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1.
Colorectal Dis ; 2024 May 08.
Article En | MEDLINE | ID: mdl-38720514

AIM: While postoperative C-reactive protein (CRP) is used routinely as an early indicator of anastomotic leak (AL), preoperative CRP remains to be established as a potential predictor of AL for elective colorectal surgery. The aim of this systematic review and meta-analysis is to examine the association between preoperative CRP and postoperative complications including AL. METHOD: MEDLINE, EMBASE, Web of Science, PubMed, Cochrane Library and CINAHL databases were searched. Studies with reported preoperative CRP values and short-term surgical outcomes after elective colorectal surgery were included. An inverse variance random effects meta-analysis was performed for all meta-analysed outcomes to determine if patients with or without complications and AL differed in their preoperative CRP levels. Risk of bias was assessed with MINORS and certainty of evidence with GRADE. RESULTS: From 1945 citations, 23 studies evaluating 7147 patients were included. Patients experiencing postoperative infective complications had significantly greater preoperative CRP values [eight studies, n = 2421 patients, mean difference (MD) 8.0, 95% CI 3.77-12.23, p < 0.01]. A significant interaction was observed with subgroup analysis based on whether patients were undergoing surgery for inflammatory bowel disease (X2 = 8.99, p < 0.01). Preoperative CRP values were not significantly different between patients experiencing and not experiencing AL (seven studies, n = 3317, MD 2.15, 95% CI -2.35 to 6.66, p = 0.35), nor were they different between patients experiencing and not experiencing overall postoperative morbidity (nine studies, n = 2958, MD 4.54, 95% CI -2.55 to 11.62, p = 0.31) after elective colorectal surgery. CONCLUSION: Higher preoperative CRP levels are associated with increased rates of overall infective complications, but not with AL alone or with overall morbidity in patients undergoing elective colorectal surgery.

2.
J Surg Oncol ; 2024 Apr 25.
Article En | MEDLINE | ID: mdl-38664921

BACKGROUND: Preoperative antibiotic options for pancreaticoduodenectomy (PD) include cefoxitin (CX), piperacillin-tazobactam (PT), or combined cefazolin and metronidazole (CM). Recent studies suggest the superiority of PT over CX, but evidence for CM is unclear. OBJECTIVE: To explore the impact of preoperative antibiotic selection (CM vs. PT and CX vs. PT) on the development of surgical site infections (SSI). METHODS: Consecutive adult patients at one institution who underwent PD from November 2017 to December 2021 and received either CM, PT, or CX preoperatively, were included. The primary outcome was SSI. Secondary outcomes included postoperative infections and clinically significant postoperative pancreatic fistula (POPF). Logistic regression models were used. RESULTS: Among 127 patients included in the study, PT, CM, and CX were administered in 46 (36.2%), 44 (34.6%), and 37 (29.4%) patients, respectively. There were 32 (27.1%) SSI, 20 (36.1%) infections, and 21 (22.9%) POPF events. PT use was associated with reduced risk of SSI compared to CX (OR: 0.32, 95% CI: 0.11-0.89, p = 0.03), but there was no difference as compared to CM (OR: 0.75, 95% CI: 0.27-2.13, p = 0.59). There were no differences in secondary outcomes. CONCLUSION: PT reduced SSI rates compared to CX but was no different to CM among patients undergoing PD at our center.

