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PloS One 2017This systematic review and meta-analysis aims to determine the current evidence on risk factors for type II endoleaks after endovascular aneurysm repair (EVAR). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This systematic review and meta-analysis aims to determine the current evidence on risk factors for type II endoleaks after endovascular aneurysm repair (EVAR).
MATERIALS AND METHODS
A systematic literature search was carried out for studies that evaluated the association of demographic, co-morbidity, and other patient-determined factors with the onset of type II endoleaks. Pooled prevalence of type II endoleaks after EVAR was updated.
RESULTS
Among the 504 studies screened, 45 studies with a total of 36,588 participants were included in this review. The pooled prevalence of type II endoleaks after EVAR was 22% [95% confidence interval (CI), 19%-25%]. The main factors consistently associated with type II endoleaks included age [pooled odds ratio (OR), 0.37; 95% CI, 0.31-0.43; P<0.001], smoking (pooled OR, 0.71; 95% CI, 0.55-0.92; P<0.001), patent inferior mesenteric artery (pooled OR, 1.98; 95% CI, 1.06-3.71; P = 0.012), maximum aneurysm diameter (pooled OR, 0.23; 95% CI, 0.17-0.30; P<0.001), and number of patent lumbar arteries (pooled OR, 3.07; 95% CI, 2.81-3.33; P<0.001). Sex, diabetes, hypertension, anticoagulants, antiplatelet, hyperlipidemia, chronic renal insufficiency, types of graft material, and chronic obstructive pulmonary diseases (COPD) did not show any association with the onset of type II endoleaks.
CONCLUSIONS
Clinicians can use the identified risk factors to detect and manage patients at risk of developing type II endoleaks after EVAR. However, further studies are needed to analyze a number of potential risk factors.
Topics: Endoleak; Humans; Prevalence; Risk Factors; Vascular Surgical Procedures
PubMed: 28182753
DOI: 10.1371/journal.pone.0170600 -
The Cochrane Database of Systematic... Aug 2017Tonsillectomy is a very common operation and is performed using various surgical methods. Coblation is a popular method because it purportedly causes less pain than... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tonsillectomy is a very common operation and is performed using various surgical methods. Coblation is a popular method because it purportedly causes less pain than other surgical methods. However, the superiority of coblation is unproven.
OBJECTIVES
To compare the effects of coblation tonsillectomy for chronic tonsillitis or tonsillar hypertrophy with other surgical techniques, both hot and cold, on intraoperative morbidity, postoperative morbidity and procedural cost.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2017, Issue 3); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 April 2017.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of children and adults undergoing tonsillectomy with coblation compared with any other surgical technique. This review is limited to trials of extracapsular (traditional) tonsillectomy and excludes trials of intracapsular tonsil removal (tonsillotomy).
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methods. Our primary outcomes were: patient-reported pain using a validated pain scale at postoperative days 1, 3 and 7; intraoperative blood loss; primary postoperative bleeding (within 24 hours) and secondary postoperative bleeding (more than 24 hours after surgery). Secondary outcomes were: time until resumption of normal diet, time until resumption of normal activity, duration of surgery and adverse effects including blood transfusion and the need for reoperation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included 29 studies, with a total of 2561 participants. All studies had moderate or high risk of bias. Sixteen studies used an adequate randomisation technique, however the inability to mask the surgical teams and/or provide adequate methods to mitigate the risk of bias put nearly all studies at moderate or high risk of detection and measurement bias for intraoperative blood loss, and primary and secondary bleeding. In contrast most studies (20) were at low risk of bias for pain assessment. Most studies did not report data in a manner permitting meta-analysis.Most studies did not clearly report the participant characteristics, surgical indications or whether patients underwent tonsillectomy or adenotonsillectomy. Most studies reported that tonsillitis (infection) and/or tonsillar hypertrophy (obstruction) were the indication for surgery. Seven studies included only adults, 16 studies included only children and six studies included both. Pain At postoperative day 1 there is very low quality evidence that patients in the coblation group had less pain, with a standardised mean difference (SMD) of -0.79 (95% confidence interval (CI) -1.38 to -0.19; 538 participants; six studies). This effect is reduced a SMD of -0.44 (95% CI -0.97 to 0.09; 401 participants; five studies; very low-quality evidence) at day 3, and at day 7 there is low quality evidence of little or no difference in pain (SMD -0.01, 95% CI -0.22 to 0.19; 420 participants; five studies). Although this suggests that pain may be slightly less in the coblation group between days 1 and 3, the clinical significance is unclear. Intraoperative blood loss Methodological differences between studies in the measurement of intraoperative blood loss precluded meta-analysis. Primary and secondary bleeding The risk of primary bleeding was similar (risk ratio (RR) 0.99, 95% CI 0.48 to 2.05; 2055 participants; 25 studies; low-quality evidence). The risk of secondary bleeding was greater in the coblation group with a risk ratio of 1.36 (95% CI 0.95 to 1.95; 2118 participants; 25 studies; low-quality evidence). Using the median of the control group as the baseline risk, the absolute risk in the coblation group was 5% versus 3.6% in the control group. The difference of 1.3% has a 95% CI of 0.2% lower in the coblation group to 3.5% higher. Secondary outcomes Differences in study design and data reporting precluded the identification of differences in the time to resumption of normal diet or activity, or whether there was a difference in the duration of surgery.Although we could not feasibly compare the costs of equipment or operative facility, anaesthetic and surgical fees across different healthcare systems we used duration of surgery as a proxy for cost. Although this outcome was commonly reported in studies, it was not possible to pool the data to determine whether there was a difference.Adverse events other than bleeding were not well reported. It is unclear whether there is a difference in postoperative infections or the need for reoperation.
