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Neuroradiology Apr 2016Treatment of complex anterior circulation aneurysms with flow diverters (FDs) has become common practice in neurovascular centers. However, this treatment method for... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Treatment of complex anterior circulation aneurysms with flow diverters (FDs) has become common practice in neurovascular centers. However, this treatment method for posterior circulation aneurysms (PCAs) still remains controversial.
METHODS
Through searches for reports on the treatment of PCAs with FDs, we conducted a systematic review of the literature on its clinical efficacy and safety using random-effect binomial meta-analysis.
RESULTS
We included 14 studies, which reported on a total of 225 PCAs in 220 patients. Procedure-related good outcome rate was 79% (95% confidence interval (CI), 72-84), with significantly lower odds among patients with ruptured aneurysms and basilar artery aneurysms. Procedure-related mortality rate was 15% (95% CI 10-21), with significantly higher rates among patients with giant aneurysms and basilar artery aneurysms. The rate of complete aneurysm occlusion at 6-month digital subtraction angiography (DSA) was 84%. Ischemic stroke rate was 11%. Perforator infarction rate was 7%. Postoperative subarachnoid hemorrhage (SAH) rate was 3%. Intraparenchymal hemorrhage (IPH) rate was 4%.
CONCLUSIONS
Flow diverter treatment of PCAs is an effective method, which provides a high rate of complete occlusion at 6-month DSA. However, compared with anterior circulation aneurysms, patients with PCAs are at significantly higher risk of mortality, ischemic stroke and perforator infarction. Our findings indicate that, in most clinical centers, flow diverter treatment of PCAs should be conducted in carefully selected patients with poor natural history and no optimal treatment strategy. For ruptured and giant basilar artery aneurysms, there is still no good treatment option.
Topics: Blood Vessel Prosthesis; Endovascular Procedures; Humans; Intracranial Aneurysm; Stents
PubMed: 26801480
DOI: 10.1007/s00234-016-1649-2 -
Healthcare (Basel, Switzerland) Dec 2022Dental procedures have posed challenges in managing anticoagulated patients due to early reports of oral hemorrhage. This study aims to evaluate the risks of... (Review)
Review
Dental procedures have posed challenges in managing anticoagulated patients due to early reports of oral hemorrhage. This study aims to evaluate the risks of postoperative bleeding with the local application of tranexamic acid. A systematic search was conducted until 31 March 2022, with keywords including tranexamic acid, oral hemorrhage, dental, and/or coagulation. The following databases were searched: PubMed, Scopus, Web of Science, CINAHL Plus, and Cochrane Library. Statistical analysis was conducted using Review Manager 5.4. In total, 430 patients were pooled in with the local application of tranexamic acid using mouthwash, irrigation, and compression with a gauze/gauze pad. The mean age was 61.8 years in the intervention group and 58.7 in the control group. Only 4 patients in the intervened group out of the 210 discontinued the trial due to non-drug-related adverse events. The risk difference was computed as -0.07 ( = 0.05), meaning that patients administered with local antifibrinolytic therapy for postoperative bleeding reduction for dental procedures were at a 7% less risk of oral bleeding. Current evidence on managing anticoagulated patients undergoing dental or oral procedures remains unclear. The present study presents favorable outcomes of postoperative bleeding with local tranexamic acid used in the postoperative period.
PubMed: 36554047
DOI: 10.3390/healthcare10122523 -
Fibrin and Thrombin Sealants in Vascular and Cardiac Surgery: A Systematic Review and Meta-analysis.European Journal of Vascular and... Sep 2020In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery.
DATA SOURCES
Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019.
REVIEW METHODS
Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model.
RESULTS
Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data.
CONCLUSION
The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.
