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The American Surgeon Dec 2023There is no level 1a evidence testing quilting suture (QS) technique after mastectomy on wound outcomes. The aim of this systematic review and meta-analysis evaluates QS... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There is no level 1a evidence testing quilting suture (QS) technique after mastectomy on wound outcomes. The aim of this systematic review and meta-analysis evaluates QS and association with surgical site occurrences as compared to conventional closure (CC) for mastectomy.
METHODS
MEDLINE, PubMed, and Cochrane Library were systematically searched to include adult women with breast cancer undergoing mastectomy. The primary endpoint was postoperative seroma rate. Secondary endpoints included rates of hematoma, surgical site infection (SSI), and flap necrosis. The Mantel-Haenszel method with random-effects model was used for meta-analysis. Number needed to treat was calculated to assess clinical relevance of statistical findings.
RESULTS
Thirteen studies totaling 1748 patients (870 QS and 878 CC) were included. Seroma rates were statistically significantly lower in patients with QS (OR [95%CI] = .32 [.18, .57]; < .0001) than CC. Hematoma rates (OR [95%CI] = 1.07 [.52, 2.20]; = .85), SSI rates (OR [95%CI] = .93 [.61, 1.41]; = .73), and flap necrosis rates (OR [95%CI] = .61 [.30, 1.23]; = .17) did not significantly vary between QS and CC.
CONCLUSION
This meta-analysis found that QS was associated with significantly decreased seroma rates when compared to CC in patients undergoing mastectomy for cancer. However, improvement in seroma rates did not translate into a difference in hematoma, SSI, or flap necrosis rates.
Topics: Adult; Humans; Female; Mastectomy; Breast Neoplasms; Seroma; Surgical Flaps; Drainage; Surgical Wound Infection; Suture Techniques; Hematoma; Necrosis; Postoperative Complications
PubMed: 37144600
DOI: 10.1177/00031348231173995 -
Clinical and Translational... Nov 2023Phase 2 trials are fundamental to the rational and efficient design of phase 3 trials. We aimed to determine the relationship of treatment effect size estimates from... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Phase 2 trials are fundamental to the rational and efficient design of phase 3 trials. We aimed to determine the relationship of treatment effect size estimates from phase 2 and phase 3 clinical trials on advanced therapeutics in inflammatory bowel disease.
METHODS
MEDLINE, EMBASE, CENTRAL, and the Cochrane library were searched from inception to December 19, 2022, to identify paired phase 2 and 3 placebo-controlled induction studies of advanced therapeutics for Crohn's disease (CD) and ulcerative colitis (UC). Treatment effect sizes were expressed as a risk ratio (RR) between the active arm and placebo arm. For the same therapeutics, RRs from phase 2 trials were divided by the RR from phase 3 trial to quantify the relationship of effect sizes between phases.
RESULTS
Twenty-two studies (9 phase 2 trials, 13 phase 3 trials) were included for CD and 30 studies (12 phase 2 trials, 18 phase 3 trials) for UC. In UC (pooled RR 0.72; 95% confidence interval: 0.58-0.86; RR <1 indicates smaller treatment effect sizes in phase 2 trials), but not CD (pooled RR 1.01; 95% confidence interval: 0.84-1.18), phase 2 trials systematically underestimated treatment effect sizes for the primary endpoint compared with phase 3 trials. The underestimation was observed for clinical, but not endoscopic, endpoints in UC.
DISCUSSION
Treatment effect sizes for the primary and clinical endpoints were similar across clinical trial phases in CD, but not UC, where only endoscopic endpoints were comparable. This will help inform clinical development plans and future trial design.
