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PloS One 2014To assess biodegradable nasal packing effectiveness for improving postoperative symptoms and mucosal healing after endoscopic sinonasal surgery as compared with... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To assess biodegradable nasal packing effectiveness for improving postoperative symptoms and mucosal healing after endoscopic sinonasal surgery as compared with conventional/non-packing groups.
METHODS
Relevant articles were searched on PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. We included randomized controlled trials (RCTs) that compared biodegradable packings with conventional packings or no packing, reporting postoperative symptoms and/or mucosal healing outcomes.
RESULTS
This review included 19 studies, of which 11 compared biodegradable packings with conventional packings. Meta-analysis found that biodegradable packings significantly improved postoperative symptoms: bleeding at removal, pain at removal, pain in situ, and nasal blockage. Mucosal healing outcomes were inconsistent within studies, with no data could be pooled. Eight studies compared biodegradable packings with non-packing group. Postoperative symptom data in this comparison could not be pooled: A protective or equal effect on postoperative bleeding was reported in different studies; no difference was reported in pain status and nasal blockage. As for mucosal healing, meta-analysis showed that two arms of comparison had similar effect on synechiae, edema, infection and granulation at each time point.
CONCLUSION
The limiting evidence suggests that biodegradable nasal packings are statistically better than conventional packings in postoperative symptoms, and probably comparable to non-packing group, as in this comparison we could not carry out meta-analysis. No beneficial or detrimental effect on postoperative mucosal healing could be determined based on existing evidence.
Topics: Endoscopy; Humans; Nasal Obstruction; Nasal Surgical Procedures; Paranasal Sinuses; Postoperative Care; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Treatment Outcome; Wound Healing
PubMed: 25526585
DOI: 10.1371/journal.pone.0115458 -
HPB : the Official Journal of the... Sep 2020The role of wrapping in the setting of pancreaticoduodenectomy (PD) is controversial. This study aimed to assess whether the use of omental or falciform ligament... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The role of wrapping in the setting of pancreaticoduodenectomy (PD) is controversial. This study aimed to assess whether the use of omental or falciform ligament wrapping of pancreatic anastomosis and/or vessels could reduce the rate of POPF and postpancreatectomy hemorrhage (PPH) after PD.
METHODS
Studies comparing PD with (PD-W) and without wrapping (PD-nW) were included. Primary outcomes were POPF and extraluminal PPH. Dichotomous variables were analyzed for risk ratios (RR) with 95% Confidence Intervals.
RESULTS
Nine studies involving 4384 patients were considered. The risk of POPF and clinically relevant POPF (CR-POPF) was similar between patients with and without omental wrapping of pancreatic anastomosis when considered as overall. A significant benefit from wrapping in terms of CR-POPF (RR 0.14, P = 0.002) was reported for patients who underwent PD with pancreaticojejunostomy (PJ). The risk of extraluminal PPH was slightly lower in patients who underwent vessels wrapping compared to those who did not (RR 0.58, P = 0.020). Similar extraluminal PPH rates were reported for patients with and without wrapping of pancreatic anastomosis (P = 0.620).
DISCUSSION
Data from low-evidence studies suggest that omental wrapping of PJ may reduce the incidence of CR-POPF, whereas vessels wrapping may have a slight effect for preventing extraluminal PPH.
Topics: Anastomosis, Surgical; Humans; Ligaments; Pancreatic Fistula; Pancreaticoduodenectomy; Pancreaticojejunostomy; Postoperative Complications
PubMed: 32631806
DOI: 10.1016/j.hpb.2020.05.003 -
The Cochrane Database of Systematic... May 2023Vitrectomy is an established treatment for the complications of proliferative diabetic retinopathy (PDR). However, a number of complications can occur during and after... (Review)
Review
BACKGROUND
Vitrectomy is an established treatment for the complications of proliferative diabetic retinopathy (PDR). However, a number of complications can occur during and after vitrectomy for PDR. These include bleeding and the creation of retinal holes during surgery, and bleeding, retinal detachment and scar tissue on the retina after surgery. These complications can limit vision, require further surgery and delay recovery. The use of anti-vascular endothelial growth factor (anti-VEGF) agents injected into the eye before surgery has been proposed to reduce the occurrence of these complications. Anti-VEGF agents can reduce the amount and vascularity of abnormal new vessels associated with PDR, facilitating their dissection during surgery, reducing intra- and postoperative bleeding, and potentially improving outcomes.