3.
Article En | MEDLINE | ID: mdl-38678106

PURPOSE: To compare pronator quadratus preserving (PQ-P) approaches with PQ dissecting (PQ-D) approaches in volar plate fixation of distal radius fractures (DRFs). METHODS: Three databases were searched on March 10th, 2024. The authors adhered to the PRISMA and R-AMSTAR guidelines and Cochrane Handbook for Systematic Reviews. Data on demographics, fracture classifications, patient reported outcome measures (PROMs), range of motion, radiographic parameters, and complications were extracted. RESULTS: Thirteen studies with a total of 1007 fractures were included. Two of three studies reported lower DASH scores in the PQ-P group between 6 weeks and 3 months postoperative, however no studies reported lower scores in the PQ-P group after 3 months. Three of three studies reported significantly lower VAS scores at 6 weeks postoperative, however no studies reported significant differences after 6 months. Only one of six studies reported significantly greater flexion, extension, and pronation in the PQ-P group. One of four studies reported greater radial deviation in the PQ-P group, while there were no differences in supination or ulnar deviation. One of ten and one of six studies reported greater volar tilt and ulnar variance or radial length, respectively, in the PQ-P group. CONCLUSION: There is not sufficient evidence supporting the utility of PQ-P approaches over conventional PQ-D approaches for volar plate fixation of DRFs, especially at long-term follow-ups (3+ months). There may be short term benefits with PQ-P approaches, specifically with regards to PROMs in the short-term (< 6 weeks), however there is limited high-quality evidence supporting these findings. LEVEL OF EVIDENCE: Level III.

4.
Surg Obes Relat Dis ; 2024 Mar 24.
Article En | MEDLINE | ID: mdl-38644078

BACKGROUND: The formulation of clinical recommendations pertaining to bariatric surgery is essential in guiding healthcare professionals. However, the extensive and continuously evolving body of literature in bariatric surgery presents considerable challenge for staying abreast of latest developments and efficient information acquisition. Artificial intelligence (AI) has the potential to streamline access to the salient points of clinical recommendations in bariatric surgery. OBJECTIVES: The study aims to appraise the quality and readability of AI-chat-generated answers to frequently asked clinical inquiries in the field of bariatric and metabolic surgery. SETTING: Remote. METHODS: Question prompts inputted into AI large language models (LLMs) and were created based on pre-existing clinical practice guidelines regarding bariatric and metabolic surgery. The prompts were queried into 3 LLMs: OpenAI ChatGPT-4, Microsoft Bing, and Google Bard. The responses from each LLM were entered into a spreadsheet for randomized and blinded duplicate review. Accredited bariatric surgeons in North America independently assessed appropriateness of each recommendation using a 5-point Likert scale. Scores of 4 and 5 were deemed appropriate, while scores of 1-3 indicated lack of appropriateness. A Flesch Reading Ease (FRE) score was calculated to assess the readability of responses generated by each LLMs. RESULTS: There was a significant difference between the 3 LLMs in their 5-point Likert scores, with mean values of 4.46 (SD .82), 3.89 (.80), and 3.11 (.72) for ChatGPT-4, Bard, and Bing (P < .001). There was a significant difference between the 3 LLMs in the proportion of appropriate answers, with ChatGPT-4 at 85.7%, Bard at 74.3%, and Bing at 25.7% (P < .001). The mean FRE scores for ChatGPT-4, Bard, and Bing, were 21.68 (SD 2.78), 42.89 (4.03), and 14.64 (5.09), respectively, with higher scores representing easier readability. CONCLUSIONS: LLM-based AI chat models can effectively generate appropriate responses to clinical questions related to bariatric surgery, though the performance of different models can vary greatly. Therefore, caution should be taken when interpreting clinical information provided by LLMs, and clinician oversight is necessary to ensure accuracy. Future investigation is warranted to explore how LLMs might enhance healthcare provision and clinical decision-making in bariatric surgery.

5.
BMJ Open ; 14(4): e085293, 2024 Apr 23.
Article En | MEDLINE | ID: mdl-38658008

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.