Topics: Blood Loss, Surgical; Cardiac Surgical Procedures; Fibrin Tissue Adhesive; Hemostasis; Hemostatics; Humans; Postoperative Hemorrhage; Risk Factors; Thrombin; Time Factors; Tissue Adhesives; Treatment Outcome; Vascular Surgical Procedures
PubMed: 32620348
DOI: 10.1016/j.ejvs.2020.05.016 -
The Cochrane Database of Systematic... Mar 2023Acute primary angle closure (APAC) is a potentially blinding condition. It is one of the few ophthalmic emergencies and carries high rates of visual morbidity in the... (Review)
Review
BACKGROUND
Acute primary angle closure (APAC) is a potentially blinding condition. It is one of the few ophthalmic emergencies and carries high rates of visual morbidity in the absence of timely intervention. Laser peripheral iridotomy (LPI) has been the standard of care thus far. However, LPI does not eliminate the long-term risk of chronic angle closure glaucoma and other associated sequelae. There has been increasing interest in lens extraction as the primary treatment for the spectrum of primary angle closure disease, and it is as yet unclear whether these results can be extrapolated to APAC, and whether lens extraction provides better long-term outcomes. We therefore sought to evaluate the effectiveness of lens extraction in APAC to help inform the decision-making process. OBJECTIVES: To assess the effect of lens extraction compared to LPI in the treatment of APAC.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 1), Ovid MEDLINE, Ovid MEDLINE E-pub Ahead of Print, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily (January 1946 to 10 January 2022), Embase (January 1947 to 10 January 2022), PubMed (1946 to 10 January 2022), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to 10 January 2022), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 10 January 2022.
SELECTION CRITERIA
We included randomized controlled clinical trials comparing lens extraction against LPI in adult participants ( ≥ 35 years) with APAC in one or both eyes.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology and assessed the certainty of the body of evidence for prespecified outcomes using the GRADE approach.
MAIN RESULTS
We included two studies conducted in Hong Kong and Singapore, comprising 99 eyes (99 participants) of predominantly Chinese origin. The two studies compared LPI with phacoemulsification performed by experienced surgeons. We assessed that both studies were at high risk of bias. There were no studies evaluating other types of lens extraction procedures. Phacoemulsification may result in an increased proportion of participants with intraocular pressure (IOP) control compared with LPI at 18 to 24 months (risk ratio (RR) 1.66, 95% confidence interval (CI) 1.28 to 2.15; 2 studies, n = 97; low certainty evidence) and may reduce the need for further IOP-lowering surgery within 24 months (RR 0.07, 96% CI 0.01 to 0.51; 2 studies, n = 99; very low certainty evidence). Phacoemulsification may result in a lower mean IOP at 12 months compared to LPI (mean difference (MD) -3.20, 95% CI -4.79 to -1.61; 1 study, n = 62; low certainty evidence) and a slightly lower mean number of IOP-lowering medications at 18 months (MD -0.87, 95% CI -1.28 to -0.46; 1 study, n = 60; low certainty evidence), but this may not be clinically significant. Phacoemulsification may have little to no effect on the proportion of participants with one or more recurrent APAC episodes in the same eye (RR 0.32, 95% CI 0.01 to 7.30; 1 study, n = 37; very low certainty evidence). Phacoemulsification may result in a wider iridocorneal angle assessed by Shaffer grading at six months (MD 1.15, 95% CI 0.83 to 1.47; 1 study, n = 62; very low certainty evidence). Phacoemulsification may have little to no effect on logMAR best-corrected visual acuity (BCVA) at six months (MD -0.09, 95% CI -0.20 to 0.02; 2 studies, n = 94; very low certainty evidence). There was no evidence of a difference in the extent of peripheral anterior synechiae (PAS) (clock hours) between intervention arms at 6 months (MD -1.86, 95% CI -7.03 to 3.32; 2 studies, n = 94; very low certainty evidence), although the phacoemulsification group may have less PAS (degrees) at 12 months (MD -94.20, 95% CI -140.37 to -48.03; 1 study, n = 62) and 18 months (MD -127.30, 95% CI -168.91 to -85.69; 1 study, n = 60). In one study, there were 26 adverse events in the phacoemulsification group: intraoperative corneal edema (n = 12), posterior capsular rupture (n = 1), intraoperative bleeding from iris root (n = 1), postoperative fibrinous anterior chamber reaction (n = 7), and visually significant posterior capsular opacification (n = 5), and no cases of suprachoroidal hemorrhage or endophthalmitis. There were four adverse events in the LPI group: closed iridotomy (n = 1) and small iridotomies that required supplementary laser (n = 3). In the other study, there was one adverse event in the phacoemulsification group (IOP > 30 mmHg on day 1 postoperatively (n = 1)), and no intraoperative complications. There were five adverse events in the LPI group: transient hemorrhage (n = 1), corneal burn (n = 1), and repeated LPI because of non-patency (n = 3). Neither study reported health- or vision-related quality of life measures.