OBJECTIVES
To assess the effects of perioperative anti-VEGF use on the outcomes of vitrectomy for the treatment of complications for proliferative diabetic retinopathy (PDR).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 22 June 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that looked at the use of anti-VEGFs and the incidence of complications in people undergoing vitrectomy for PDR. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed and extracted the data. We used the standard methodological procedures expected by Cochrane. The critical outcomes of the review were the mean difference in best corrected visual acuity (BCVA) between study arms at six (± three) months after the primary vitrectomy, the incidence of early postoperative vitreous cavity haemorrhage (POVCH, within four weeks postoperatively), the incidence of late POVCH (occurring more than four weeks postoperatively), the incidence of revision surgery for POVCH within six months, the incidence of revision surgery for recurrent traction/macular pucker of any type and/or rhegmatogenous retinal detachment within six months and vision-related quality of life (VRQOL) measures. Important outcomes included the proportion of people with a visual acuity of counting fingers (1.8 logMAR or worse), the number of operative retinal breaks reported and the frequency of silicone oil tamponade required at time of surgery.
MAIN RESULTS
The current review includes 28 RCTs that looked at the pre- or intraoperative use of intravitreal anti-VEGFs to improve the outcomes of pars plana vitrectomy for complications of PDR. The studies were conducted in a variety of countries (11 from China, three from Iran, two from Italy, two from Mexico and the remaining studies from South Korea, the UK, Egypt, Brazil, Japan, Canada, the USA, Indonesia and Pakistan). The inclusion criteria for entry into the studies were the well-recognised complications of proliferative retinopathy: non-clearing vitreous haemorrhage, tractional retinal detachment involving the macula or combined tractional rhegmatogenous detachment. The included studies randomised a total of 1914 eyes. We identified methodological issues in all of the included studies. Risk of bias was highest for masking of participants and investigators, and a number of studies were unclear when describing randomisation methods and sequence allocation. Participants receiving intravitreal anti-VEGF in addition to pars plana vitrectomy achieved better BCVA at six months compared to people undergoing vitrectomy alone (mean difference (MD) -0.25 logMAR, 95% confidence interval (CI) -0.39 to -0.11; 13 studies, 699 eyes; low-certainty evidence). Pre- or intraoperative anti-VEGF reduced the incidence of early POVCH (12% versus 31%, risk ratio (RR) 0.44, 95% CI 0.34 to 0.58; 14 studies, 1038 eyes; moderate-certainty evidence). Perioperative anti-VEGF use was also associated with a reduction in the incidence of late POVCH (10% versus 23%, RR 0.47, 95% CI 0.30 to 0.74; 11 studies, 579 eyes; high-certainty evidence). The need for revision surgery for POVCH occurred less frequently in the anti-VEGF group compared with control, but the confidence intervals were wide and compatible with no effect (4% versus 13%, RR 0.44, 95% CI 0.15 to 1.28; 4 studies 207 eyes; moderate-certainty evidence). Similar imprecisely measured effects were seen for revision surgery for rhegmatogenous retinal detachment (5% versus 11%, RR 0.50, 95% CI 0.15 to 1.66; 4 studies, 145 eyes; low-certainty evidence). Anti-VEGFs reduce the incidence of intraoperative retinal breaks (12% versus 31%, RR 0.37, 95% CI 0.24 to 0.59; 12 studies, 915 eyes; high-certainty evidence) and the need for silicone oil (19% versus 41%, RR 0.46, 95% CI 0.27 to 0.80; 10 studies, 591 eyes; very low-certainty evidence). No data were available on quality of life outcomes or the proportion of participants with visual acuity of counting fingers or worse.