Topics: Humans; Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Remission Induction; Induction Chemotherapy; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic
PubMed: 37578211
DOI: 10.14309/ctg.0000000000000629 -
BMC Pediatrics Feb 2018The World Health Organization (WHO) recommends rapid intravenous rehydration, using fluid volumes of 70-100mls/kg over 3-6 h, with some of the initial volume given... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The World Health Organization (WHO) recommends rapid intravenous rehydration, using fluid volumes of 70-100mls/kg over 3-6 h, with some of the initial volume given rapidly as initial fluid boluses to treat hypovolaemic shock for children with acute gastroenteritis (AGE) and severe dehydration. The evidence supporting the safety and efficacy of rapid versus slower rehydration remains uncertain.
METHODS
We conducted a systematic review of randomised controlled trials (RCTs) on 11th of May 2017 comparing different rates of intravenous fluid therapy in children with AGE and moderate or severe dehydration, using standard search terms. Two authors independently assessed trial quality and extracted data. Non-RCTs and non-English articles were excluded. The primary endpoint was mortality and secondary endpoints included adverse events (safety) and treatment efficacy.
MAIN RESULTS
Of the 1390 studies initially identified, 18 were assessed for eligibility. Of these, 3 studies (n = 464) fulfilled a priori criteria for inclusion; most studied children with moderate dehydration and none were conducted in resource-poor settings. Volumes and rates of fluid replacement varied from 20 to 60 ml/kg given over 1-2 h (fast) versus 2-4 h (slow). There was substantial heterogeneity in methodology between the studies with only one adjudicated to be of high quality. There were no deaths in any study. Safety endpoints only identified oedema (n = 6) and dysnatraemia (n = 2). Pooled analysis showed no significant difference between the rapid and slow intravenous rehydration groups for the proportion of treatment failures (N = 468): pooled RR 1.30 (95% CI: 0.87, 1.93) and the readmission rates (N = 439): pooled RR 1.39 (95% CI: 0.68, 2.85).
CONCLUSIONS
Despite wide implementation of WHO Plan C guideline for severe AGE, we found no clinical evaluation in resource-limited settings, and only limited evaluation of the rate and volume of rehydration in other parts of the world. Recent concerns over aggressive fluid expansion warrants further research to inform guidelines on rates of intravenous rehydration therapy for severe AGE.
Topics: Acute Disease; Adolescent; Child; Child, Preschool; Dehydration; Fluid Therapy; Gastroenteritis; Humans; Infant; Infant, Newborn; Infusions, Intravenous; Randomized Controlled Trials as Topic; Risk; Time Factors; Treatment Outcome
PubMed: 29426307
DOI: 10.1186/s12887-018-1006-1 -
Cardiology 2022There have been inconsistent data on the direct comparison of prasugrel and ticagrelor. This meta-analysis was conducted to summarize the current available evidence. (Meta-Analysis)
Meta-Analysis
INTRODUCTION
There have been inconsistent data on the direct comparison of prasugrel and ticagrelor. This meta-analysis was conducted to summarize the current available evidence.
METHODS
We performed a meta-analysis (PROSPERO-registered CRD42020166810) of randomized trials up to February 2020 that compared prasugrel and ticagrelor in acute coronary syndrome with respect to the composite endpoint of myocardial infarction (MI), stroke, or cardiovascular death and secondary endpoints including MI, stroke, cardiovascular death, major bleeding (Bleeding Academic Research Consortium (BARC) type 2 or above), stent thrombosis, all-cause death, and other safety outcomes.