AUTHORS' CONCLUSIONS
Low certainty evidence suggests that early lens extraction may produce more favorable outcomes compared to initial LPI in terms of IOP control. Evidence for other outcomes is less clear. Future high-quality and longer-term studies evaluating the effects of either intervention on the development of glaucomatous damage and visual field changes as well as health-related quality of life measures would be helpful.
Topics: Adult; Humans; Cataract Extraction; Glaucoma; Intraocular Pressure; Phacoemulsification; Quality of Life
PubMed: 36884304
DOI: 10.1002/14651858.CD015116.pub2 -
World Journal of Surgery Dec 2023The presence of an aberrant right hepatic artery (a-RHA) could influence the oncological and postoperative results after pancreaticoduodenectomy (PD). (Meta-Analysis)
Meta-Analysis Review
The Presence of an Aberrant Right Hepatic Artery Did Not Influence Surgical and Oncological Outcomes After Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-Analysis.
BACKGROUND
The presence of an aberrant right hepatic artery (a-RHA) could influence the oncological and postoperative results after pancreaticoduodenectomy (PD).
METHODS
A systematic review and metanalysis were conducted, including all comparative studies having patients who underwent PD without (na-RHA) or with a-RHA. The results were reported as risk ratios (RRs), mean differences (MDs), or hazard ratios (HRs) with 95% confidence intervals (95 CI). The random effects model was used to calculate the effect sizes. The endpoints were distinguished as critical and important. Critical endpoints were: R1 resection, overall survival (OS), morbidity, mortality, and biliary fistula (BL). Important endpoints were: postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post pancreatectomy hemorrhage (PPH), length of stay (LOS), and operative time (OT).
RESULTS
Considering the R1 rate no significant differences were observed between the two groups (RR 1.06; 0.89 to 1.27). The two groups have a similar OS (HR 0.95; 0.85 to 1.06). Postoperative morbidity and mortality were similar between the two groups, with a RR of 0.97 (0.88 to 1.06) and 0.81 (0.54 to 1.20), respectively. The biliary fistula rate was similar between the two groups (RR of 1.09; 0.72 to 1.66). No differences were observed for non-critical endpoints.
CONCLUSION
The presence of a-RHA does not affect negatively the short-term and long-term clinical outcomes of PD.
Topics: Humans; Pancreaticoduodenectomy; Pancreatectomy; Biliary Fistula; Hepatic Artery; Pancreas; Pancreatic Fistula; Postoperative Complications
PubMed: 37816977
DOI: 10.1007/s00268-023-07191-2 -
The Cochrane Database of Systematic... Feb 2020Neovascular glaucoma (NVG) is a potentially blinding, secondary glaucoma. It is caused by the formation of abnormal new blood vessels, which prevent normal drainage of... (Review)
Review
BACKGROUND
Neovascular glaucoma (NVG) is a potentially blinding, secondary glaucoma. It is caused by the formation of abnormal new blood vessels, which prevent normal drainage of aqueous from the anterior segment of the eye. Anti-vascular endothelial growth factor (anti-VEGF) medications are specific inhibitors of the primary mediators of neovascularization. Studies have reported the effectiveness of anti-VEGF medications for the control of intraocular pressure (IOP) in NVG.
OBJECTIVES
To assess the effectiveness of intraocular anti-VEGF medications, alone or with one or more type of conventional therapy, compared with no anti-VEGF medications for the treatment of NVG.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register); MEDLINE; Embase; PubMed; and LILACS to 22 March 2019; metaRegister of Controlled Trials to 13 August 2013; and two additional trial registers to 22 March 2019. We did not use any date or language restrictions in the electronic search for trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of people treated with anti-VEGF medications for NVG.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the search results for trials, extracted data, and assessed risk of bias, and the certainty of the evidence. We resolved discrepancies through discussion.