AUTHORS' CONCLUSIONS
The perioperative use of anti-VEGF reduces the risk of late POVCH, probably results in lower early POVCH risk and may improve visual outcomes. It also reduces the incidence of intraoperative retinal breaks. The evidence is very uncertain about its effect on the need for silicone oil tamponade. The reported complications from its use appear to be low. Agreement on variables included and outcome standardisation is required in trials studying vitrectomy for PDR.
Topics: Humans; Diabetes Mellitus; Diabetic Retinopathy; Endothelial Growth Factors; Postoperative Hemorrhage; Retinal Detachment; Retinal Perforations; Silicone Oils; Vitrectomy
PubMed: 37260074
DOI: 10.1002/14651858.CD008214.pub4 -
Journal of Thrombosis and Haemostasis :... Sep 2015To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve implantation.
METHODS
Five literature databases were searched to assess the rates of bleeding and thromboembolic events among patients receiving oral anticoagulation (OAC), both with and without bridging anticoagulation therapy with unfractionated heparin (UFH) or subcutaneous low molecular weight heparin (LMWH). The studies' results were pooled via a mixed effects meta-analysis. Heterogeneity (I(2) ) and publication bias were both evaluated.
RESULTS
Twenty-three studies including 9534 patients were included. The bleeding rates were 1.8% (95% confidence interval CI 1.0-3.3) in the group receiving OAC, 2.2% (95% CI 0.9-5.3) in the OAC + UFH group, and 5.5% (95% CI 2.9-10.4) in the OAC + LMWH group (P = 0.042). The thromboembolic event rate was 2.1% (95% CI 1.5-2.9) in the group receiving OAC, as compared with 1.1% (95% CI 0.7-1.8) when the bridging therapy groups were combined as follows: OAC + UFH and OAC + LMWH (P = 0.035). Most of the analyses showed moderate heterogeneity and negative test results for publication bias.
CONCLUSIONS
Bridging therapy following cardiac valve surgery was associated with a lower thromboembolic event rate, although the difference was small, with considerable overlap of the CIs. Direct comparisons are missing. Bridging therapy with UFH appears to be safe; however, this observation has a risk of bias. Early bridging therapy with LMWH appears to be associated with consistently high bleeding rates across multiple analyses. On the basis of the quality of the included studies, more trials are necessary to establish the clinical relevance of bridging therapy and the safety of LMWH.
Topics: Administration, Oral; Anticoagulants; Case-Control Studies; Cohort Studies; Equipment Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemorrhage; Heparin; Heparin, Low-Molecular-Weight; Hospital Mortality; Humans; Postoperative Complications; Postoperative Period; Publication Bias; Thromboembolism; Thrombophilia; Treatment Outcome; Warfarin
PubMed: 26178802
DOI: 10.1111/jth.13047 -
Cureus Dec 2022In the absence of comprehensive data investigating carbetocin versus misoprostol for reducing postpartum hemorrhage (PPH) during cesarean section (CS), we performed this... (Review)
Review
In the absence of comprehensive data investigating carbetocin versus misoprostol for reducing postpartum hemorrhage (PPH) during cesarean section (CS), we performed this investigation to compare the efficiency and side events of carbetocin versus misoprostol in the protection and reduction of PPH for women who underwent CS. From inception to September 2022, we depended on searching through various databases for eligible trials involving Cochrane, Web of Science, PubMed, Scopus, and Google Scholar. From the efficacy prospect, we found that carbetocin substantially decreased intraoperative blood loss (p<0.001), hemoglobin/hematocrit levels (p<0.001), and the need for blood transfusion (p=0.002)/additional surgical interventions (p=0.003) than misoprostol. However, we revealed no substantial variation between both drugs for the need for additional uterotonic agents (p=0.08). From the safety prospect, we found that incidences of fever (p=0.002), heat sensation (p=0.007), metallic taste (p=0.01), and shivering (p=0.0002) were lower in carbetocin administration than in misoprostol. However, headache (p=0.34) and palpitation (p=0.11) incidences revealed no substantial variation between both drugs. In conclusion, from the efficacy and safety prospect, for women who underwent CS, carbetocin is more effective and safer in preventing and reducing PPH than misoprostol.