AUTHORS' CONCLUSIONS
The coblation technique may cause less pain on postoperative day 1, but the difference is small and may be clinically meaningless. By postoperative day 3, the difference decreases further and by postoperative day 7 there appears to be little or no difference. We found similar rates of primary bleeding but we cannot rule out a small increased risk of secondary bleeding with coblation. The evidence supporting these findings is of low or very low quality, i.e. there is a very high degree of uncertainty about the results. Moreover, for most outcomes data were only available from a few of the 29 included studies.The current evidence is of very low quality, therefore it is uncertain whether or not the coblation technique has any advantages over traditional tonsillectomy techniques. Despite the large number of studies, failure to use standardised or validated outcome measures precludes the ability to pool data across studies. Therefore, well-conducted RCTs using consistent, validated outcome measures are needed to establish whether the coblation technique has a benefit over other methods. In the included studies we identified no clear difference in adverse events. However, given the rarity of these events, randomised trials lack the power to detect a difference. Data from large-scale registries will provide a better estimate of any difference in these rare outcomes.
Topics: Adult; Catheter Ablation; Child; Humans; Hypertrophy; Pain, Postoperative; Palatine Tonsil; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Sodium Chloride; Tonsillectomy; Tonsillitis
PubMed: 28828761
DOI: 10.1002/14651858.CD004619.pub3 -
Systematic Reviews Dec 2014Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding.... (Review)
Review
BACKGROUND
Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding. Baseline risks, in the absence of prophylaxis, for VTE and bleeding are known to vary widely between urological procedures, but their magnitude is highly uncertain. Systematic reviews and meta-analyses addressing baseline risks are uncommon, needed, and require methodological innovation. In this article, we describe the rationale and methods for a series of systematic reviews of the risks of symptomatic VTE and bleeding requiring reoperation in urological surgery.
METHODS/DESIGN
We searched MEDLINE from January 1, 2000 until April 10, 2014 for observational studies reporting on symptomatic VTE or bleeding after urological procedures. Additional studies known to experts and studies cited in relevant review articles were added. Teams of two reviewers, independently assessed articles for eligibility, evaluated risk of bias, and abstracted data. We derived best estimates of risk from the median estimates among studies rated at the lowest risk of bias. The primary endpoints were 30-day post-operative risk estimates of symptomatic VTE and bleeding requiring reoperation, stratified by procedure and patient risk factors.
DISCUSSION
This series of systematic reviews will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding. Our work advances standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at best estimates of risk (including modeling of timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate certainty in estimates of risk. The results will be incorporated in the upcoming European Association Urology Guideline on Thromboprophylaxis.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42014010342.
Topics: Hemorrhage; Humans; Observational Studies as Topic; Postoperative Complications; Research Design; Thromboembolism; Urologic Surgical Procedures
PubMed: 25540016
DOI: 10.1186/2046-4053-3-150 -
World Journal of Surgical Oncology Feb 2024Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic events (VTE) remains unclear. This study aimed to investigate the efficacy and safety of DOACs versus LMWH in these patients.
MATERIALS AND METHODS
A search of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science was carried out and included all randomized controlled trials (RCTs) and observational studies that directly compared DOACs with LMWH for thromboprophylaxis in patients after cancer surgery through July 25, 2023. The primary efficacy and safety outcomes were VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB) within 30 days of surgery. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) tool for RCTs and ROBINS-I tool for non-randomized studies. This study was registered in PROSPERO (CRD42023445386).
RESULTS
We retrieved 5149articles, selected 27 for eligibility, and included 10 studies (three RCTs and seven observational studies) encompassing 3054 patients who underwent postoperative thromboprophylaxis with DOACs (41%) or LMWH (59%). Compared to LMWH thromboprophylaxis, DOACs had a comparable risk of VTE (RR:0.69[95% CI:0.46-1.02], I = 0%), major bleeding (RR:1.55 [95% CI:0.82-2.93], I = 2%), and CRNMB (RR, 0.89 [95% CI, 0.4-1.98], I = 31%) during the 30-day postoperative period. Subgroup analysis of VTE and major bleeding suggested no differences according to study type, extended thromboprophylaxis, tumor types, or different types of DOAC.