MAIN RESULTS
We included four RCTs (263 participants) and identified one ongoing RCT. Each trial was conducted in a different country: China, Brazil, Egypt, and Japan. We assessed the trials to have an unclear risk of bias for most domains due to insufficient information. Two trials compared intravitreal bevacizumab combined with Ahmed valve implantation and panretinal photocoagulation (PRP) with Ahmed valve implantation and PRP. We did not combine these two trials due to substantial clinical and statistical heterogeneity. One trial randomised participants to receive an injection of either an intravitreal anti-VEGF medication or placebo at the first visit, followed by non-randomised treatment according to clinical findings after one week. The last trial randomised participants to PRP with and without ranibizumab, but details of the study were unavailable for further analysis. Two trials that examined IOP showed inconsistent results. One found inconclusive results for mean IOP between participants who received anti-VEGF medications and those who did not, at one month (mean difference [MD] -1.60 mmHg, 95% confidence interval [CI] -4.98 to 1.78; 40 participants), and at one year (MD 1.40 mmHg, 95% CI -4.04 to 6.84; 30 participants). Sixty-five percent of the participants with anti-VEGF medications achieved IOP ≤ 21 mmHg, versus 60% without anti-VEGF medications. In another trial, those who received anti-VEGF medications were more likely to reduce their IOP than those who did not receive them, at one month (MD -6.50 mmHg, 95% CI -7.93 to -5.07; 40 participants), and at one year (MD -12.00 mmHg, 95% CI -16.79 to -7.21; 40 participants). Ninety-five percent of the participants with anti-VEGF medications achieved IOP ≤ 21 mmHg, versus 50% without anti-VEGF medications. The certainty of a body of evidence was low for this outcome due to limitations in the design and inconsistency of results between studies. Post-operative complications included anterior chamber bleeding (3 eyes) and conjunctival hemorrhage (2 participants) in the anti-VEGF medications group, and retinal detachment and phthisis bulbi (1 participant each) in the control group. The certainty of evidence is low due to imprecision of results and indirectness of evidence. No trial reported the proportion of participants with improvement in visual acuity, proportion of participants with complete regression of new iris vessels, or the proportion of participants with relief of pain and resolution of redness at four- to six-week, or one-year follow-up.
AUTHORS' CONCLUSIONS
Currently available evidence is uncertain regarding the long-term effectiveness of anti-VEGF medications, such as intravitreal ranibizumab or bevacizumab or aflibercept, as an adjunct to conventional treatment in lowering IOP in NVG. More research is needed to investigate the long-term effect of these medications compared with, or in addition to, conventional surgical or medical treatment in lowering IOP in NVG.
Topics: Endothelial Growth Factors; Glaucoma, Neovascular; Humans; Intraocular Pressure; Randomized Controlled Trials as Topic; Vascular Endothelial Growth Factor A; Visual Acuity
PubMed: 32027392
DOI: 10.1002/14651858.CD007920.pub3 -
European Journal of Vascular and... Nov 2022Establishing the predictive value of neck characteristics and real achieved sealing zone is essential to foster risk stratified procedure selection and imaging... (Meta-Analysis)
Meta-Analysis Review
Pre-operative Aortic Neck Characteristics and Post-operative Sealing Zone as Predictors of Type 1a Endoleak and Migration After Endovascular Aneurysm Repair: A Systematic Review and Meta-Analysis.
OBJECTIVE
Establishing the predictive value of neck characteristics and real achieved sealing zone is essential to foster risk stratified procedure selection and imaging surveillance. This systematic review provides an overview of pre-operative aortic neck characteristics and post-operative real achieved sealing zone and their respective risk of type 1a endoleak and migration after endovascular aneurysm repair (EVAR).
METHODS
In agreement with PRISMA guidelines, MEDLINE, Embase, and Cochrane CENTRAL were searched. Data on neck characteristics, sealing zone, and EVAR outcome were extracted. Meta-analyses were performed to investigate the effect of neck diameter, angulation, and shape on type 1a endoleak (total, early ≤ 90 days, and late > 90 days) and migration in patients who underwent EVAR. A qualitative summary was also provided.