Checklist , Randomized Controlled Trials as Topic , Research Design , Randomized Controlled Trials as Topic/standards , Humans , Pilot Projects , Research Design/standards , Surgical Procedures, Operative/standards , Feasibility Studies , Research Report/standards
6.
Colorectal Dis ; 2024 Apr 04.
Article En | MEDLINE | ID: mdl-38576076

AIM: Preoperative frailty has been associated with adverse postoperative outcomes in various populations, but of its use in patients with inflammatory bowel disease (IBD) remains sparse. The present study aimed to characterize the impact of frailty, as measured by the modified frailty index (mFI), on postoperative clinical and resource utilization outcomes in patients with IBD. METHODS: This retrospective population-based cohort study assessed patients from the National Inpatient Sample database from 1 September 2015 to 31 December 2019. Corresponding International Classification of Diseases 10th Revision Clinical Modification codes were used to identify adult patients (>18 years of age) with IBD, undergoing either small bowel resection, colectomy or proctectomy. Patient demographics and institutional data were collected for each patient to calculate the 11-point mFI. Patients were categorized as either frail or robust using a cut-off of 0.27. Primary outcomes were postoperative in-hospital morbidity and mortality, whilst secondary outcomes included system-specific morbidity, length of stay, in-hospital healthcare costs and discharge disposition. Logistic and linear regression models were used for primary and secondary outcomes. RESULTS: Overall, 7144 patients with IBD undergoing small bowel resection, colectomy or proctectomy were identified, 337 of whom were classified as frail (i.e., mFI < 0.27). Frail patients were more likely to be women, older, have lower income and a greater number of comorbidities. After adjusting for relevant covariates, frail patients were at greater odds of in-hospital mortality (adjusted odds ratio [aOR] 5.42, 95% CI 2.31-12.77, P < 0.001), overall morbidity (aOR 1.72, 95% CI 1.30-2.28, P < 0.001), increased length of stay (adjusted mean difference 1.3 days, 95% CI 0.09-2.50, P = 0.035) and less likely to be discharged to home (aOR 0.59, 95% CI 0.45-0.77, P < 0.001) compared to their robust counterparts. CONCLUSIONS: Frail IBD patients are at greater risk of postoperative mortality and morbidity, and reduced likelihood of discharge to home, following surgery. This has implications for clinicians designing care pathways for IBD patients following surgery.

7.
PLoS One ; 19(4): e0302482, 2024.
Article En | MEDLINE | ID: mdl-38687754

BACKGROUND: Preoperative very low energy diet (VLED) interventions are used routinely in patients undergoing bariatric surgery, a surgical subspecialty that deals almost exclusively with patients with obesity. Yet, their use and study has been limited in non-bariatric abdominal surgery. To investigate the use of VLEDs in non-bariatric surgery, we plan on conducting a randomized controlled trial (RCT). Prior to proceeding, however, we have designed two surveys as important pre-emptive studies aimed at elucidating patient and provider perspectives regarding these interventions. METHODS: The patient survey is a cross-sectional, single-center survey aimed at assessing the safety, adherence, barriers to adherence, and willingness to participate in preoperative optimization protocols with VLEDs prior to undergoing elective non-bariatric intra-abdominal surgery (S1 File). The population of interest is all adult patients with obesity undergoing elective non-bariatric intra-abdominal surgery at St. Joseph's Healthcare Hamilton who were prescribed a course of preoperative VLED. The primary outcomes will be safety and adherence. The target sample size is 35 survey responses. The provider survey is a cross-sectional national survey of practicing surgeons in Canada who perform major non-bariatric abdominal surgery aimed assessing the willingness and ability to prescribe preoperative weight loss interventions amongst practicing Canadian surgeons who perform major non-bariatric abdominal surgery (S2 File). The population of interest is independent practicing surgeons in Canada who perform major non-bariatric abdominal surgery. The primary outcome will be willingness to prescribe preoperative VLED to patients with obesity undergoing major non-bariatric abdominal surgery for both benign and malignant indications. The target sample size is 61 survey responses. Descriptive statistics will be used to characterize the sample populations. To determine variables associated with primary outcomes in the surveys, regression analyses will be performed. DISCUSSION: These survey data will ultimately inform the design of an RCT evaluating the efficacy of preoperative VLEDs for patients with obesity undergoing major abdominal surgery.


