METHODS: This is a double-blind randomized clinical trial, involving 26 patients with CRSwNP, who underwent FESS for failed medical therapy. The intervention nostril was packed with ribbon gauze soaked in 500 mg/5 ml TXA. The control nostril was packed with ribbon gauze soaked in Moffett's solution, containing 2 ml 10% cocaine, 1 ml adrenaline 1:1000, and 4 ml 0.9% sodium bicarbonate. Both nostrils were packed for 15 min before FESS. Intraoperative bleeding was recorded in the initial 30 min after commencing the surgery. The recordings were reviewed by two surgeons using Boezaart's scoring system. The scores were taken at 15 and 30 min of surgery. The mean score was then calculated. At the end of the surgery, the intervention nostril was packed with Merocel® soaked in 500 mg/5 ml TXA and the control nostril was packed with Merocel® soaked in normal saline. The amount of bleeding within 24 h post-surgery was evaluated using a bolster gauze.
RESULTS: There was no significant difference in intraoperative bleeding between the intervention (1.54 ± 0.71) and control nostrils (1.69 ± 0.55) with p = 0.172. The amount of bleeding in the postoperative period was significantly reduced in the intervention nostril (1.33 ± 0.55) compared to the control nostril saline (1.81 ± 0.48) with p = 0.001.
CONCLUSIONS: We found that the nasal packing soaked in TXA reduced intraoperative and immediate postoperative bleeding. It is a safe, efficacious and cost-effective alternative to Moffett's solution during FESS and also an alternative to normal saline post-surgery among patients with CRSwNP.
TRIAL REGISTRATION NUMBER: FF-2015-232, 2015.
OBJECTIVES: The primary aim of this review was to investigate the effect of fibrinogen concentrate in postoperative blood loss in adult surgical patients.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Databases of MEDLINE, EMBASE and CENTRAL were searched from their start date until July 2019.
ELIGIBILITY CRITERIA: All randomized clinical trials comparing intravenous fibrinogen concentrate and placebo in adult surgical patients were included, regardless of type of surgery. Observational studies, case reports, case series and non-systematic reviews were excluded.
RESULTS: Thirteen trials (n = 900) were included in this review. In comparison to placebo, fibrinogen concentrate significantly reduced the first 12-hour postoperative blood loss, with a mean difference of -134.6 ml (95% CI -181.9 to -87.4). It also significantly increased clot firmness in thromboelastometry (FIBTEM) with a mean difference of 2.5 mm (95%CI 1.1 to 3.8). No significant differences were demonstrated in the adverse events associated with fibrinogen concentrate use, namely incidence of thromboembolism, myocardial infarction and acute kidney injury.
CONCLUSIONS: In this meta-analysis of 13 randomized trials, low level of evidence and substantial heterogeneity with small sample size limit strong recommendation on the use of fibrinogen concentrate in adult surgical patients. However, its use is tolerable without any notable adverse events.
TRIAL REGISTRATION: CRD42019149164.
OBJECTIVES: To assess the effects of interventions for treating different types of post-extraction bleeding.
SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 24 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 12), MEDLINE Ovid (1946 to 24 January 2018), Embase Ovid (1 May 2015 to 24 January 2018) and CINAHL EBSCO (1937 to 24 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. We searched the reference lists of relevant systematic reviews.
SELECTION CRITERIA: We considered randomised controlled trials (RCTs) that evaluated any intervention for treating PEB, with male or female participants of any age, regardless of type of teeth (anterior or posterior, mandibular or maxillary). Trials could compare one type of intervention with another, with placebo, or with no treatment.
DATA COLLECTION AND ANALYSIS: Three pairs of review authors independently screened search records. We obtained full papers for potentially relevant trials. If data had been extracted, we would have followed the methods described in the Cochrane Handbook for Systematic Reviews of Interventions for the statistical analysis.
MAIN RESULTS: We did not find any randomised controlled trial suitable for inclusion in this review.
AUTHORS' CONCLUSIONS: We were unable to identify any reports of randomised controlled trials that evaluated the effects of different interventions for the treatment of post-extraction bleeding. In view of the lack of reliable evidence on this topic, clinicians must use their clinical experience to determine the most appropriate means of treating this condition, depending on patient-related factors. There is a need for well designed and appropriately conducted clinical trials on this topic, which conform to the CONSORT statement (www.consort-statement.org/).
OBJECTIVE: To compare the outcomes of minimal invasive surgery (MIS) and conventional open surgery for spinal metastasis patients.
SUMMARY OF BACKGROUND DATA: There is lack of knowledge on whether MIS is comparable to conventional open surgery in treating spinal metastasis.
METHODS: Patients with spinal metastasis requiring surgery from January 2008 to December 2010 in two spine centers were recruited. The demographic, preoperative, operative, perioperative and postoperative data were collected and analyzed. Thirty MIS patients were matched with 30 open surgery patients using propensity score matching technique with a match tolerance of 0.02 based on the covariate age, tumor type, Tokuhashi score, and Tomita score.
