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American Journal of Obstetrics and... Apr 2024This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries.
DATA SOURCES
We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar. Furthermore, we performed separate searches for randomized trials that addressed the effects of thromboprophylaxis.
STUDY ELIGIBILITY CRITERIA
Eligible studies were observational studies that enrolled ≥50 adult patients who underwent noncancer gynecologic surgery procedures and that reported the absolute incidence of at least 1 of the following: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding that required reintervention (including re-exploration and angioembolization), bleeding that led to transfusion, or postoperative hemoglobin level <70 g/L.
METHODS
A teams of 2 reviewers independently assessed eligibility, performed data extraction, and evaluated the risk of bias of the eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine the cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors and used the Grading of Recommendations Assessment, Development and Evaluation approach to rate the evidence certainty.
RESULTS
We included 131 studies (1,741,519 patients) that reported venous thromboembolism risk estimates for 50 gynecologic noncancer procedures and bleeding requiring reintervention estimates for 35 procedures. The evidence certainty was generally moderate or low for venous thromboembolism and low or very low for bleeding requiring reintervention. The risk for symptomatic venous thromboembolism varied from a median of <0.1% for several procedures (eg, transvaginal oocyte retrieval) to 1.5% for others (eg, minimally invasive sacrocolpopexy with hysterectomy, 1.2%-4.6% across patient venous thromboembolism risk groups). Venous thromboembolism risk was <0.5% for 30 (60%) of the procedures; 0.5% to 1.0% for 10 (20%) procedures; and >1.0% for 10 (20%) procedures. The risk for bleeding the require reintervention varied from <0.1% (transvaginal oocyte retrieval) to 4.0% (open myomectomy). The bleeding requiring reintervention risk was <0.5% in 17 (49%) procedures, 0.5% to 1.0% for 12 (34%) procedures, and >1.0% in 6 (17%) procedures.
CONCLUSION
The risk for venous thromboembolism in gynecologic noncancer surgery varied between procedures and patients. Venous thromboembolism risks exceeded the bleeding risks only among selected patients and procedures. Although most of the evidence is of low certainty, the results nevertheless provide a compelling rationale for restricting pharmacologic thromboprophylaxis to a minority of patients who undergo gynecologic noncancer procedures.
Topics: Adult; Humans; Female; Anticoagulants; Venous Thromboembolism; Postoperative Complications; Hemorrhage; Thrombosis; Gynecologic Surgical Procedures
PubMed: 38072372
DOI: 10.1016/j.ajog.2023.11.1255 -
BMC Surgery Aug 2023Preventive colostomy is required for colorectal surgery, and the incidence of complications associated with ileostomy and colostomy remains controversial. This study... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Preventive colostomy is required for colorectal surgery, and the incidence of complications associated with ileostomy and colostomy remains controversial. This study aimed to compare the incidence of postoperative complications between ileostomy and colostomy procedures.
METHODS
Data analysis was conducted on 30 studies, and meta-analysis and trial sequential analysis (TSA) were performed on five studies. The basic indicators, such as stoma prolapse, leak, wound infection, ileus, and a series of other indicators, were compared.
RESULTS
No statistically significant differences were observed with complications other than stoma prolapse. Meta-analysis and TSA showed that the incidence of ileostomy prolapse was lower than that of colostomy prolapse, and the difference was statistically significant. Apart from the four complications listed above, the general data analysis showed differences in incidence between the two groups. The incidence of skin irritation, parastomal hernia, dehydration, pneumonia, and urinary tract infections was higher with ileostomy than with colostomy. In contrast, the incidence of parastomal fistula, stenosis, hemorrhage, and enterocutaneous fistula was higher with colostomy than with ileostomy.
CONCLUSIONS
There were differences in the incidence of ileostomy and colostomy complications in the selected studies, with a low incidence of ileostomy prolapse.
PROSPERO REGISTRATION NUMBER
CRD42022303133.
Topics: Humans; Colostomy; Ileostomy; Anastomosis, Surgical; Postoperative Complications; Prolapse
PubMed: 37568176
DOI: 10.1186/s12893-023-02129-w -
Journal of the American Heart... Aug 2015There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to... (Review)
Review
BACKGROUND
There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials.
METHODS AND RESULTS
We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each.
CONCLUSIONS
Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery.
