•Fragility index: number of events to change a significant outcome to non-significant.•We applied the fragility index to total neoadjuvant therapy for rectal cancer trials.•Ten trials were identified ...with 25 statistically significant outcomes.•The median fragility index was 2 (interquartile range 1–16)•The loss to follow-up exceeded the fragility index in 68.0% of outcomes.
Recently, there has been significant interest in, and adoption of, total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC). We designed the present study to assess the robustness of the randomized controlled trials (RCTs) evaluating contemporary TNTs for LARC using the fragility index (FI).
Relevant articles were identified through a review article by Johnson et al. in the Canadian Journal of Surgery. Dichotomous outcomes within these RCTs were eligible for inclusion if the reported effect size had a p-value < 0.05. The main outcome was FI for each included outcome. Walsh et al.’s method of calculating FI was utilized. Correlations between FI and research characteristics were assessed using the Spearman’s rank correlation coefficients. Risk of bias was assessed using Cochrane recommended tools.
Ten RCTs were identified with 25 outcomes having statistically significant differences between groups. Eleven outcomes were time-to-event outcomes, while the remainder were dichotomous outcomes. Approximately half (n = 13) were oncologic outcomes. The median FI was 2 (interquartile range IQR 1–16). The number of patients lost to follow-up exceeded the FI in 17 outcomes (68.0 %) and thus these results were considered “fragile”. Lower FI was associated with high risk of bias (rho = −0.5594) and greater loss to follow-up (rho = −0.4394), while higher FI was associated with large study size (rho = 0.5120).
The robustness of outcomes from trials assessing TNT for LARC was found to be questionable. Most outcomes were fragile, as determined by the FI. This survey is limited by the number of included studies.
Summary Background Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation ...exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). Methods We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. Findings Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference WMD, fixed effect: 1·04 min, 95% CI 0·84–1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96–1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm2 , 95% CI −0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm2 , 95% CI 0·08–1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 μSv (SD 110) with transradial access and 74 μSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 μSv (17) with transradial access and 46 μSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs. Interpretation Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. Funding None.
Does surgery or conservative management of recurring diverticulitis/ongoing symptoms results in a higher quality of life (QoL) at 5-year follow-up.
Randomized controlled trial.
Multicenter trial in ...the Netherlands.
Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study.
Elective Sigmoid Resection within 6 weeks vs. Conservative Management MAIN OUTCOME:: QoL at 5-year follow-up, as measured by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes included additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey) RESULTS:: The intention to treat analysis showed the surgical group had a higher quality of life (GIQLI) score than the conservative group (mean difference 9.7, 95% confidence interval 1.7-17.7, P = 0.018), which approached but did not meet the minimum important difference of 10. This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
The study results demonstrate that HRQOL at 5-year follow-up may be improved in patients undergoing surgical resection, although this difference did not meet the MID for the GIQLI.
Background
Surgical site infection (SSI) is a common complication in gastrointestinal surgery. Wound protection devices are being increasingly used in the attempt to reduce infection rates. We ...performed a meta-analysis to determine if wound protectors reduce the incidence of SSIs in lower gastrointestinal surgery.
Methods
MEDLINE and EMBASE databases were searched between 1946 and 2016. Randomized controlled trials comparing wound protector versus no wound protector in lower gastrointestinal surgery were included. Our primary outcome was surgical site infection. Subgroup analysis was conducted comparing single-ring versus dual-ring wound protectors.
Results
Twelve RCTs with 3029 participants were included. There was a significant decrease in the odds of developing SSI in the wound protector group (OR 0.64, 95% CI 0.45–0.90,
P
< 0.01,
I
2
= 55%). There was evidence of a subgroup effect (
P
= 0.01) with dual-ring wound protectors associated with significantly lower incidence of SSIs (OR 0.31, 95% CI 0.18–0.52,
P
< 0.0001,
I
2
= 12%), which was not appreciated in the single-ring group (OR 0.84, 95% CI 0.67–1.04,
P
= 0.11,
I
2
= 0%).
Conclusions
Wound protector use is associated with decreased odds of developing SSI in patients undergoing lower gastrointestinal surgery. There was a subgroup effect when comparing dual-ring to single-ring devices.
To assess the prevalence, magnitude, and disclosure status of industry funding in editorial boards of surgery journals.
Financial COI can bias research. Although authors seeking to publish in ...peer-reviewed surgery journals are required to provide COI disclosures, editorial board members' COI disclosures are generally not disclosed to readers.
We present a cross-sectional analysis of industry funding to editorial board members of high-impact surgery journals. We reviewed top US-based surgery journals by impact factor to determine the presence of financial COI in members of each journal's editorial board. The prevalence and magnitude of COI was determined using 2018 industry reported payments found in the Centers for Medicare and Medicaid Services Open Payments database. Journal websites were also reviewed looking for the presence of editorial board disclosure statements.