RESULTS
Of the 11 eligible RCTs with 6,098 patients randomized to prasugrel (n = 3,050) or ticagrelor (n = 3,048), 180 and 207 had the composite endpoint events in the prasugrel arm and the ticagrelor arm, respectively, over a weighted mean follow-up period of 11 ± 2 months. Compared with prasugrel, the ticagrelor group had similar risk in the primary composite endpoint (risk ratio [RR] = 1.17; 95% CI = 0.96-1.42; p = 0.12, I2 = 0%). Compared to prasugrel, there was no significant difference associated with the ticagrelor groups with respect to stroke (RR = 1.05; 95% CI = 0.66-1.67; p = 0.84, I2 = 0%), cardiovascular death (RR = 1.01; 95% CI = 0.75-1.36; p = 0.95, I2 = 0%), BARC type 2 or above bleeding (RR = 1.16; 95% CI = 0.89-1.52; p = 0.26, I2 = 0%), stent thrombosis (RR = 1.58; 95% CI = 0.90-2.76; p = 0.11, I2 = 0%), and all-cause death (RR = 1.10; 95% CI = 0.86-1.43; p = 0.45, I2 = 0%) except MI (RR = 1.38; 95% CI = 1.05-1.81; p = 0.02, I2 = 0%) Conclusion: Compared with prasugrel, ticagrelor did not reduce the primary composite endpoint of MI, stroke, and cardiovascular death at a weighted mean follow-up of 11 months. There was no significant difference between the secondary outcomes except MI.
Topics: Acute Coronary Syndrome; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Randomized Controlled Trials as Topic; Ticagrelor; Treatment Outcome
PubMed: 34743081
DOI: 10.1159/000520673 -
HPB : the Official Journal of the... Jun 2023Spleen preserving distal pancreatectomy (SPDP) represents a widely adopted procedure in the presence of benign or low-grade malignant tumors. Splenic vessels... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Spleen preserving distal pancreatectomy (SPDP) represents a widely adopted procedure in the presence of benign or low-grade malignant tumors. Splenic vessels preservation and resection (Kimura and Warshaw techniques respectively) represent the two main surgical modalities to avoid splenic resection. Each one is characterized by strengths and drawbacks. The aim of the present study is to systematically review the current high-quality evidence regarding these two techniques and analyze their short-term outcomes.
METHODS
A systematic review was conducted according to PRISMA, AMSTAR II and MOOSE guidelines. The primary endpoint was to assess the incidence of splenic infarction and splenic infarction leading to splenectomy. As secondary endpoints, specific intraoperative variables and postoperative complications were explored. Metaregression analysis was conducted to evaluate the effect of general variables on specific outcomes.
RESULTS
Seventeen high-quality studies were included in quantitative analysis. A significantly lower risk of splenic infarction for patients undergoing Kimura SPDP (OR = 0.14; p < 0.0001). Similarly, splenic vessel preservation was associated with a reduced risk of gastric varices (OR = 0.1; 95% p < 0.0001). Regarding all secondary outcome variables, no differences between the two techniques were noticed. Metaregression analysis failed to identify independent predictors of splenic infarction, blood loss, and operative time among general variables.
CONCLUSIONS
Although Kimura and Warshaw SPDP have been demonstrated comparable for most of postoperative outcomes, the former resulted superior compared to the latter in reducing the risk of splenic infarction and gastric varices. For benign pancreatic tumors and low-grade malignancies Kimura SPDP may be preferred.
Topics: Humans; Esophageal and Gastric Varices; Pancreatectomy; Pancreatic Neoplasms; Postoperative Complications; Retrospective Studies; Splenic Artery; Splenic Infarction; Treatment Outcome
PubMed: 36941150
DOI: 10.1016/j.hpb.2023.02.009 -
BMJ Open Jun 2017To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone.
DESIGN AND SETTING
Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale.
INTERVENTIONS
Capnography monitoring relative to visual assessment and pulse oximetry alone.
PRIMARY AND SECONDARY OUTCOME MEASURES
Predefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA.
RESULTS
The literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95% CI 0.67 to 0.89) and severe (RR 0.59, 95% CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95% CI 0.23 to 0.95). No significant differences in other endpoints were identified.
CONCLUSIONS
Meta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation.