Topics: Cardiac Surgical Procedures; Cause of Death; Clinical Trials as Topic; Endpoint Determination; Humans; Myocardial Infarction; Postoperative Hemorrhage; Renal Insufficiency; Research Design; Stroke; Time Factors; Treatment Outcome
PubMed: 26282561
DOI: 10.1161/JAHA.115.002204 -
Journal of Oral & Maxillofacial Research 2021The systematic literature review aims to assess patients' dental extraction with inherited bleeding disorders, to understand the type, dosage, and modality of... (Review)
Review
OBJECTIVES
The systematic literature review aims to assess patients' dental extraction with inherited bleeding disorders, to understand the type, dosage, and modality of administration of the haemostatic agents for safe intra- and postoperational results.
MATERIAL AND METHODS
The search was undertaken in MEDLINE (PubMed) databases and Cochrane library for articles published in English from 1 January, 2010 till 31 October, 2020. Before the full-text articles were considered, titles and abstracts were screened.
RESULTS
A total of 78 articles were screened, from which 3 met the necessary criteria and were used for the review. Minor complications, such as postoperative bleedings from the socket and epistaxis, were observed, but they were resolved with proper medical care. No major fatal complications were reported. Generally, all the articles provided evidence of successful extractions with correct treatment plans made by haematologists and surgeons.
CONCLUSIONS
Available clinical trials demonstrate that local and systemic haemostatic therapies in combination are effective in preventing bleeding during dental extractions in patients with coagulopathies.
PubMed: 34377378
DOI: 10.5037/jomr.2021.12201 -
Cureus Mar 2022This study aimed to compare the outcomes of coblation versus bipolar diathermy in pediatric patients undergoing tonsillectomy. A systematic review and meta-analysis were... (Review)
Review
This study aimed to compare the outcomes of coblation versus bipolar diathermy in pediatric patients undergoing tonsillectomy. A systematic review and meta-analysis were performed per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines. An electronic search of information was conducted to identify all Randomized Controlled Trials (RCTs) comparing the outcomes of coblation versus bipolar in pediatric patients undergoing tonsillectomy. Primary outcome measures were intraoperative bleeding, reactionary hemorrhage, delayed hemorrhage, and post-operative pain. Secondary outcome measures included a return to a normal diet, effects on the tonsillar bed, operation time, and administration of analgesia. Fixed and random-effects models were used for the analysis. Seven studies enrolling 1328 patients were identified. There was a significant difference between coblation and bipolar groups in terms of delayed hemorrhage (Odds Ratio [OR] = 0.27, P = 0.005) and post-operative pain (standardized mean difference [MD] = -2.13, P = 0.0007). Intraoperative bleeding (MD = -43.26, P = 0.11) and reactionary hemorrhage did not show any significant difference. The coblation group improved analgesia administration, diet and tonsillar tissue recovery, and thermal damage for secondary outcomes. No significant difference was reported in terms of operation time. In conclusion, coblation is comparable to a bipolar technique for pediatric patients undergoing tonsillectomy. It improves postoperative pain and delayed hemorrhage and does not worsen intraoperative bleeding and reactionary hemorrhage.
PubMed: 35419233
DOI: 10.7759/cureus.23066 -
Journal of Vascular Surgery Oct 2022Iliac branch devices (IBDs) have been used in the treatment of aortoiliac and isolated iliac artery aneurysms. The aim of this systematic review and meta-analysis was to... (Meta-Analysis)
Meta-Analysis Review
A systematic review and meta-analysis of the clinical effectiveness and safety of unilateral versus bilateral iliac branch devices for aortoiliac and iliac artery aneurysms.
OBJECTIVE
Iliac branch devices (IBDs) have been used in the treatment of aortoiliac and isolated iliac artery aneurysms. The aim of this systematic review and meta-analysis was to investigate the clinical effectiveness and safety of IBDs.
METHODS
A systematic review of the literature was conducted by identifying studies in the Medline, EMBASE, and Cochrane databases regarding the outcomes of IBDs in aortoiliac or isolated iliac artery aneurysms between May 2006 and December 2020. Individual studies were evaluated for the following major outcomes: technical success, 30-day mortality, primary patency, endoleak, reintervention, and rates of pelvic ischemia. Furthermore, subgroup meta-analyses were performed to compare the pelvic ischemic events in patients with bilateral IBDs, unilateral IBDs, and bilateral internal iliac artery (IIA) embolization/coverage.