PubMed: 36578852
DOI: 10.7759/cureus.32901 -
The American Journal of Cardiology Sep 2023Alternative vascular accesses to transfemoral access for transcatheter aortic valve replacement (TAVR) can be divided into intrathoracic (IT)-transapical and... (Meta-Analysis)
Meta-Analysis
Alternative vascular accesses to transfemoral access for transcatheter aortic valve replacement (TAVR) can be divided into intrathoracic (IT)-transapical and transaortic- and extrathoracic (ET)-transcarotid, transsubclavian, and transaxillary. This study aimed to compare the outcomes and safety of IT and ET accesses for TAVR as alternatives to transfemoral access. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all studies comparing IT-TAVR with ET-TAVR published until April 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM), 1-year ACM, postoperative and 30-day complications. A total of 18 studies with 6,800 IT-TAVR patients and 5,032 ET-TAVR patients were included. IT accesses were associated with a significantly higher risk of in-hospital or 30-day ACM (relative risk 1.99, 95% confidence interval 1.67 to 2.36, p <0.001), and 1-year ACM (relative risk 1.31, 95% confidence interval 1.21 to 1.42, p <0.001). IT-TAVR patients presented more often with postoperative life-threatening bleeding, 30-day new-onset atrial fibrillation or flutter, and 30-day acute kidney injury needing renal replacement therapy. The risks of postoperative permanent pacemaker implantation and significant paravalvular leak were lower with IT-TAVR. ET-TAVR patients were more likely to be directly discharged home. There was no statistically significant difference regarding the 30-day risk of stroke. Compared with ET-TAVR, IT-TAVR was associated with higher risks of in-hospital or 30-day ACM, 1-year ACM and higher risks for some critical postprocedural and 30-day complications. Our results suggest that ET-TAVR could be considered as the first-choice alternative approach when transfemoral access is contraindicated.
Topics: Humans; Transcatheter Aortic Valve Replacement; Acute Kidney Injury; Databases, Factual; Hospitals; Postoperative Hemorrhage
PubMed: 37633682
DOI: 10.1016/j.amjcard.2023.07.091 -
The Cochrane Database of Systematic... Jun 2021Postoperative pain is a common consequence of surgery and can have many negative perioperative effects. It has been suggested that the administration of analgesia before... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Postoperative pain is a common consequence of surgery and can have many negative perioperative effects. It has been suggested that the administration of analgesia before a painful stimulus may improve pain control. We defined pre-emptive nonsteroidal anti-inflammatories (NSAIDs) as those given before surgery but not continued afterwards and preventive NSAIDs as those given before surgery and continued afterwards. These were compared to a control group given the NSAIDs after surgery instead of before surgery.
OBJECTIVES
To assess the efficacy of preventive and pre-emptive NSAIDs for reducing postoperative pain in adults undergoing all types of surgery.
SEARCH METHODS
We searched the following electronic databases: CENTRAL, MEDLINE, Embase, AMED and CINAHL (up to June 2020). In addition, we searched for unpublished studies in three clinical trial databases, conference proceedings, grey literature databases, and reference lists of retrieved articles. We did not apply any restrictions on language or date of publication.
SELECTION CRITERIA
We included parallel-group randomized controlled trials (RCTs) only. We included adult participants undergoing any type of surgery. We defined pre-emptive NSAIDs as those given before surgery but not continued afterwards and preventive NSAIDs as those given before surgery and continued afterwards. These were compared to a control group given the NSAIDs after surgery instead of before surgery. We included studies that gave the medication by any route but not given on the skin.
DATA COLLECTION AND ANALYSIS
We used the standard methods expected by Cochrane, as well as a novel publication bias test developed by our research group. We used GRADE to assess the certainty of the evidence for each outcome. Outcomes included acute postoperative pain (minimal clinically important difference (MCID): 1.5 on a 0-10 scale), adverse events of NSAIDs, nausea and vomiting, 24-hour morphine consumption (MCID: 10 mg reduction), time to analgesic request (MCID: one hour), pruritus, sedation, patient satisfaction, chronic pain and time to first bowel movement (MCID: 12 hours).
