Prehabilitation for general surgery: a systematic review of randomized controlled trials

Background

Prehabilitation seeks to optimize patient health before surgery to improve outcomes. Randomized controlled trials (RCTs) have been conducted on prehabilitation, however an updated synthesis of this evidence is required across General Surgery to inform potential Supplementary discipline-level protocols. Accordingly, this systematic review of RCTs aimed to evaluate the use of prehabilitation interventions across the discipline of General Surgery.

Methods

This study was registered with PROSPERO (CRD42023403289), and adhered to PRISMA 2020 and SWiM guidelines. PubMed/MEDLINE and Ovid Embase were searched to 4 March 2023 for RCTs evaluating prehabilitation interventions within the discipline of General Surgery. After data extraction, risk of bias was assessed using the Cochrane RoB 2 tool. Quantitative and qualitative data were synthesized and analysed. However, meta-analysis was precluded due to heterogeneity across included studies.

Results

From 929 records, 36 RCTs of mostly low risk of bias were included. 17 (47.2%) were from Europe, and 14 (38.9%) North America. 30 (83.3%) investigated cancer populations. 31 (86.1%) investigated physical interventions, finding no significant difference in 16 (51.6%) and significant improvement in 14 (45.2%). Nine (25%) investigated psychological interventions: six (66.7%) found significant improvement, three (33.3%) found no significant difference. Five (13.9%) investigated nutritional interventions, finding no significant difference in three (60%), and significant improvement in two (40%).

Conclusions

Prehabilitation interventions showed mixed levels of effectiveness, and there is insufficient RCT evidence to suggest system-level delivery across General Surgery within standardized protocols. However, given potential benefits and non-inferiority to standard care, they should be considered on a case-by-case basis.     

Aprotinin in major orthopedic surgery: a systematic review of randomized controlled trials

Aprotinin therapy is a promising strategy for reducing blood loss and blood transfusion requirements. The efficacy and safety of aprotinin in orthopedic surgery, however, remain controversial. We searched electronic databases for randomized controlled trials on the efficacy and safety of the use of aprotinin in orthopedic surgery. Thirteen trials that included a total of 506 patients who underwent major orthopedic surgery were analyzed. The pooled intraoperative and perioperative blood loss was significantly less in the aprotinin-treated patients than in the control patients (weighted mean difference [WMD] for intraoperative blood loss = -229 mL, 95% confidence interval [CI] = -367 to -91 mL, P = 0.0011; WMD for perioperative blood loss = -557 mL; 95% CI = -860 to -254 mL; P < 0.0001). The pooled amounts of red blood cell (RBC) units (U) transfused intraoperatively and perioperatively were significantly less in the aprotinin-treated patients than in the control patients (WMD for intraoperative RBC U = -1.1 U; 95% CI = -1.7 to -0.4 U; P = 0.0001; WMD for perioperative RBC U = -1.1 U; 95% CI = -1.7 to -0.5 U; P < 0.0001). Aprotinin was not associated with an increased incidence of deep vein thrombosis (odds ratio = 0.39; 95% CI = 0.14 to 1.05, P = 0.061). The authors conclude that aprotinin reduces the intraoperative and perioperative blood loss and allogeneic blood transfusion requirement and may not be associated with increased risk of deep vein thrombosis in the presence of pharmacological or mechanical prophylaxis in patients undergoing major orthopedic surgery.     

胃肠手术后肠内/肠外营养临床对照研究的荟萃分析

目的 分析国内外相关文献资料,比较肠内营养(EN)、肠外营养(PN)对胃肠手术患者预后的影响,探讨胃肠术后早期应用EN的合理性.方法 检索PubMed、EMBASE和Cochrane图书馆数据库,对1970年至2008年中胃肠手术后给予EN、PN相关的临床随机对照试验进行荟萃分析.评价终止的指标包括吻合口裂开、感染(包括导管脓毒症、伤口感染、肺炎、腹腔脓肿、泌尿系感染)、呕吐及腹胀、其他并发症、住院天数和病死率.结果 23组临床随机实验共2784例患者符合录入标准.与PN组比较,EN可减少吻合口裂开(RR=0.67,95%Cl:0.50～0.91;P=0.010)、感染(RR=0.72,95%CI:0.64～0.81;P<0.001),其他并发症(RR=0.82,95%CI:0.73～0.92;P<0.001)和住院的时间(加权均数差值=-3.60;95% CI:-3.88～-3.32;P<0.001).但EN组腹胀和呕吐的不良反应更多见(RR=1.39,95%CI:1.21～1.59;P<0.001).两组病死率比较差异无统计学意义(P=0.400).结论 胃肠手术后患者没有"禁食水"的必要,早期给予EN辅助治疗,有利于促进患者恢复,减少并发症的发生.     