Preoperative Care , Weight Loss , Humans , Cross-Sectional Studies , Surveys and Questionnaires , Abdomen/surgery , Obesity/surgery , Female , Adult , Male , Bariatric Surgery/methods
8.
BMJ Open ; 14(3): e081367, 2024 Mar 21.
Article En | MEDLINE | ID: mdl-38514152

OBJECTIVE: To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery. DESIGN: We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants. PARTICIPANTS & SETTING: Surgeons and surgeon trainees in the Department of Surgery at McMaster University. OUTCOMES: The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses. RESULTS: 82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24-73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p<0.001). While participants scored significantly higher than the average adult on fluency (the ability to produce quantities of ideas) and flexibility (the ability to process information in different ways) (p<0.001 for both), they scored below average on originality (the ability to produce uncommon, new or unique ideas) (p<0.001). Regression analysis identified higher divergent thinking scores among females (estimated ß=-3.58 (95% CI -6.25 to -0.90), p=0.010). CONCLUSIONS: The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.


Surgeons , Thinking , Adult , Humans , Female , Young Adult , Middle Aged , Aged , Male , Thinking/physiology , Creativity , Problem Solving , Canada
9.
Am Surg ; : 31348241241683, 2024 Mar 26.
Article En | MEDLINE | ID: mdl-38530772

BACKGROUND: Prolonged postoperative ileus (PPOI) contributes to morbidity and prolonged hospitalization. Prucalopride, a selective 5-hydroxytryptamine receptor agonist, may enhance bowel motility. This review assesses whether the perioperative use of prucalopride compared to placebo is associated with accelerated return of bowel function post gastrointestinal (GI) surgery. METHODS: OVID, CENTRAL, and EMBASE were searched as of January 2024 to identify randomized controlled trials (RCTs) comparing prucalopride and placebo for prevention of PPOI in adult patients undergoing GI surgery. The primary outcomes were time to stool, time to flatus, and time to oral tolerance. The secondary outcomes were incidence of PPOI, length of stay (LOS), postoperative complications, adverse events, and overall costs. The Cochrane risk of bias tool for randomized trials and the Grading of Recommendations, Assessment, Development, and Evaluations framework were used. An inverse variance random effects model was used. RESULTS: From 174 citations, 3 RCTs with 139 patients in each treatment group were included. Patients underwent a variety of GI surgeries. Patients treated with prucalopride had a decreased time to stool (mean difference 36.82 hours, 95% CI 59.4 to 14.24 hours lower, I2 = 62%, low certainty evidence). Other outcomes were not statistically significantly different (very low certainty evidence). Postoperative complications and adverse events could not be meta-analyzed due to heterogeneity; yet individual studies suggested no significant differences (very low certainty evidence). DISCUSSION: Current RCT evidence suggests that prucalopride may enhance postoperative return of bowel function. Larger RCTs assessing patient important outcomes and associated costs are needed before routine use of this agent.

10.
J Surg Res ; 297: 71-82, 2024 May.
Article En | MEDLINE | ID: mdl-38447338

INTRODUCTION: Studies identifying predictors of postoperative outcomes in adhesive small bowel obstruction are limited. This study investigates the efficacy of the modified frailty index (mFI)to predict postoperative morbidity and mortality among patients undergoing surgery for adhesive small bowel obstruction. METHODS: A multicentre retrospective cohort study including patients undergoing surgery for adhesive small bowel obstruction after failed trial of nonoperative management between January 2015 and December 2020 was performed. Impact of frailty status using the mFI, stratified as frail (≥0.27) and robust (<0.27), on postoperative morbidity, mortality, length of stay, and discharge destination was evaluated using multiple logistic regression. RESULTS: Ninety-two robust patients (mean age 62.4 y, 68% female) and 41 frail patients (mean age 81.7 y, 63% female) were included. On simple stratification, frail patients had significantly increased 30-d morbidity (overall morbidity 80% versus 49%) and need for higher level of care on discharge (41% versus 9%). However, on multiple regression, functional dependence but not the mFI, was independently associated with worse 30-d overall morbidity (odds ratio [OR] 3.97, confidence interval [CI] 1.29-12.19) and lower likelihood of returning to preoperative disposition (OR 0.21, CI 0.05-0.91). The delay in operation beyond 5 d was independently associated with worse 30-d outcomes including overall morbidity and mortality (OR 7.54, CI 2.13-26.73) and decreased return to preoperative disposition (OR 0.14, CI 0.04-0.56). CONCLUSIONS: The mFI, although promising, was not independently predictive of outcomes following surgery for adhesive small bowel obstruction. Further adequately powered studies are required.


