [500 ml vs 600 ml, p = 0.006]. The transection blood loss in the IVC clamping group was also significantly lower than that in the non-IVC clamping group [300 ml vs 500 ml, p < 0.001]. However, CVP was not associated with blood loss volume. Postoperative outcomes were not significant in either group. CONCLUSIONS IVC clamping is beneficial for reducing blood loss during hepatectomy and is safe when combined with anesthesiological techniques. If feasible, this technique should be used regardless of the CVP value.
Physiological and Clinical Impact of Repeated Inhaled Oxygen Variation on Erythropoietin Levels in Patients After Surgery
Frontiers in physiology. 2021;12:744074
The "Normobaric Oxygen Paradox" (NOP) is a physiologic mechanism that induces an increase of endogenous erythropoietin (EPO) production by creating a state of relative hypoxia in subjects previously exposed to hyperoxia, followed by a rapid return to normoxia. Oxygen exposure duration and inspired oxygen fraction required to observe a significant increase in EPO or hemoglobin are not clearly defined. Consequently, we here study the effect of one model of relative hypoxia on EPO, reticulocytes and hemoglobin stimulation in patients after surgery. Patients were prospectively randomized in two groups. The O(2) group (n = 10) received 100% oxygen for 1 h per day for eight consecutive days, via a non-rebreathing mask. The control group (n = 12) received no oxygen variation. Serum EPO, hemoglobin and reticulocyte count were measured on admission and postoperatively on days seven and nine. Percentage EPO at day nine with respect to the baseline value was significantly elevated within the groups [O(2) group: 323.7 (SD ± 139.0); control group: 365.6 (SD± 162.0)] but not between them. No significant difference was found between the groups in terms of reticulocytes count and hemoglobin. Our NOP model showed no difference on EPO increase between the two groups. However, both groups expressed separately significant EPO elevation.
Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;136:111251
BACKGROUND Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding. METHODS This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%. RESULTS 526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005). CONCLUSION The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.