MAIN RESULTS
We included 71 RCTs. Seven studies are awaiting classification. We included 45 studies that evaluated pre-emptive NSAIDs and 26 studies that evaluated preventive NSAIDs. We considered only four studies to be at low risk of bias for most domains. The operations and NSAIDs used varied, although most studies were conducted in abdominal, orthopaedic and dental surgery. Most studies were conducted in secondary care and in low-risk participants. Common exclusions were participants on analgesic medications prior to surgery and those with chronic pain. Pre-emptive NSAIDs compared to post-incision NSAIDs For pre-emptive NSAIDs, there is probably a decrease in early acute postoperative pain (MD -0.69, 95% CI -0.97 to -0.41; studies = 36; participants = 2032; I = 96%; moderate-certainty evidence). None of the included studies that reported on acute postoperative pain reported adverse events as an outcome. There may be little or no difference between the groups in short-term (RR 1.00, 95% CI 0.34 to 2.94; studies = 2; participants = 100; I = 0%; low-certainty evidence) or long-term nausea and vomiting (RR 0.85, 95% CI 0.52 to 1.38; studies = 5; participants = 228; I = 29%; low-certainty evidence). There may be a reduction in late acute postoperative pain (MD -0.22, 95% CI -0.44 to 0.00; studies = 28; participants = 1645; I = 97%; low-certainty evidence). There may be a reduction in 24-hour morphine consumption with pre-emptive NSAIDs (MD -5.62 mg, 95% CI -9.00 mg to -2.24 mg; studies = 16; participants = 854; I = 99%; low-certainty evidence) and an increase in the time to analgesic request (MD 17.04 minutes, 95% CI 3.77 minutes to 30.31 minutes; studies = 18; participants = 975; I = 95%; low-certainty evidence). There may be little or no difference in opioid adverse events such as pruritus (RR 0.40, 95% CI 0.09 to 1.76; studies = 4; participants = 254; I = 0%; low-certainty evidence) or sedation (RR 0.51, 95% CI 0.16 to 1.68; studies = 4; participants = 281; I = 0%; low-certainty evidence), although the number of included studies for these outcomes was small. No study reported patient satisfaction, chronic pain or time to first bowel movement for pre-emptive NSAIDs. Preventive NSAIDs compared to post-incision NSAIDs For preventive NSAIDs, there may be little or no difference in early acute postoperative pain (MD -0.14, 95% CI -0.39 to 0.12; studies = 18; participants = 1140; I = 75%; low-certainty evidence). One study reported adverse events from NSAIDs (reoperation for bleeding) although the events were low which did not allow any meaningful conclusions to be drawn (RR 1.95; 95% CI 0.18 to 20.68). There may be little or no difference in rates of short-term (RR 1.26, 95% CI 0.49 to 3.30; studies = 1; participants = 76; low-certainty evidence) or long-term (RR 0.85, 95% CI 0.52 to 1.38; studies = 5; participants = 456; I = 29%; low-certainty evidence) nausea and vomiting. There may be a reduction in late acute postoperative pain (MD -0.33, 95% CI -0.59 to -0.07; studies = 21; participants = 1441; I = 81%; low-certainty evidence). There is probably a reduction in 24-hour morphine consumption (MD -1.93 mg, 95% CI -3.55 mg to -0.32 mg; studies = 16; participants = 1323; I = 49%; moderate-certainty evidence). It is uncertain if there is any difference in time to analgesic request (MD 8.51 minutes, 95% CI -31.24 minutes to 48.27 minutes; studies = 8; participants = 410; I = 98%; very low-certainty evidence). As with pre-emptive NSAIDs, there may be little or no difference in other opioid adverse events such as pruritus (RR 0.56, 95% CI 0.09 to 3.35; studies = 3; participants = 211; I = 0%; low-certainty evidence) and sedation (RR 0.84, 95% CI 0.44 to 1.63; studies = 5; participants = 497; I = 0%; low-certainty evidence). There is probably little or no difference in patient satisfaction (MD -0.42; 95% CI -1.09 to 0.25; studies = 1; participants = 72; moderate-certainty evidence). No study reported on chronic pain. There is probably little or no difference in time to first bowel movement (MD 0.00; 95% CI -15.99 to 15.99; studies = 1; participants = 76; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
There was some evidence that pre-emptive and preventive NSAIDs reduce both pain and morphine consumption, although this was not universal for all pain and morphine consumption outcomes. Any differences found were not clinically significant, although we cannot exclude this in more painful operations. Moreover, without any evidence of reductions in opioid adverse effects, the clinical significance of these results is questionable although few studies reported these outcomes. Only one study reported clinically significant adverse events from NSAIDs administered before surgery and, therefore, we have very few data to assess the safety of either pre-emptive or preventive NSAIDs. Therefore, future research should aim to adhere to the highest methodology and be adequately powered to assess serious adverse events of NSAIDs and reductions in opioid adverse events.
