Preemptive Administration of Albumin during Pancreatectomy Does Not Reduce Postoperative Complications: A Prospective Randomized Controlled Trial
Journal of clinical medicine. 2022;11(3)
Despite the empirical use of human albumin during pancreatectomy to replace intraoperative volume loss while preventing fluid overload and edema, its impact on postoperative outcomes remains unclear. In addition, most previous studies have focused on the effects of therapeutic albumin usage. Here, we investigated whether preemptive administration of human albumin to prevent edema during pancreatectomy could reduce the incidence of moderate postoperative complications. Adult patients undergoing pancreatectomy were assigned to either the albumin group (n = 100) or the control group (n = 100). Regardless of the preoperative albumin level, 200 mL of 20% albumin was administered to the albumin group after induction of anesthesia. The primary outcome was the incidence of moderate postoperative complications as defined by a Clavien-Dindo classification grade ≥ 2 at discharge. Intraoperative net-fluid balance, a known risk factor of postoperative complication after pancreatectomy, was lower in the albumin group than in the control group (p = 0.030), but the incidence of moderate postoperative complications was not different between the albumin and control groups (47/100 vs. 38/100, respectively; risk ratio: 1.24, 95% CI: 0.89 to 1.71; p = 0.198). Therefore, preemptive administration of human albumin to prevent fluid overload and edema during pancreatectomy is not recommended because of its lack of apparent benefit in improving postoperative outcomes.
Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2021
Background: There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Methods: Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Results: Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Conclusion: Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).
New Technique of Posterior Fixation of Tube With Fibrin Sealant Prevents Dysphagia in Patients Undergoing Sleeve Gastrectomy
The American surgeon. 2021;:3134821991989
INTRODUCTION This study compared the effects of posterior fixation (PF) of the remnant tube with fibrin tissue glue to prevent sharp angulation and gastric twist and traditional techniques on postoperative dysphagia and vomiting. METHODOLOGY In total, 200 patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) as a bariatric surgical intervention were randomly classified into 2 groups (LSG + PF and LSG alone). We compared postoperative dysphagia symptoms among patients who underwent PF and those who did not. The Dysphagia Handicap Index (DHI) results were compared statistically among these groups. RESULTS The study included a total of 191 patients (85.9% (n = 164) women and 14.1% (n = 27) men) who underwent LSG for obesity. The groups were similar in terms of the patient demographics. The DHI scores of the LSG + PF group were statistically significantly lower than those of the LSG alone group. CONCLUSION Adoption of a standardized method of PF with a standardized surgical procedure after LSG considerably reduced the rate of surgical complications.
Safety and efficacy of human serum albumin treatment in patients with cirrhotic ascites undergoing paracentesis: A systematic review and meta-analysis
Annals of hepatology. 2021;26:100547
Ascites is the most common presentation of decompensated liver cirrhosis. It is treated with therapeutic paracentesis which is associated with several complications. The role of human albumin in patients with cirrhotic ascites remains elusive and has been extensively studied with conflicting results. Thus, in order to fully appraise the available data we sought to perform this systematic review and meta-analysis. Herein we included studies comparing the efficacy and safety of human albumin comparing with other volume expanders and vasoactive agents in patients undergoing paracentesis in cirrhotic ascites. Odds ratio (OR) and mean difference (MD) were used to estimate the outcome with a 95% confidence interval (CI). Albumin use reduced the odds of paracentesis induced circulatory dysfunction (PICD) by 60% (OR 0.40, 95% CI 0.27-0.58). While performing subgroup analysis, albumin use lowered the odds of PICD significantly (OR 0.34, 95% CI 0.22-0.52) in comparison to other colloid volume expanders, but did not lower the odds of PICD in comparison to vasoconstrictor therapy (OR 0.93, 95% CI 0.35-2.45). Albumin was associated with a statistically significant lower incidence of hyponatremia (OR 0.59, 95% CI 0.39-0.88). Albumin did not reduce the overall mortality, readmission rate, recurrence of ascites, mean arterial pressure, incidence of renal impairment, hepatic encephalopathy, and gastrointestinal (GI) bleeding. Thus, treatment with albumin in cirrhotic ascites reduced PICD and hyponatremia although there was no benefit in terms of mortality, readmission rate, recurrence of ascites, hepatic encephalopathy, and GI bleeding.
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.
Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery
Journal of anesthesia. 2020
PURPOSE The aim of this study was to evaluate the effects of hydroxyethyl starch (HES) 130/0.4/9 compared to 5% albumin on renal and coagulation safety profiles, volume efficacy and glycocalyx degradation in major abdominal surgery. METHODS The study was approved by the institutional ethics committee as a single center, open-labeled randomized trial. Fifty patients undergoing hepatic or pancreatic surgery were randomly assigned to the HES group (n = 25), who received HES 130/0.4/9, or the Albumin group (n = 25), who received 5% albumin. Ringer's acetate solution (3 ml/kg/h) and colloid solution (2 mL/kg/h) were infused and goal-directed fluid management was performed to stabilize hemodynamics. Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups. Blood loss and requirements for transfusion and vasoactive agents were also examined. Statistical analysis was performed by Mann-Whitney U tests, chi-square or Fisher exact test, with P < 0.05 taken to be significant. RESULTS Serum creatinine levels did not differ between the HES and Albumin groups (median: 0.67 vs. 0.75 mg/dL at anesthesia induction, 0.82 vs. 0.83 mg/dL at ICU admission, 0.67 vs. 0.73 mg/dL one day after surgery, 0.68 vs. 0.70 mg/dL one month after surgery). NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents did not differ between the groups. CONCLUSION HES 130/0.4/9 can be used as safely and effectively as 5% albumin. Glycocalyx degradation did not differ between use of these solutions in major abdominal surgery.
Efficacy of Fibrin Sealant in Reducing Complication Risk After Bariatric Surgery: a Systematic Review and Meta-analysis
Obesity surgery. 2020
BACKGROUND Complications including staple-line leakage and bleeding may occur after sleeve gastrectomy and Roux-en-Y gastric bypass. In this meta-analysis, the efficacy of fibrin sealant in strengthening the staple line and reducing complication risk after bariatric surgery was evaluated. METHODS We searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) published up to October 2020. Pooled estimates of the outcomes were computed using a random effects model. The primary outcomes were bleeding and leakage; secondary outcomes were gastric stricture, length of hospital stay, reoperation rate, and total operation time. RESULTS In total, 9 RCTs including 2136 patients were reviewed. Our meta-analysis revealed that compared with controls, fibrin sealants decreased incidence of bleeding significantly (risk ratio [RR] = 0.42; 95% confidence interval [CI], 0.18-0.97), but did not demonstrate significant differences in reducing the incidence of leakage (RR = 0.62; 95% CI, 0.23-1.73), gastric stricture (RR = 1.16; 95% CI, 0.46-2.91), reoperation rate (RR = 0.85; CI, 0.14-5.14), or length of hospital stay (weighted mean difference = 0.62; 95% CI, - 0.31 to 1.55). Compared with oversewing, fibrin sealant use reduced the operation time; however, their efficacies in reducing the incidence of postoperative bleeding and leakage did not differ significantly. CONCLUSIONS Although applying fibrin sealants to the staple line in bariatric surgery may provide favorable results, but it may not reduce postoperative leakage and stricture incidence significantly. Nevertheless, the application of fibrin sealants as a method for reducing risks of complications after bariatric surgery warrant further investigation.
A Randomized Controlled Trial Comparing Short-term Outcomes of Self-Gripping (Progrip) Mesh Versus Fibrin Sealant in Laparoscopic Total Extraperitoneal Hernioplasty
Surgical laparoscopy, endoscopy & percutaneous techniques. 2020
BACKGROUND There are no data comparing the use of self-gripping mesh with standard mesh in total extraperitoneal repair (TEP). In this prospective study we aim to study the incidence of chronic pain between Progrip (PG) and standard mesh fixed by fibrin sealant (FS). MATERIALS AND METHODS Under Institutional Review Board approval, from April 2016 to May 2017, patients with primary unilateral or bilateral inguinal hernia eligible for TEP were recruited. Before mesh insertion they were randomized into PG or FS (Tisseel). Demographics, intraoperative, and postoperative data were recorded. Patients were followed up for at least 1 year. Visual Analog Scale was used to record pain scores. Primary outcome was the incidence of chronic pain at 3 months after surgery. RESULTS One hundred fifty patients were randomized. Of the 150 patients (193 hernias), 76 were randomized to PG and 74 randomized to FS. Demographic data such as age, presence of comorbidities, smoking history, mean body mass index was comparable in both groups. Bilateral hernias occurred in 25 (32.9%) and 18 (24.3%) patients in PG and FS group, respectively. Mean mesh deployment time was 283.7 seconds (range, 140 to 720 s) in PG group and 301.9 seconds (range, 67 to 1006 s) in FS group (P=0.30). A total of 5 patients were lost at follow-up and they were excluded from subsequent data analysis. Seroma occurred in 15 (20.3%) and 16 (22.5%) patients in PG and FS group, respectively (P=0.45). Mean Visual Analog Scale at 2 weeks (cough) was highest at 1.05 and 1.02 in PG and FS group, respectively (P=0.62). Eight (12.3%) and 15 (23.4%) patients in PG and FG group, respectively, reported pain at 3-month follow-up (P=0.1). Of those who experienced pain, majority was mild pain which did not affect activities of daily living. At a mean follow-up of 13.1+/-5.4 months, no recurrence was detected. CONCLUSIONS There was no significant difference in terms of chronic pain between PG and FS group. The use of PG is effective in TEP.