RESULTS
Thirty-three studies were included. Patients with a larger neck diameter had an increased risk of total type 1a endoleak (nine studies: OR 3.32, 95% CI 2.38 - 4.63), early type 1a endoleak (six studies: OR 2.64, 95% CI 1.27 - 5.48), late type 1a endoleak (six studies: OR 3.26, 95% CI 2.12 - 5.03), and migration (seven studies: OR 2.88, 95% CI 1.32 - 6.26). An angulated neck increased the risk of total type 1a endoleak (seven studies: OR 4.27, 95% CI 1.55 - 11.78) and late type 1a endoleak (seven studies: OR 5.56, 95% CI 2.19 - 14.13). Neck shape was not associated with type 1a endoleak. Neck length and real achieved sealing zone on post-EVAR computed tomography were identified as risk factors for type 1a endoleak and migration through qualitative summary.
CONCLUSION
There seems to be some consistent evidence that aortic neck diameter, angulation, and length are associated with the development of type 1a endoleak or migration. Real achieved sealing zone might be an important addition during follow up. However, a small number of studies, with serious limitations, could be included, and there was considerable variability in reporting patients and outcomes. A proposal for standardisation of aortic and EVAR data in future studies is provided.
Topics: Humans; Endoleak; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Blood Vessel Prosthesis; Endovascular Procedures; Retrospective Studies; Treatment Outcome; Time Factors; Risk Factors
PubMed: 35988861
DOI: 10.1016/j.ejvs.2022.08.017 -
The Cochrane Database of Systematic... Sep 2016Pancreatic cancer remains one of the five leading causes of cancer deaths in industrialized nations. For adenocarcinomas in the head of the gland and premalignant... (Review)
Review
BACKGROUND
Pancreatic cancer remains one of the five leading causes of cancer deaths in industrialized nations. For adenocarcinomas in the head of the gland and premalignant lesions, partial pancreaticoduodenectomy represents the standard treatment for resectable tumours. The gastro- or duodenojejunostomy after partial pancreaticoduodenectomy can be reestablished via either an antecolic or a retrocolic route. The debate about the more favourable technique for bowel reconstruction is ongoing.
OBJECTIVES
To compare the effectiveness and safety of antecolic and retrocolic gastro- or duodenojejunostomy after partial pancreaticoduodenectomy.
SEARCH METHODS
We conducted a systematic literature search on 29 September 2015 to identify all randomised controlled trials in the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library 2015, issue 9, MEDLINE (1946 to September 2015), and EMBASE (1974 to September 2015). We applied no language restrictions. We handsearched reference lists of identified trials to identify further relevant trials, and searched the trial registry clinicaltrials.gov for ongoing trials.
SELECTION CRITERIA
We considered all randomised controlled trials that compared antecolic versus retrocolic reconstruction of bowel continuity after partial pancreaticoduodenectomy for any given indication to be eligible.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the identified references and extracted data from the included trials. The same two review authors independently assessed risk of bias of included trials, according to standard Cochrane methodology. We used a random-effects model to pool the results of the individual trials in a meta-analysis. We used odds ratios to compare binary outcomes and mean differences for continuous outcomes.
MAIN RESULTS
Of a total of 216 citations identified by the systematic literature search, we included six randomised controlled trials (reported in nine publications), with a total of 576 participants. We identified a moderate heterogeneity of methodological quality and risk of bias of the included trials. None of the pooled results for our main outcomes of interest showed significant differences: delayed gastric emptying (OR 0.60; 95% CI 0.31 to 1.18; P = 0.14), mortality (RD -0.01; 95% CI -0.03 to 0.02; P = 0.72), postoperative pancreatic fistula (OR 0.98; 95% CI 0.65 to 1.47; P = 0.92), postoperative haemorrhage (OR 0.79; 95% CI 0.38 to 1.65; P = 0.53), intra-abdominal abscess (OR 0.93; 95% CI 0.52 to 1.67; P = 0.82), bile leakage (OR 0.89; 95% CI 0.36 to 2.15; P = 0.79), reoperation rate (OR 0.59; 95% CI 0.27 to 1.31; P = 0.20), and length of hospital stay (MD -0.67; 95%CI -2.85 to 1.51; P = 0.55). Furthermore, the perioperative outcomes duration of operation, intraoperative blood loss and time to NGT removal showed no relevant differences. Only one trial reported quality of life, on a subgroup of participants, also without a significant difference between the two groups at any time point. The overall quality of the evidence was only low to moderate, due to heterogeneity, some inconsistency and risk of bias in the included trials.