RESULTS
Forty-five studies with a total of 2736 patients undergoing unilateral or bilateral IBDs met inclusion criteria and were included in the analysis. The pooled technical success rate of IBDs was 98.0% (confidence interval [CI]: 97.3%-98.7%). After IBD treatment, the 30-day mortality rate was 0.4% (CI: 0.07%-0.70%); 30-day patency was 98.4% (CI: 97.7%-99.0%); buttock claudication developed in 1.84% (CI: 1.26%-2.41%); and endoleak occurred in 11.9% (CI: 9.2%-14.7%) and reintervention in 7.6% (CI: 5.65%-9.58%). Furthermore, in patients with bilateral iliac artery involvement, the pooled estimate rates of buttock claudication were 0.7% in the bilateral IBD group, 7.9% in unilateral IBD with contralateral IIA embolization patients, and 33.8% in bilateral IIA embolization/coverage patients, which were statistically significant among the three groups. Sexual dysfunction was 5.0% in the bilateral IIA occlusion group, which was significantly higher than that in IBD groups.
CONCLUSIONS
The utilization of IBDs in the treatment of aortoiliac or isolated iliac artery aneurysms is associated with high technical success rates as well as low incidences of pelvic ischemia. The risk of postoperative buttock claudication can be further decreased with both IIA preservation if patients are anatomically suitable for bilateral IBDs.
Topics: Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endoleak; Endovascular Procedures; Humans; Iliac Aneurysm; Iliac Artery; Intermittent Claudication; Ischemia; Prosthesis Design; Stents; Treatment Outcome
PubMed: 35314303
DOI: 10.1016/j.jvs.2022.03.005 -
Arab Journal of Urology 2022To determine the advantages and disadvantages of both methods by comparing classic circumcision methods with circumcision methods assisted by ring instruments. (Review)
Review
AIM
To determine the advantages and disadvantages of both methods by comparing classic circumcision methods with circumcision methods assisted by ring instruments.
MATERIAL-METHODS
Only studies that compared open procedures and ring devices for male circumcision were included. A total of 6226 patients were examined in 14 studies. The methodological quality of RCT was evaluated using Cochrane collaboration's tools. The Review Manager software statistical package was used to analyze the ORs for dichotomous variables and the mean differences for continuous variables. The proportion of heterogeneity across the studies was tested using the I 2 index. Potential publication bias was assessed by identifying the presence of visual asymmetry/symmetry with funnel plot studies.
RESULTS
There were 1812 patients in the open circumcision group and 4414 patients in the ring groups. In total, there was no difference identified between the groups. The open procedure had an advantage compared to the Plastibell subgroup for hemorrhage, while in the other two subgroups, the ring instrument groups had the advantage. Statistically significant in favor of ring devices was found in operating time.There was no difference between the groups for early (postoperative) pain scores. For late-period pain scores, differences with statistical significance were identified in favor of ring devices both in subgroups and in total. For satisfaction, apart from one study in the PrePex group, statistical significance was obtained in favor of ring devices for the other subgroups and in total.
CONCLUSION
The main factors in favor of the use of ring instruments for circumcision are the short total surgical duration, not requiring advanced surgical experience, ease of learning and application, and patient relative satisfaction rates. However, it is a condition to know open circumcision methods and to have experience of this surgery for use in situations with hemorrhage complications, mainly, and without ring instruments of appropriate size.
PubMed: 35935913
DOI: 10.1080/2090598X.2022.2071545 -
The Cochrane Database of Systematic... Feb 2023Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor, with no transfusion requirement, to massive, requiring multiple blood product transfusions. There are a number of drugs, given systemically or applied locally, which may reduce the need for blood transfusion.
OBJECTIVES
To assess the effectiveness and safety of anti-fibrinolytic and haemostatic drugs and agents in reducing bleeding and the need for blood transfusion in people undergoing major vascular surgery or vascular procedures with a risk of moderate or severe (> 500 mL) blood loss.
SEARCH METHODS
We searched: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL, and Transfusion Evidence Library. We also searched the WHO ICTRP and ClinicalTrials.gov trial registries for ongoing and unpublished trials. Searches used a combination of MeSH and free text terms from database inception to 31 March 2022, without restriction on language or publication status.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in adults of drug treatments to reduce bleeding due to major vascular surgery or vascular procedures with a risk of moderate or severe blood loss, which used placebo, usual care or another drug regimen as control.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were units of red cells transfused and all-cause mortality. Our secondary outcomes included risk of receiving an allogeneic blood product, risk of reoperation or repeat procedure due to bleeding, risk of a thromboembolic event, risk of a serious adverse event and length of hospital stay. We used GRADE to assess certainty of evidence.