Topics: Bradycardia; Capnography; Conscious Sedation; Deep Sedation; Humans; Monitoring, Physiologic; Oximetry; Patient Safety; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Insufficiency
PubMed: 28667196
DOI: 10.1136/bmjopen-2016-013402 -
Journal of Cardiovascular... May 2023Intravenous magnesium (IV Mg), a commonly utilized therapeutic agent in the management of atrial fibrillation (AF) with rapid ventricular response, is thought to exert... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intravenous magnesium (IV Mg), a commonly utilized therapeutic agent in the management of atrial fibrillation (AF) with rapid ventricular response, is thought to exert its influence via its effect on cellular automaticity and prolongation of atrial and atrioventricular nodal refractoriness thus reducing ventricular rate. We sought to undertake a systematic review and meta-analysis of the effectiveness of IV Mg versus placebo in addition to standard pharmacotherapy in the rate and rhythm control of AF in the nonpostoperative patient cohort given that randomized control trials (RCTs) have shown conflicting results.
METHODS
Randomized controlled trials comparing IV Mg versus placebo in addition to standard of care were identified via electronic database searches. Nine RCTs were returned with a total of 1048 patients. Primary efficacy endpoints were study-defined rate control and rhythm control/reversion to sinus rhythm. The secondary endpoint was patient experienced side effects.
RESULTS
Our analysis found IV Mg in addition to standard care was successful in achieving rate control (odd ratio [OR] 1.87, 95% confidence interval [CI] 1.13-3.11, p = .02) and rhythm control (OR 1.45, 95% CI 1.04-2.03, p = .03). Although not well reported among studies, there was no significant difference between groups regarding the likelihood of experiencing side effects.
CONCLUSIONS
IV Mg, in addition to standard-of-care pharmacotherapy, increases the rates of successful rate and rhythm control in nonpostoperative patients with AF with rapid ventricular response and is well tolerated.
Topics: Humans; Atrial Fibrillation; Anti-Arrhythmia Agents; Magnesium; Administration, Intravenous; Heart Ventricles
PubMed: 37186322
DOI: 10.1111/jce.15911 -
Techniques in Coloproctology Feb 2023The aim of this study was to summarize the current evidence regarding the role of the Rafaelo procedure in the management of hemorrhoidal disease (HD). (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of this study was to summarize the current evidence regarding the role of the Rafaelo procedure in the management of hemorrhoidal disease (HD).
METHODS
This study was based on the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A literature search was performed (Medline, Scopus, CENTRAL, and Web of Science) from inception to 25/09/2022. Grey literature databases were also reviewed. The primary endpoint was the pooled complications rate of the Rafaelo procedure in patients with HD. Secondary endpoints included short- (bleeding, pain, thrombosis, necrosis, urinary retention, fever, oedema, anal fissure, and readmission) and long-term (stenosis, meteorism, constipation, anal tags, anal hyposensibility, reoperation, and recurrence) postoperative complication rates. Both prospective and retrospective studies were considered. Quality evaluation was performed via the ROBINS-I tool. Certainty of Evidence was based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology.
RESULTS
Overall, 6 non-randomized studies and 327 patients were included. The overall complication rate was 17.6% (95% CI 8.8-26.3%). Short-term complications were bleeding (7.5%, 95% CI 2.5-12.5%), thrombosis (2.2%, 95% CI 0.4-4.8%), and pain (1.6%, 95% CI 0.2-3.3%). Reoperation and recurrence rates were 1.8% (95% CI 0.3-3.4%) and 4.8% (95% CI 1.2-8.4%), respectively. A significant improvement in the presenting symptoms was noted. Method approval and patient satisfaction rates were 89.1% (95% CI 81.7-96.6%) and 95% (95% CI 89.8-100%), correspondingly. Overall CoE was "Very Low".
CONCLUSIONS
Further randomized controlled trials are required to delineate the exact role of the Rafaelo procedure in HD.