A total of 1002 names of editorial board members from the top 10 high-impact American surgery journals were identified. Of 688 individual physicians based in the USA, 452 (65.7%) were found to have received industry payments in 2018, totaling $21,916,503 with a median funding amount per physician of $1253 (interquartile range $156-$10,769). Funding levels varied by surgical specialty and journal. Editorial board disclosure information was found in only 3.3% of physicians.
Industry funding to editorial board members of high impact surgery journals is prevalent and underreported. Mechanisms of disclosure for COI are needed at the editorial board level to provide readers full transparency. This would acknowledge this COI of editorial board members, and thereby attempt to potentially further reduce the risk of bias in editorial decisions.
Surgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition, surgeons can choose to close ...the incision in anatomic layers or mass ('en masse'), as well as using either a continuous or interrupted suturing technique, of which there are different styles of each. There is ongoing debate as to which suturing techniques and suture materials are best for achieving definitive wound closure while minimising the risk of short- and long-term complications.
The objectives of this review were to identify the best available suture techniques and suture materials for closure of the fascia following laparotomy incisions, by assessing the following comparisons: absorbable versus non-absorbable sutures; mass versus layered closure; continuous versus interrupted closure techniques; monofilament versus multifilament sutures; and slow absorbable versus fast absorbable sutures. Our objective was not to determine the single best combination of suture material and techniques, but to compare the individual components of abdominal closure.
On 8 February 2017 we searched CENTRAL, MEDLINE, Embase, two trials registries, and Science Citation Index. There were no limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that our searches may have missed.
We included randomised controlled trials (RCTs) that compared suture materials or closure techniques, or both, for fascial closure of laparotomy incisions. We excluded trials that compared only types of skin closures, peritoneal closures or use of retention sutures.
We abstracted data and assessed the risk of bias for each trial. We calculated a summary risk ratio (RR) for the outcomes assessed in the review, all of which were dichotomous. We used random-effects modelling, based on the heterogeneity seen throughout the studies and analyses. We completed subgroup analysis planned a priori for each outcome, excluding studies where interventions being compared differed by more than one component, making it impossible to determine which variable impacted on the outcome, or the possibility of a synergistic effect. We completed sensitivity analysis, excluding trials with at least one trait with high risk of bias. We assessed the quality of evidence using the GRADEpro guidelines.
Fifty-five RCTs with a total of 19,174 participants met the inclusion criteria and were included in the meta-analysis. Included studies were heterogeneous in the type of sutures used, methods of closure and patient population. Many of the included studies reported multiple comparisons.For our primary outcome, the proportion of participants who developed incisional hernia at one year or more of follow-up, we did not find evidence that suture absorption (absorbable versus non-absorbable sutures, RR 1.07, 95% CI 0.86 to 1.32, moderate-quality evidence; or slow versus fast absorbable sutures, RR 0.81, 95% CI 0.63 to 1.06, moderate-quality evidence), closure method (mass versus layered, RR 1.92, 95% CI 0.58 to 6.35, very low-quality evidence) or closure technique (continuous versus interrupted, RR 1.01, 95% CI 0.76 to 1.35, moderate-quality evidence) resulted in a difference in the risk of incisional hernia. We did, however, find evidence to suggest that monofilament sutures reduced the risk of incisional hernia when compared with multifilament sutures (RR 0.76, 95% CI 0.59 to 0.98, I
= 30%, moderate-quality evidence).For our secondary outcomes, we found that none of the interventions reduced the risk of wound infection, whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.99, 95% CI 0.84 to 1.17, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.16, 95% CI 0.85 to 1.57, moderate-quality evidence), closure method (mass versus layered, RR 0.93, 95% CI 0.67 to 1.30, low-quality evidence) or closure technique (continuous versus interrupted, RR 1.13, 95% CI 0.96 to 1.34, moderate-quality evidence).Similarily, none of the interventions reduced the risk of wound dehiscence whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.78, 95% CI 0.55 to 1.10, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.55, 95% CI 0.92 to 2.61, moderate-quality evidence), closure method (mass versus layered, RR 0.69, 95% CI 0.31 to 1.52, moderate-quality evidence) or closure technique (continuous versus interrupted, RR 1.21, 95% CI 0.90 to 1.64, moderate-quality evidence).Absorbable sutures, compared with non-absorbable sutures (RR 0.49, 95% CI 0.26 to 0.94, low-quality evidence) reduced the risk of sinus or fistula tract formation. None of the other comparisons showed a difference (slow versus fast absorbable sutures, RR 0.88, 95% CI 0.05 to 16.05, very low-quality evidence; mass versus layered, RR 0.49, 95% CI 0.15 to 1.62, low-quality evidence; continuous versus interrupted, RR 1.51, 95% CI 0.64 to 3.61, very low-quality evidence).