AUTHORS' CONCLUSIONS
There was low to moderate quality evidence suggesting no significant differences in morbidity, mortality, length of hospital stay, or quality of life between antecolic and retrocolic reconstruction routes for gastro- or duodenojejunostomy. Due to heterogeneity in definitions of the endpoints between trials, and differences in postoperative management, future research should be based on clearly defined endpoints and standardised perioperative management, to potentially elucidate differences between these two procedures. Novel strategies should be evaluated for prophylaxis and treatment of common complications, such as delayed gastric emptying.
PubMed: 27689801
DOI: 10.1002/14651858.CD011862.pub2 -
Medicine Aug 2016A meta-analysis concerning perioperative coagulation competence, hemorrhage, and outcome was conducted including the use of hydroxyethyl starches (HESs), dextran, or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A meta-analysis concerning perioperative coagulation competence, hemorrhage, and outcome was conducted including the use of hydroxyethyl starches (HESs), dextran, or albumin versus administration of a crystalloid as control to assess the efficacy and safety of colloids and crystalloids for fluid administration during major elective surgery. Surgery was restricted to cardiovascular and noncardiovascular surgery, and HESs were stratified to HES 130/0.4 and HES 200/0.5.
METHODS
We searched Cochrane Central Register of Controlled Trials, MEDLINE, ISI Web of Science, EMBASE, conference proceedings, reference lists, and databases of ongoing trials.
RESULTS
Thirty one primary clinical randomized controlled trials included 2287 patients undergoing major surgery from January 2000 to August 2015. The perioperative changes in coagulation competence were measured by thromboelastography (TEG) maximum amplitude (MA) in 9 studies administering crystalloids versus HES and in 4 studies administering albumin versus HES. All studies but 1 disclosed increased reduction in TEG-MA following HES administration (P = 0.0001 and 0.0002). The total loss of blood was reported in 17 studies in which crystalloids were compared to HES and 12 studies reported increased blood loss after administration of HES (P < 0.003). When administering albumin versus HES, 6 studies reported reduced hemorrhage associated with albumin administration (P = 0.005). Reoperation was not significantly reduced by the use of crystalloids, but may be more frequent after HESs compared to albumin (P < 0.03). In this analysis, more patients admitted to administration of HESs were exposed to decrease coagulation competence, compared to perioperative crystalloids and albumin administration.
CONCLUSION
This stratified meta-analysis showed that increased blood loss was found in noncardiovascular surgery among patients receiving HES compared with crystalloids, followed by a marked reduction in TEG-MA, and infusion of 3rd-generation HES products did not influence the results significantly.
Topics: Albumins; Blood Loss, Surgical; Crystalloid Solutions; Dextrans; Humans; Hydroxyethyl Starch Derivatives; Isotonic Solutions; Perioperative Care; Plasma Substitutes; Postoperative Hemorrhage; Thrombelastography
PubMed: 27495098
DOI: 10.1097/MD.0000000000004498 -
The Cochrane Database of Systematic... Mar 2023Neonates may undergo surgery because of malformations such as diaphragmatic hernia, gastroschisis, congenital heart disease, and hypertrophic pyloric stenosis, or... (Review)
Review
BACKGROUND
Neonates may undergo surgery because of malformations such as diaphragmatic hernia, gastroschisis, congenital heart disease, and hypertrophic pyloric stenosis, or complications of prematurity, such as necrotizing enterocolitis, spontaneous intestinal perforation, and retinopathy of prematurity that require surgical treatment. Options for treatment of postoperative pain include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported. The assessment of the effects of opioids is of utmost importance, especially for neonates in substantial pain during the postoperative period.
OBJECTIVES
To evaluate the benefits and harms of systemic opioid analgesics in neonates who underwent surgery on all-cause mortality, pain, and significant neurodevelopmental disability compared to no intervention, placebo, non-pharmacological interventions, different types of opioids, or other drugs.