Quality of assessment of randomized controlled trials in blood conservation after joint arthroplasty

Blood transfusion after joint arthroplasty occurs in up to two thirds of patients. We conducted a systematic review of the literature to determine the methodological quality of published randomized controlled trials (RCTs). We searched MEDLINE, EMBASE, and Cochrane to identify RCTs in arthroplasty with blood conservation as the primary outcome from 2001 to 2007. Methodological quality was evaluated using the Detsky index. We identified 62 RCTs. The mean Detsky score was 73% ± 14%. Epidemiology affiliation (P = .003), funding support (<.001), and year of publication (<.001) were the predictors of reporting quality, predicting 46% of the variability (R² = 0.46). This suggests poor reporting quality of trials in blood conservation. The inclusion of an epidemiologist or a biostatistician for the design of a trial is strongly recommended.     

Comparison of effects in randomized controlled trials with observational studies in digestive surgery

OBJECTIVES: To compare the results of randomized controlled trials versus observational studies in meta-analyses of digestive surgical topics. SUMMARY BACKGROUND DATA: While randomized controlled trials have been recognized as providing the highest standard of evidence, claims have been made that observational studies may overestimate treatment benefits. This debate has recently been renewed, particularly with regard to pharmacotherapies. METHODS: The PubMed (1966 to April 2004), EMBASE (1986 to April 2004) and Cochrane databases (Issue 2, 2004) were searched to identify meta-analyses of randomized controlled trials in digestive surgery. Fifty-two outcomes of 18 topics were identified from 276 original articles (96 randomized trials, 180 observational studies) and included in meta-analyses. All available binary data and study characteristics were extracted and combined separately for randomized and observational studies. In each selected digestive surgical topic, summary odds ratios or relative risks from randomized controlled trials were compared with observational studies using an equivalent calculation method. RESULTS: Significant between-study heterogeneity was seen more often among observational studies (5 of 12 topics) than among randomized trials (1 of 9 topics). In 4 of the 16 primary outcomes compared (10 of 52 total outcomes), summary estimates of treatment effects showed significant discrepancies between the two designs. CONCLUSIONS: One fourth of observational studies gave different results than randomized trials, and between-study heterogeneity was more common in observational studies in the field of digestive surgery.     

A primer on randomized controlled trials

Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.     

围手术期目标导向容量治疗用于预防腹部手术后胃肠道并发症的Meta分析

目的 评价围术期目标导向容量治疗对预防腹部手术后胃肠道并发症的有效性,为制定临床合理的个体化容量治疗方案提供理论依据.方法 计算机检索Cochrane图书馆(2010年第3期)、PubMed、EMbase、Highwire、CBM、CNKI等中外生物医学数据库.收集关于围手术期目标导向容量治疗对预防腹部手术后胃肠道并发症方面的临床随机对照试验,检索日期由2000年1月至2010年12月.按Cochrane系统评价方法,评价所纳入研究的文献质量,并提取有效数据后采用RevMan5.0软件进行Meta分析.结果 纳入10项研究,共计775例患者.Meta结果 显示:目标导向容量治疗可显著提高机体氧供(WMD=82.95,95%CI:17.43～148.46),降低胃肠道术后并发症的发生率(RR=0.39,95%CI:0.29～0.52),并缩短住院天数(WMD=-2.06,95%CI:-2.95～-1.17).结论 围手术期目标导向容量治疗可以有效预防术后胃肠道并发症的发生.