Based on this moderate-quality body of evidence, monofilament sutures may reduce the risk of incisional hernia. Absorbable sutures may also reduce the risk of sinus or fistula tract formation, but this finding is based on low-quality evidence.We had serious concerns about the design or reporting of several of the 55 included trials. The comparator arms in many trials differed by more than one component, making it impossible to attribute differences between groups to any one component. In addition, the patient population included in many of the studies was very heterogeneous. Trials included both emergency and elective cases, different types of disease pathology (e.g. colon surgery, hepatobiliary surgery, etc.) or different types of incisions (e.g. midline, paramedian, subcostal).Consequently, larger, high-quality trials to further address this clinical challenge are warranted. Future studies should ensure that proper randomisation and allocation techniques are performed, wound assessors are blinded, and that the duration of follow-up is adequate. It is important that only one type of intervention is compared between groups. In addition, a homogeneous patient population would allow for a more accurate assessment of the interventions.
Background Hybrid coronary revascularization (HCR) represents a minimally invasive revascularization strategy in which the durability of the internal mammary artery to left anterior descending artery ...graft is combined with percutaneous coronary intervention to treat remaining lesions. We performed a systematic review and meta-analysis to compare clinical outcomes after HCR with conventional coronary artery bypass graft (CABG) surgery. Methods A comprehensive EMBASE and PUBMED search was performed for comparative studies evaluating in-hospital and 1-year death, myocardial infarction (MI), stroke, and repeat revascularization. Results Six observational studies (1 case control, 5 propensity adjusted) comprising 1,190 patients were included; 366 (30.8%) patients underwent HCR (185 staged and 181 concurrent), and 824 (69.2%) were treated with CABG (786 off-pump, 38 on-pump). Drug-eluting stents were used in 328 (89.6%) patients undergoing HCR. Hybrid coronary revascularization was associated with lower in-hospital need for blood transfusions, shorter length of stay, and faster return to work. No significant differences were found for the composite of death, MI, stroke, or repeat revascularization during hospitalization (odds ratio 0.63, 95% CI 0.25-1.58, P = .33) and at 1-year follow-up (odds ratio 0.49, 95% CI 0.20-1.24, P = .13). Comparisons of individual components showed no difference in all-cause mortality, MI, or stroke, but higher repeat revascularization among patients treated with HCR. Conclusions Hybrid coronary revascularization is associated with lower morbidity and similar in-hospital and 1-year major adverse cerebrovascular or cardiac events rates, but greater requirement for repeat revascularization compared with CABG. Further exploration of this strategy with adequately powered randomized trials is warranted.
Objective
This meta-analysis aims to determine if antibiotic-impregnated sutures for abdominal fascial closure prevent postoperative surgical site infections (SSIs), hernias, and/or dehiscence.
...Methods
MEDLINE and EMBASE databases (1946–2016) were searched. Randomized controlled trials comparing antibiotic-impregnated sutures to standard sutures for abdominal closure were eligible. Risk of bias was evaluated using the Cochrane Handbooks definitions.
Results
Four-hundred fifty articles were reviewed; five eligible studies (
N
= 3117) were identified. All studies routinely used prophylactic antibiotics. Overall risk of SSI in the antibiotic-impregnated suture group was 10.4 vs. 13.0% in the control group. Pooled data showed no difference in SSI between suture types (odds ratio 0.79, 95% CI 0.57–1.09,
P
= 0.15,
I
2
= 44%). There was no evidence of subgroup effect by suture material (polydioxanone vs. polyglactin 910;
P
= 0.19) or by comparing colorectal surgery studies to others (
P
= 0.67). There was a high risk of bias in two studies, one for high loss to follow-up and one for not using an intent-to-treat analysis.
Conclusion
Our meta-analysis is the most comprehensive review on the utility of antibiotic-impregnated sutures in abdominal surgery to prevent SSI. We found no evidence to support routine use of these sutures.
Aims
Large venous invasion (VI) is prognostically significant in colon cancer. The increased use of elastic stains by pathologists results in higher VI detection rates compared to routine stains ...alone. This study assesses the prognostic value of VI detected by elastic versus routine stains.
Methods and results
Colon cancers resected between 2014 and 2017 underwent pathology slide review for VI. Cases without VI on routine stain were stained by elastic trichrome and re‐examined. Demographic, clinical, pathological and outcome data were gathered by retrospective review. Kaplan–Meier curves with log‐rank tests were performed for survival categorised by VI status. Cox regression was performed for multivariate analysis. Of 277 cases, 97 (35%) showed VI by routine stain alone, with an additional 58 (21%) discovered by subsequent elastic stains. Thus, elastic trichrome increased VI detection by 60%. However, only VI detected by routine stain showed worse overall survival (P < 0.001). VI detected by elastic stain only was not prognostically different from cases without VI (P = 0.428). For stage 2 cancers, VI was not prognostically significant regardless of method of detection. For stage 3 cases, only VI detected by routine stain was prognostic for overall survival (P = 0.002) with a hazard ratio of 4.04 by multivariate regression (P = 0.028).
Conclusions
VI detectable only by elastic stains do not show prognostic significance for survival in colon cancer. For pathologists with high baseline VI detections rates on routine stain, reflexive use of elastic stain may be of limited value.
Venous invasion (VI) in colon cancer detectable only on ancillary elastic stains has minimal prognostic value if there is high baseline VI detection on routine stains.
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