MAIN RESULTS
We included 22 RCTs with 3393 participants analysed, of which one RCT with 69 participants was reported only in abstract form, with no usable data. Seven RCTs evaluated systemic drug treatments (three aprotinin, two desmopressin, two tranexamic acid) and 15 RCTs evaluated topical drug treatments (drug-containing bioabsorbable dressings or glues), including fibrin, thrombin, collagen, gelatin, synthetic sealants and one investigational new agent. Most trials were conducted in high-income countries and the majority of the trials only included participants undergoing elective surgery. We also identified two ongoing RCTs. We were unable to perform the planned network meta-analysis due to the sparse reporting of outcomes relevant to this review. Systemic drug treatments We identified seven trials of three systemic drugs: aprotinin, desmopressin and tranexamic acid, all with placebo controls. The trials of aprotinin and desmopressin were small with very low-certainty evidence for all of our outcomes. Tranexamic acid versus placebo was the systemic drug comparison with the largest number of participants (2 trials; 1460 participants), both at low risk of bias. The largest of these included a total of 9535 individuals undergoing a number of different higher risk surgeries and reported limited information on the vascular subgroup (1399 participants). Neither trial reported the number of units of red cells transfused per participant up to 30 days. Three outcomes were associated with very low-certainty evidence due to the very wide confidence intervals (CIs) resulting from small study sizes and low number of events. These were: all-cause mortality up to 30 days; number of participants requiring an allogeneic blood transfusion up to 30 days; and risk of requiring a repeat procedure or operation due to bleeding. Tranexamic acid may have no effect on the risk of thromboembolic events up to 30 days (risk ratio (RR) 1.10, 95% CI 0.88 to 1.36; 1 trial, 1360 participants; low-certainty evidence due to imprecision). There is one large ongoing trial (8320 participants) comparing tranexamic acid versus placebo in people undergoing non-cardiac surgery who are at high risk of requiring a red cell transfusion. This aims to complete recruitment in April 2023. This trial has primary outcomes of proportion of participants transfused with red blood cells and incidence of venous thromboembolism (DVT or PE). Topical drug treatments Most trials of topical drug treatments were at high risk of bias due to their open-label design (compared with usual care, or liquids were compared with sponges). All of the trials were small, most were very small, and few reported clinically relevant outcomes in the postoperative period. Fibrin sealant versus usual care was the topical drug comparison with the largest number of participants (5 trials, 784 participants). The five trials that compared fibrin sealant with usual care were all at high risk of bias, due to the open-label trial design with no measures put in place to minimise reporting bias. All of the trials were funded by pharmaceutical companies. None of the five trials reported the number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. The other three outcomes were associated with very low-certainty evidence with wide confidence intervals due to small sample sizes and the low number of events, these were: all-cause mortality up to 30 days; risk of requiring a repeat procedure due to bleeding; and risk of thromboembolic disease up to 30 days. We identified one large trial (500 participants) comparing fibrin sealant versus usual care in participants undergoing abdominal aortic aneurysm repair, which has not yet started recruitment. This trial lists death due to arterial disease and reintervention rates as primary outcomes.
AUTHORS' CONCLUSIONS
Because of a lack of data, we are uncertain whether any systemic or topical treatments used to reduce bleeding due to major vascular surgery have an effect on: all-cause mortality up to 30 days; risk of requiring a repeat procedure or operation due to bleeding; number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. There may be no effect of tranexamic acid on the risk of thromboembolic events up to 30 days, this is important as there has been concern that this risk may be increased. Trials with sample size targets of thousands of participants and clinically relevant outcomes are needed, and we look forward to seeing the results of the ongoing trials in the future.
Topics: Adult; Humans; Aprotinin; Blood Transfusion; Deamino Arginine Vasopressin; Fibrin Tissue Adhesive; Hemorrhage; Network Meta-Analysis; Tranexamic Acid
PubMed: 36800489
DOI: 10.1002/14651858.CD013649.pub2 -
Langenbeck's Archives of Surgery Aug 2023Most studies on minimally invasive pancreatoduodenectomy (MIPD) combine patients with pancreatic and periampullary cancers even though there is substantial heterogeneity... (Meta-Analysis)
Meta-Analysis Review
The clinical implication of minimally invasive versus open pancreatoduodenectomy for non-pancreatic periampullary cancer: a systematic review and individual patient data meta-analysis.