Topics: Acute Pain; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Bias; Confidence Intervals; Cyclooxygenase 2 Inhibitors; Humans; Morphine; Pain, Postoperative; Patient Satisfaction; Postoperative Hemorrhage; Postoperative Nausea and Vomiting; Pruritus; Randomized Controlled Trials as Topic; Reoperation; Surgical Procedures, Operative
PubMed: 34125958
DOI: 10.1002/14651858.CD012978.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 2023Chronic rhinosinusitis, with or without nasal polyps, can have a major impact on a person's quality of life. Treatment is usually conservative and may include nasal... (Review)
Review
BACKGROUND
Chronic rhinosinusitis, with or without nasal polyps, can have a major impact on a person's quality of life. Treatment is usually conservative and may include nasal saline, intranasal corticosteroids, antibiotics or systemic corticosteroids. If these treatments fail endoscopic sinus surgery can be considered. During surgery, visibility of the surgical field is important for the identification of important anatomic landmarks and structures that contribute to safety. Impaired visualisation can lead to complications during surgery, inability to complete the operation or a longer duration of surgery. Different methods are used to decrease intraoperative bleeding, including induced hypotension, topical or systemic vasoconstrictors or total intravenous anaesthesia. Another option is tranexamic acid, an antifibrinolytic agent, which can be administered topically or intravenously.
OBJECTIVES
To assess the effects of peri-operative tranexamic acid versus no therapy or placebo on operative parameters in patients with chronic rhinosinusitis (with or without nasal polyps) who are undergoing functional endoscopic sinus surgery (FESS).
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 10 February 2022.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing intravenous, oral or topical tranexamic acid with no therapy or placebo in the treatment of patients (adults and children) with chronic rhinosinusitis, with or without nasal polyps, undergoing FESS.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Primary outcome measures were surgical field bleeding score (e.g. Wormald or Boezaart grading system), intraoperative blood loss and significant adverse effects (seizures or thromboembolism within 12 weeks of surgery). Secondary outcomes were duration of surgery, incomplete surgery, surgical complications and postoperative bleeding (placing of packing or revision surgery) in the first two weeks after surgery. We performed subgroup analyses for methods of administration, different dosages, different forms of anaesthesia, use of thromboembolic prophylaxis and children versus adults. We evaluated each included study for risk of bias and used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included 14 studies in the review, with a total of 942 participants. Sample sizes in the included studies ranged from 10 to 170. All but two studies included adult patients (≥ 18 years). Two studies included children. Most studies had more male patients (range 46.6% to 80%). All studies were placebo-controlled and four studies had three treatment arms. Three studies investigated topical tranexamic acid; the other studies reported the use of intravenous tranexamic acid. For our primary outcome, surgical field bleeding score measured with the Boezaart or Wormald grading score, we pooled data from 13 studies. The pooled result demonstrated that tranexamic acid probably reduces the surgical field bleeding score, with a standardised mean difference (SMD) of -0.87 (95% confidence interval (CI) -1.23 to -0.51; 13 studies, 772 participants; moderate-certainty evidence). A SMD below -0.70 represents a large effect (in either direction). Tranexamic acid may result in a slight reduction in blood loss during surgery compared to placebo with a mean difference (MD) of -70.32 mL (95% CI -92.28 to -48.35 mL; 12 studies, 802 participants; low-certainty evidence). Tranexamic acid probably has little to no effect on the development of significant adverse events (seizures or thromboembolism) within 