Goal-directed therapy with bolus albumin 5% is not superior to bolus ringer acetate in maintaining systemic and mesenteric oxygen delivery in major upper abdominal surgery: A randomised controlled trial
European journal of anaesthesiology. 2020
BACKGROUND Goal-directed therapy (GDT) is increasingly used in abdominal surgery. Whether crystalloids can exert the same effect as colloid, and how this may affect perfusion, is still unclear. The effect of GDT on the systemic oxygen delivery index (sDO2I) and the mesenteric oxygen delivery index (mDO2I) can be quantified by measuring cardiac index and flow in the superior mesenteric artery, respectively. OBJECTIVE The aim of this study was to test the hypothesis that intra-operative GDT with bolus human albumin 5% is superior to GDT with bolus ringer acetate in maintaining sDO2I and mDO2I in elective major upper gastrointestinal cancer surgery. DESIGN Randomised controlled double blinded trial. SETTING Odense University Hospital, Denmark, from May 2014 to June 2015. PATIENTS A total of 89 adults scheduled for elective major upper gastrointestinal cancer surgery were randomised and data from 60 were analysed. EXCLUSION CRITERIA contraindications for using the LiDCOplus system, known allergy to albumin, pre-operative renal failure, pancreatic cancer and pre-operative down staging using chemotherapy and/or radiation therapy, pregnancy. INTERVENTIONS Patients were randomised to intra-operative GDT with either bolus human albumin or ringer acetate 250 ml, guided by pulse pressure variation and stroke volume. MAIN OUTCOME MEASURES Changes in sDO2I and mDO2I. Secondary outcomes were changes in other haemodynamic variables, fluid balance, blood transfusions, fluid-related complications and length of stay (LOS) in ICU and hospital. RESULTS Median [IQR] sDO2I was 522 [420 to 665] ml min m in the ringer acetate group and 490 [363 to 676] ml min m in the human albumin group, P = 0.36. Median [IQR] mDO2I was 12.1 [5.8 to 28.7] ml min m in the ringer acetate group and 17.0 [7.6 to 27.5] ml min m in the human albumin group, P = 0.17. Other haemodynamic comparisons did not differ significantly. More trial fluid was administered in the ringer acetate group. We found no significant difference in transfusions, complications or LOS. CONCLUSION Bolus human albumin 5% was not superior to bolus ringer acetate in maintaining systemic or mesenteric oxygen delivery in elective major upper gastrointestinal cancer surgery, despite the administration of larger volumes of trial fluid in the ringer acetate group. No significant difference was seen in fluid-related complications or LOS. TRIAL REGISTRATION https://eudract.ema.europa.eu/ Identifier: 2013-002217-36.
Costs Analysis of Fibrin Sealant for Prevention of Anastomotic Leakage in Lower Colorectal Surgery
Risk management and healthcare policy. 2020;13:5-11
Introduction: Postoperative anastomotic leaks remain a common and serious complication of colorectal surgeries and are a major cause of mortality and morbidity of these procedures. Anastomotic leaks (AL) have been extensively studied; however, there has been no significant reduction in their prevalence over time. In addition, there is a significant economic burden from AL attributed to the need for repeat surgery, radiologic intervention and lengthened hospital stay. We conducted a comparative cost analysis of patients undergoing colorectal surgery with anastomosis, with the application of fibrin sealant (FS) to the sutured anastomosis versus not treating the sutured anastomosis with FS. Methods: The deterministic decision-tree model was populated with clinical data including operating room time, hospitalization days, occurrence of AL, need for revision surgery, blood products and radiologic interventions to treat the AL in lower colorectal surgery. A systematic literature review was conducted to identify appropriate studies with these variables. Results: The average cost per case treated lower colorectal surgery with fibrin sealant glue 10 mL Tisseel((R)) and those not treated with a fibrin sealant after suturing the anastomoses was euro3233 and euro4130, respectively, for resource expenses paid by the healthcare system. This would suggest potential savings of euro897 per surgery, achieved through the application of FS to the sutured anastomosis for preventing AL following colorectal surgery. Conclusion: Application of FS to the sutured anastomosis in lower colorectal surgery resulted in a decrease in post-operative AL, and cost savings based on a reduction in hospitalization days, a reduction needing: revision surgery, radiologic intervention and blood products to treat AL.