CONCLUSION
DOACs are potentially effective alternatives to LMWH for thromboprophylaxis in patients undergoing cancer surgery, without increasing the risk of major bleeding events.
Topics: Humans; Heparin, Low-Molecular-Weight; Anticoagulants; Venous Thromboembolism; Hemorrhage; Neoplasms
PubMed: 38403630
DOI: 10.1186/s12957-024-03341-5 -
Frontiers in Surgery 2022Mortality and morbidity following hepatic resection is significantly affected by major intra-operative blood loss. This systematic review and meta-analysis evaluates... (Review)
Review
OBJECTIVES
Mortality and morbidity following hepatic resection is significantly affected by major intra-operative blood loss. This systematic review and meta-analysis evaluates whether selective hepatic vascular exclusion (SHVE) compared to a Pringle maneuver in hepatic resection reduces rates of morbidity and mortality.
METHODS
A systematic review and meta-analysis were conducted according to the PRISMA guidelines by screening EMBASE, MEDLINE/PubMed, CENTRAL and SCOPUS for comparative studies meeting the inclusion criteria. Pooled odds ratios or mean differences were calculated for outcomes using either fixed- or random-effects models.
RESULTS
Six studies were identified: three randomised controlled trials and three observational studies reporting a total of 2,238 patients. Data synthesis showed significantly decreased rates of mortality, overall complications, blood loss, transfusion requirements, air embolism, liver failure and multi-organ failure in the SHVE group. Rates of hepatic vein rupture, post-operative hemorrhage, operative and warm ischemia time, length of stay in hospital and intensive care unit were not statistically significant between the two groups.
CONCLUSION
Performing SHVE in major hepatectomy may result in reduced rates of morbidity and mortality when compared to a Pringle maneuver. The results of this meta-analysis are based on studies where tumors were adjacent to major vessels. Further RCTs are required to validate these results.
CLINICAL TRIAL REGISTRATION
PROSPERO (CRD42020212372) https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=212372.
PubMed: 35465416
DOI: 10.3389/fsurg.2022.860721 -
Medicine Dec 2017Minimally invasive pancreaticoduodenectomy (MIPD) remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Minimally invasive pancreaticoduodenectomy (MIPD) remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing MIPD with open pancreaticoduodenectomy (OPD). The aim of this systematic review and meta-analysis was to evaluate the feasibility and safety of MIPD versus OPD.
METHODS
A systematic review of the literature was performed to identify studies comparing MIPD and OPD. Postoperative complications, intraoperative outcomes and oncologic data, and postoperative recovery were compared.
RESULTS
There were 27 studies that matched the selection criteria. Totally 1306 cases of MIPD and 5603 cases of OPD were included. MIPD was associated with a reduction in postoperative hemorrhage (odds ratio [OR] 1.60; 95% confidence interval [CI] 1.03-2.49; P = .04) and wound infection (OR 0.44, 95% CI 0.30-0.66, P < .0001). MIPD was also associated with less estimated blood loss (mean difference [MD] -300.14 mL, 95% CI -400.11 to -200.17 mL, P < .00001), a lower transfusion rate (OR 0.46, 95% CI 0.35-0.61; P < .00001) and a shorter length of hospital stay (MD -2.95 d, 95% CI -3.91 to -2.00 d, P < .00001) than OPD. Meanwhile, the MIPD group had a higher R0 resection rate (OR 1.45, 95% CI 1.18-1.78, P = .0003) and more lymph nodes harvested (MD 1.34, 95% CI 0.14-2.53, P = .03). However, the minimally invasive approach proved to have much longer operative time (MD 71.00 minutes; 95% CI 27.01-115.00 minutes; P = .002) than OPD. Finally, there were no significant differences between the 2 procedures in postoperative pancreatic fistula (P = .30), delayed gastric emptying (P = .07), bile leakage (P = .98), mortality (P = .88), tumor size (P = .15), vascular resection (P = .68), or reoperation rate (P = .11).
CONCLUSIONS
Our results suggest that MIPD is currently safe, feasible, and worthwhile. Future large-volume, well-designed randomized controlled trials (RCT) with extensive follow-up are awaited to further clarify this role.
Topics: Blood Loss, Surgical; Blood Transfusion; Humans; Laparoscopy; Length of Stay; Pancreaticoduodenectomy; Postoperative Complications; Surgical Procedures, Operative
PubMed: 29390259
DOI: 10.1097/MD.0000000000008619 -
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 -
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 -
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 -
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