24 hours of surgery, with no events in either group and a risk difference (RD) of 0.00 (95% CI -0.02 to 0.02; 8 studies, 664 participants; moderate-certainty evidence). However, there were no studies reporting significant adverse event data with a longer duration of follow-up. Tranexamic acid probably results in little difference in the duration of surgery with a MD of -13.04 minutes (95% CI -19.27 to -6.81; 10 studies, 666 participants; moderate-certainty evidence). Tranexamic acid probably results in little to no difference in the incidence of incomplete surgery, with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence) and likely results in little to no difference in surgical complications, again with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence), although these numbers are too small to draw robust conclusions. Tranexamic acid may result in little to no difference in the likelihood of postoperative bleeding (placement of packing or revision surgery within three days of surgery) (RD -0.01, 95% CI -0.04 to 0.02; 6 studies, 404 participants; low-certainty evidence). There were no studies with longer follow-up.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence to support the beneficial value of topical or intravenous tranexamic acid during endoscopic sinus surgery with respect to surgical field bleeding score. Low- to moderate-certainty evidence suggests a slight decrease in total blood loss during surgery and duration of surgery. Whilst there is moderate-certainty evidence that tranexamic acid does not lead to more immediate significant adverse events compared to placebo, there is no evidence regarding the risk of serious adverse events more than 24 hours after surgery. There is low-certainty evidence that tranexamic acid may not change postoperative bleeding. There is not enough evidence available to draw robust conclusions about incomplete surgery or surgical complications.
Topics: Adult; Child; Humans; Administration, Intranasal; Adrenal Cortex Hormones; Hemorrhage; Nasal Polyps; Tranexamic Acid
PubMed: 36808096
DOI: 10.1002/14651858.CD012843.pub2 -
Surgical Neurology International 2023This study provides a comprehensive overview of the management of postoperative vasospasm after skull base surgeries. This phenomenon is rare but can be of serious...
BACKGROUND
This study provides a comprehensive overview of the management of postoperative vasospasm after skull base surgeries. This phenomenon is rare but can be of serious sequelae.
METHODS
Medline, Embase, and PubMed Central were searched, along with examining the references of the included studies. Only case reports and series that reported vasospasm following a skull base pathology were incorporated. Cases with pathologies other than skull base, subarachnoid hemorrhage, aneurysm, and reversible cerebral vasoconstriction syndrome were excluded from the study. Quantitative data were presented as mean (Standard Deviation) or median (range), accordingly, while qualitative data were presented as frequency (percentage). Chi- square test and one-way analysis of variance were used to assess for any association between the different factors and patient outcomes.
RESULTS
We had a total of 42 cases extracted from the literature. The mean age was 40.1 (±16.1) with approximately equal males and females (19 [45.2%] and 23 [54.8%], respectively). The time to develop vasospasm after the surgery was 7 days (±3.7). Most of the cases were diagnosed by either angiogram or magnetic resonance angiography. Seventeen of the 42 patients had pituitary adenoma as the pathology. Anterior circulation was nearly affected in all patients. For management, most patients received pharmacological with supportive management. Twenty-three patients had an incomplete recovery as a result of vasospasm.
CONCLUSION
Vasospasm following skull base operations can affect males and females, and most patients in this review were middle-aged adults. The outcome of patients varies; however, most patients did not achieve a full recovery. There was no correlation between any factors and the outcome.
PubMed: 37404488
DOI: 10.25259/SNI_441_2023