Abstract：

Objective To assess whether goal-directed fluid management can prevent gastrointestinal complications in major surgery. Methods Electronic databases including Cochrane library (Issue 3,2010), Pubmed, EMbase, Highwire, CBM, and CNKI were searched. The date of search was between January 2000 and December 2010. Randomized controlled trials (RCTs) were indentified studying association of goal-directed therapy (GDT) with gastrointestinal complications. Study selection and meta-analysis were conducted according to the Cochrane Handbook for systematic reviews. Data were extracted from these trials by 3 reviewers independently and analyzed by RevMan5.0 software. Results Ten trials involving 775 patients were included. GDT significantly improved oxygen supply (WMD=82.95, 95% CI: 17.43-148.46). GDT reduced postoperative hospital stay (WMD=-2.06, 95% CI:-2.95——1.17) and decreased postoperative complication rate after major surgery(RR=0.39, 95% CI: 0.29-0.52). Conclusion Goal-directed fluid management can stabilize cardiac output, augment oxygen supply, and therefore reduce postoperative complications.     

Centrifugal pump and roller pump in adult cardiac surgery: a meta-analysis of randomized controlled trials

Centrifugal pump (CP) and roller pump (RP) designs are the dominant main arterial pumps used in cardiopulmonary bypass (CPB). Trials reporting clinical outcome measures comparing CP and RP are controversial. Therefore, a meta‐analysis was undertaken to evaluate clinical variables from randomized controlled trials (RCTs). Keyword searches were performed on Medline (1966–2011), EmBase (1980–2011), and CINAHL (1981–2011) for studies comparing RP and CP as the main arterial pump in adult CPB. Pooled fixed‐effects estimates for dichotomous and continuous data were calculated as an odds ratio and weighted‐mean difference, respectively. The P value was utilized to assess statistical significance (P < 0.05) between CP and RP groups. Eighteen RCTs met inclusion criteria, which represented 1868 patients (CP = 961, RP = 907). The prevailing operation was isolated coronary artery bypass graft surgery (CP = 88%, RP = 87%). Fixed‐effects pooled estimates were performed for end‐of‐CPB (ECP) and postoperative day one (PDO) for platelet count (ECP: P = 0.51, PDO: P = 0.16), plasma free hemoglobin (ECP: P = 0.36, PDO: P = 0.24), white blood cell count (ECP: P = 0.21, PDO: P = 0.66), and hematocrit (ECP: P = 0.06, PDO: P = 0.51). No difference was demonstrated for postoperative blood loss (P = 0.65) or red blood cell transfusion (P = 0.71). Intensive care unit length of stay (P = 0.30), hospital length of stay (P = 0.33), and mortality (P = 0.91) were similar between the CP and RP groups. Neurologic outcomes were not amenable to pooled analysis; nevertheless, the results were inconclusive. There was no reported pump‐related malfunction or mishap. The meta‐analysis of RCTs comparing CP and RP in adult cardiac surgery suggests no significant difference for hematological variables, postoperative blood loss, transfusions, neurological outcomes, or mortality.     

Trends in endoscopic surgery for inguinal hernia: collective review of meta-analyses and randomized controlled trials

Inguinal hernia repair is one of the most commonly performed general surgical procedures and endoscopic herniorrhaphy has been performed around the world. We review the meta-analysis and recent large randomized controlled trials of endoscopic versus open repairs for inguinal hernia. Currently available evidence shows that endoscopic herniorrhaphy, when compared with open herniorrhapy, is associated with less persisting pain and numbness, earlier return to normal activity, and a lower risk of hematoma and wound infection, but this technique takes longer and has more serious complications. Hernia recurrence is comparable to open mesh methods and less common than after open non-mesh methods. More carefully conceived and executed studies are needed to establish the future role of endoscopic surgery for inguinal hernia repair.     

Emerging designs in orthopaedics: expertise-based randomized controlled trials

In this article, we discuss the limitations of conventional randomized controlled trials (RCTs) in the surgical field. Surgeons are often believers in certain surgical techniques and therefore can be reluctant to learn new interventions. In expertise-based trials, the patients are randomized to surgeons with expertise in the intervention under investigation. In conventional RCTs, patients are randomized to an intervention, and surgeons will perform this intervention regardless of whether this is the surgery they typically undertake. Conventional randomization may lead to surgery performed by a less experienced or less motivated surgeon, resulting in differential expertise bias. Expertise-based trials can overcome these limitations if potential pitfalls are taken into account.