BACKGROUND
Most studies on minimally invasive pancreatoduodenectomy (MIPD) combine patients with pancreatic and periampullary cancers even though there is substantial heterogeneity between these tumors. Therefore, this study aimed to evaluate the role of MIPD compared to open pancreatoduodenectomy (OPD) in patients with non-pancreatic periampullary cancer (NPPC).
METHODS
A systematic review of Pubmed, Embase, and Cochrane databases was performed by two independent reviewers to identify studies comparing MIPD and OPD for NPPC (ampullary, distal cholangio, and duodenal adenocarcinoma) (01/2015-12/2021). Individual patient data were required from all identified studies. Primary outcomes were (90-day) mortality, and major morbidity (Clavien-Dindo 3a-5). Secondary outcomes were postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), blood-loss, length of hospital stay (LOS), and overall survival (OS).
RESULTS
Overall, 16 studies with 1949 patients were included, combining 928 patients with ampullary, 526 with distal cholangio, and 461 with duodenal cancer. In total, 902 (46.3%) patients underwent MIPD, and 1047 (53.7%) patients underwent OPD. The rates of 90-day mortality, major morbidity, POPF, DGE, PPH, blood-loss, and length of hospital stay did not differ between MIPD and OPD. Operation time was 67 min longer in the MIPD group (P = 0.009). A decrease in DFS for ampullary (HR 2.27, P = 0.019) and distal cholangio (HR 1.84, P = 0.025) cancer, as well as a decrease in OS for distal cholangio (HR 1.71, P = 0.045) and duodenal cancer (HR 4.59, P < 0.001) was found in the MIPD group.
CONCLUSIONS
This individual patient data meta-analysis of MIPD versus OPD in patients with NPPC suggests that MIPD is not inferior in terms of short-term morbidity and mortality. Several major limitations in long-term data highlight a research gap that should be studied in prospective maintained international registries or randomized studies for ampullary, distal cholangio, and duodenum cancer separately.
PROTOCOL REGISTRATION
PROSPERO (CRD42021277495) on the 25th of October 2021.
Topics: Humans; Pancreaticoduodenectomy; Duodenal Neoplasms; Prospective Studies; Pancreas; Postoperative Complications; Laparoscopy; Pancreatic Neoplasms; Retrospective Studies
PubMed: 37581763
DOI: 10.1007/s00423-023-03047-4 -
HPB : the Official Journal of the... May 2022Major abdominal surgery and malignancy lead to a hypercoagulable state, with a risk of venous thromboembolism (VTE) of approximately 3% after pancreatic surgery. No... (Review)
Review
BACKGROUND
Major abdominal surgery and malignancy lead to a hypercoagulable state, with a risk of venous thromboembolism (VTE) of approximately 3% after pancreatic surgery. No guidelines exist to assist surgeons in managing VTE prophylaxis or anticoagulation in patients undergoing elective pancreatic surgery for malignancy or premalignant lesions. A systematic review specific to VTE prophylaxis and anticoagulation after resectional pancreatic surgery is herein provided.
METHODS
Six topic areas are reviewed: pre- and perioperative VTE prophylaxis, early postoperative VTE prophylaxis, extended outpatient VTE prophylaxis, management of chronic anticoagulation, anti-coagulation after vascular reconstruction, and treatment of VTE. A Medline and PubMED search was completed with systematic medical literature review for each topic. Level of evidence was graded and strength of recommendation ranked according to the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system for practice guidelines.
RESULTS
Levels of evidence and strength of recommendations are presented.
DISCUSSION
While strong data exist to guide management of chronic anticoagulation and treatment of VTE, data for anticoagulation after reconstruction is inconclusive and support for perioperative chemoprophylaxis with pancreatic surgery is similarly limited. The risk of post-pancreatectomy hemorrhage often exceeds that of thrombosis. The role of universal chemoprophylaxis must therefore be examined critically, particularly in the preoperative setting.
Topics: Anticoagulants; Blood Coagulation; Hemorrhage; Humans; Neoplasms; Risk Factors; Venous Thromboembolism
PubMed: 35063354
DOI: 10.1016/j.hpb.2021.12.010