RESULTS: Both groups had significant improvements in Eastern Cooperative Oncology Group (ECOG), Karnofsky scores, visual analogue scale (VAS) for pain and neurological status postoperatively. However, the difference comparing the MIS and open surgery group was not statistically significant. MIS group had significantly longer instrumented segments (5.5 ± 3.1) compared with open group (3.8 ± 1.7). Open group had significantly longer decompressed segment (1.8 ± 0.8) than MIS group (1.0 ± 1.0). Open group had significantly more blood loss (2062.1 ± 1148.0 mL) compared with MIS group (1156.0 ± 572.3 mL). More patients in the open group (76.7%) needed blood transfusions (with higher average units of blood transfused) compared with MIS group (40.0%). Fluoroscopy time was significantly longer in MIS group (116.1 ± 63.3 s) compared with open group (69.9 ± 42.6 s). Open group required longer hospitalization (21.1 ± 10.8 days) compared with MIS group (11.0 ± 5.0 days).
CONCLUSION: This study demonstrated that MIS resulted in comparable outcome to open surgery for patients with spinal metastasis but has the advantage of less blood loss, blood transfusions, and shorter hospital stay.
LEVEL OF EVIDENCE: 3.
METHODS: A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied.
RESULTS: A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes.
CONCLUSION: Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.).
DATA SOURCES: EMBASE, MEDLINE, CENTRAL, and ISI Web of Science were systematically searched from their inception until May 31, 2019.
REVIEW METHODS: Parallel-arm randomized controlled trials were included.
RESULTS: Seventy-one trials (7539 participants: orthopedics 5450 vs nonorthopedics 1909) were included for quantitative meta-analysis. In comparison to placebo, topical TXA significantly reduced intraoperative blood loss [mean difference (MD) -36.83 mL, 95% confidence interval (CI) -54.77 to -18.88, P < 0.001], total blood loss (MD -319.55 mL, 95% CI -387.42 to -251.69, P < 0.001), and incidence of blood transfusion [odds ratio (OR) 0.30, 95% CI 0.26-0.34, P < 0.001]. Patients who received topical TXA were associated with a shorter length of hospital stay (MD -0.28 days, 95% CI -0.47 to -0.08, P = 0.006). No adverse events associated with the use of topical TXA were observed, namely mortality (OR 0.78, 95% CI 0.45-1.36, P = 0.39), pulmonary embolism (OR 0.73, 95% CI 0.27-1.93, P = 0.52), deep vein thrombosis (OR 1.07, 95% CI 0.65-1.77, P = 0.79), myocardial infarction (OR 0.79, 95% CI 0.21-2.99, P = 0.73), and stroke (OR 0.85, 95% CI 0.28-2.57, P = 0.77). Of all included studies, the risk of bias assessment was "low" for 20 studies, "unclear" for 26 studies and "high" for 25 studies.
CONCLUSIONS: In the meta-analysis of 71 trials (7539 patients), topical TXA reduced the incidence of blood transfusion without any notable adverse events associated with TXA in adults undergoing surgery.
PROSPERO: CRD 42018111762.
METHODS: A retrospective review of CAT patients undergoing bariatric surgery at an academic center from 2008 to 2015 was studied.
RESULTS: A total of 153 patients on CAT underwent surgery [Roux-en-Y gastric bypass (n = 79), sleeve gastrectomy (n = 63), and adjustable gastric banding (n = 11)] during the study period: 85 patients (55%) were females; median age was 56 years (interquartile range [IQR] 49-64), and median BMI was 49 kg/m2 (IQR 43-56). The most common indications for CAT were venous thromboembolism (n = 87) and atrial fibrillation (n = 83). Median duration of procedure and estimated intraoperative blood loss was 150 min (IQR 118-177) and 50 ml (IQR 25-75), respectively. Thirty-day postoperative complications were reported in 33 patients (21.6%) including postoperative bleeding (n = 19), anastomotic leak (n = 3), and pulmonary embolism (n = 1). Nineteen patients (12%) with early postoperative bleeding were further categorized to intra-abdominal (n = 10), intraluminal (n = 6), and at the port site or abdominal wall (n = 3). All-cause readmissions within 30 days of surgery occurred in 19 patients (12%). There was no 30-day mortality.
CONCLUSION: In our experience, patients who require chronic anticoagulation medication are higher than average risk for postoperative complications and all-cause readmission rates. Careful surgical technique and close attention to postoperative anticoagulation protocols are essential to decrease perioperative risk in this high-risk cohort.
METHODS: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding.
RESULTS: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001).
CONCLUSION: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a standard thromboprophylactic agent.
Methods and results: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure.
Conclusion: The outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.
METHODS: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30 days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding.
RESULTS: Of 10 010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13·7 per cent of patients having aneurysm repair allocated to aspirin and 9·0 per cent who had placebo (hazard ratio (HR) 1·48, 95 per cent c.i. 0·71 to 3·09). Among patients who had surgery for occlusive vascular disease, 15·8 per cent allocated to aspirin and 13·6 per cent on placebo had the primary outcome (HR 1·16, 0·62 to 2·17). There was no interaction with the primary outcome for type of surgery (P = 0·294) or aspirin stratum (P = 0·623). There was no interaction for vascular occlusive complications (P = 0·413) or bleeding (P = 0·900) for vascular compared with non-vascular surgery.
CONCLUSION: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications. Registration number: NCT01082874 ( http://www.clinicaltrials.gov).