SEARCH METHODS
We searched Cochrane CENTRAL, MEDLINE via PubMed and CINAHL in May 2021. We searched the WHO ICTRP, clinicaltrials.gov, and ICTRP trial registries. We searched conference proceedings, and the reference lists of retrieved articles for RCTs and quasi-RCTs. SELECTION CRITERIA: We included randomized controlled trials (RCTs) conducted in preterm and term infants of a postmenstrual age up to 46 weeks and 0 days with postoperative pain where systemic opioids were compared to 1) placebo or no intervention; 2) non-pharmacological interventions; 3) different types of opioids; or 4) other drugs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods, all-cause mortality during initial hospitalization, major neurodevelopmental disability, and cognitive and educational outcomes in children more than five years old. We used the fixed-effect model with risk ratio (RR) and risk difference (RD) for dichotomous data and mean difference (MD) for continuous data. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We included four RCTs enrolling 331 infants in four countries across different continents. Most studies considered patients undergoing large or medium surgical procedures (including major thoracic or abdominal surgery), who potentially required pain control through opioid administration after surgery. The randomized trials did not consider patients undergoing minor surgery (including inguinal hernia repair) and those individuals exposed to opioids before the beginning of the trial. Two RCTs compared opioids with placebo; one fentanyl with tramadol; and one morphine with paracetamol. No meta-analyses could be performed because the included RCTs reported no more than three outcomes within the prespecified comparisons. Certainty of the evidence was very low for all outcomes due to imprecision of the estimates (downgrade by two levels) and study limitations (downgrade by one level). Comparison 1: opioids versus no treatment or placebo Two trials were included in this comparison, comparing either tramadol or tapentadol with placebo. No data were reported on the following critical outcomes: pain; major neurodevelopmental disability; or cognitive and educational outcomes in children more than five years old. The evidence is very uncertain about the effect of tramadol compared with placebo on all-cause mortality during initial hospitalization (RR 0.32, 95% Confidence Interval (CI) 0.01 to 7.70; RD -0.03, 95% CI -0.10 to 0.05, 71 participants, 1 study; I² = not applicable). No data were reported on: retinopathy of prematurity; or intraventricular hemorrhage. Comparison 2: opioids versus non-pharmacological interventions No trials were included in this comparison. Comparison 3: head-to-head comparisons of different opioids One trial comparing fentanyl with tramadol was included in this comparison. No data were reported on the following critical outcomes: pain; major neurodevelopmental disability; or cognitive and educational outcomes in children more than five years old. The evidence is very uncertain about the effect of fentanyl compared with tramadol on all-cause mortality during initial hospitalization (RR 0.99, 95% CI 0.59 to 1.64; RD 0.00, 95% CI -0.13 to 0.13, 171 participants, 1 study; I² = not applicable). No data were reported on: retinopathy of prematurity; or intraventricular hemorrhage. Comparison 4: opioids versus other analgesics and sedatives One trial comparing morphine with paracetamol was included in this comparison. The evidence is very uncertain about the effect of morphine compared with paracetamol on COMFORT pain scores (MD 0.10, 95% CI -0.85 to 1.05; 71 participants, 1 study; I² = not applicable). No data were reported on the other critical outcomes, i.e. major neurodevelopmental disability; cognitive and educational outcomes in children more than five years old, all-cause mortality during initial hospitalization; retinopathy of prematurity; or intraventricular hemorrhage.
AUTHORS' CONCLUSIONS
Limited evidence is available on opioid administration for postoperative pain in newborn infants compared to either placebo, other opioids, or paracetamol. We are uncertain whether tramadol reduces mortality compared to placebo; none of the studies reported pain scores, major neurodevelopmental disability, cognitive and educational outcomes in children older than five years old, retinopathy of prematurity, or intraventricular hemorrhage. We are uncertain whether fentanyl reduces mortality compared to tramadol; none of the studies reported pain scores, major neurodevelopmental disability, cognitive and educational outcomes in children older than five years old, retinopathy of prematurity, or intraventricular hemorrhage. We are uncertain whether morphine reduces pain compared to paracetamol; none of the studies reported major neurodevelopmental disability, cognitive and educational outcomes in children more than five years old, all-cause mortality during initial hospitalization, retinopathy of prematurity, or intraventricular hemorrhage. We identified no studies comparing opioids versus non-pharmacological interventions.
Topics: Child; Infant; Humans; Infant, Newborn; Child, Preschool; Analgesics, Opioid; Tramadol; Acetaminophen; Retinopathy of Prematurity; Analgesics; Fentanyl; Morphine; Pain, Postoperative; Cerebral Hemorrhage
PubMed: 36870076
DOI: 10.1002/14651858.CD014876.pub2