Topics: Humans; Hemorrhoids; Retrospective Studies; Prospective Studies; Neoplasm Recurrence, Local; Pain
PubMed: 36371772
DOI: 10.1007/s10151-022-02730-w -
The impact of enhanced recovery after gynaecological surgery: A systematic review and meta-analysis.Gynecologic Oncology Jan 2023Enhanced Recovery After Surgery programs have become the gold standard of care in many surgical specialities. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Enhanced Recovery After Surgery programs have become the gold standard of care in many surgical specialities.
OBJECTIVES
This updated systematic review and meta-analysis aims to evaluate how an ERAS program can impact outcomes across both benign and oncological gynaecological surgery to inform standard surgical practice.
SEARCH STRATEGY
An electronic search of the SCOPUS, Embase and PubMed Medline databases was performed for relevant studies assessing the use of ERAS in patients undergoing gynaecological surgery compared with those without ERAS.
SELECTION CRITERIA
The studies included were all trials using ERAS programs in gynaecological surgery with a clearly outlined protocol which included at least four items from the most recent guidelines and recorded one primary outcome.
DATA COLLECTION AND ANALYSIS
Meta-analysis was performed on two primary endpoints; post-operative length of stay and readmission rate and one secondary endpoint; rates of ileus. Further subgroup analyses was performed to compare benign and oncological surgeries.
MAIN RESULTS
Forty studies (7885 patients) were included in the meta-analysis; 15 randomised controlled trials and 25 cohort studies. 21 studies (4333 patients) were included in meta-analyses of length of stay. Patients in the ERAS group (2351 patients) had a shortened length of stay by 1.22 days (95% CI: -1.59 - -0.86, P < 0.00001) compared to those in the control group (1982 patients). Evaluation of 27 studies (6051 patients) in meta-analysis of readmission rate demonstrated a 20% reduction in readmission rate (OR: 0.80, 95% CI: 0.65-0.97). Analysis of our secondary outcome, demonstrated a 47% reduction in rate of ileus compared to the control group.
CONCLUSIONS
ERAS pathways significantly reduce length of stay without increasing readmission rates or rates of ileus across benign and oncological gynaecological surgery.
Topics: Female; Humans; Postoperative Complications; Gynecologic Surgical Procedures; Ileus; Length of Stay; Postoperative Period
PubMed: 36356373
DOI: 10.1016/j.ygyno.2022.10.019 -
Infectious Diseases Now Aug 2023Fever contributes to the inflammatory response; in some infections, antipyretics could prolong the illness. The objective of our study was to evaluate the impact of... (Review)
Review
Does the use of antipyretics prolong illness? A systematic review of the literature and meta-analysis on the effects of antipyretics in acute upper and lower respiratory tract infections.
OBJECTIVE
Fever contributes to the inflammatory response; in some infections, antipyretics could prolong the illness. The objective of our study was to evaluate the impact of antipyretic treatments on the evolution of acute upper and lower respiratory tract infections (RTI).
METHOD
A systematic literature review of randomized controlled trials (RCTs) with meta-analysis was conducted. Our primary endpoint was the time to recovery from illness. Our prespecified secondary endpoints were quality of life, duration and number of fever episodes, repeated medical visits, and adverse events.
RESULTS
Out of the 1466 references found, 25 RCTs were included. There were two studies assessing mean fever clearance time, and five studies examining the duration of symptoms associated with the illness studied. No statistically significant differences were found when pooling the results of the different studies. The assessment of adverse events showed a significant difference disadvantaging non-steroidal anti-inflammatory drugs. No meta-analysis could be performed for our other secondary endpoints. The quality of the evidence is limited by the small number of studies included for our primary endpoint and by heterogeneity between the studies.
CONCLUSION
Our results suggest that the use of antipyretics does not prolong or shorten illness duration in acute upper and lower RTI. The symptomatic efficacy of antipyretics must be weighed against their adverse effects, particularly when fever is well-tolerated.
Topics: Humans; Antipyretics; Respiratory Tract Infections; Fever; Anti-Bacterial Agents
PubMed: 37142229
DOI: 10.1016/j.idnow.2023.104716