Frailty , Intestinal Obstruction , Humans , Female , Middle Aged , Aged, 80 and over , Male , Retrospective Studies , Intestinal Obstruction/surgery , Morbidity , Postoperative Complications , Risk Factors , Risk Assessment
11.
J Clin Epidemiol ; 170: 111335, 2024 Mar 27.
Article En | MEDLINE | ID: mdl-38548230

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

12.
J Gastrointest Surg ; 28(3): 205-214, 2024 Mar.
Article En | MEDLINE | ID: mdl-38445910

BACKGROUND: There are limited data identifying predictors of postoperative outcomes in adhesive small bowel obstruction (ASBO). This study used the National Inpatient Sample (NIS) to assess the efficacy of the modified frailty index (mFI) to predict postoperative morbidity among patients undergoing an operation for ASBO. METHODS: A retrospective analysis of the NIS between September 1, 2015, and December 31, 2019, was performed to identify adult patients who underwent nonelective operative intervention for ASBO. The mFI was used to stratify patients as either frail (mFI value ≥ 0.27) or robust (mFI value < 0.27). The primary outcomes were overall in-hospital postoperative morbidity and mortality. The secondary outcomes were system-specific morbidity, length of stay (LOS), total in-hospital healthcare cost, and discharge disposition. Univariable and multivariable regressions were used. RESULTS: Overall, 23251 robust patients and 6122 frail patients were included. Adjusted analyses demonstrated that frail patients had increased in-hospital mortality (adjusted odds ratio [aOR], 2.16; 95% CI, 1.80-2.60), postoperative morbidity (aOR, 1.63; 95% CI, 1.52-1.74), postoperative LOS (adjusted mean difference [aMD], 0.97 days; 95% CI, 0.73-1.21), and total in-hospital healthcare costs (aMD, $18,921; 95% CI, $14,608-$23,235) and were less likely to be discharged home (aOR, 0.59; 95% CI, 0.55-0.63). The findings were unchanged on subgroup analysis of patients undergoing open operation and those older than 65 years of age. CONCLUSION: The mFI may predict postoperative outcomes for ASBO. Stratifying patients based on frailty may assist clinicians and patients in making informed decisions, setting realistic expectations, and proactively planning postoperative disposition.


Frailty , Intestinal Obstruction , Adult , Humans , Inpatients , Frailty/complications , Retrospective Studies , Decision Making , Intestinal Obstruction/surgery , Morbidity
13.
Colorectal Dis ; 26(4): 692-701, 2024 Apr.
Article En | MEDLINE | ID: mdl-38353528

AIM: Financial toxicity describes the financial burden and distress that patients experience due to medical treatment. Financial toxicity has yet to be characterized among patients with inflammatory bowel disease (IBD) undergoing surgical management of their disease. This study investigated the risk of financial toxicity associated with undergoing surgery for IBD. METHODS: This study used a retrospective analysis using the National Inpatient Sample from 2015 to 2019. Adult patients who underwent IBD-related surgery were identified using the International Classification of Diseases (10th Revision) diagnostic and procedure codes and stratified into privately insured and uninsured groups. The primary outcome was risk of financial toxicity, defined as hospital admission charges that constituted 40% or more of patient's post-subsistence income. Secondary outcomes included total hospital admission cost and predictors of financial toxicity. RESULTS: The analytical cohort consisted of 6412 privately insured and 3694 uninsured patients. Overall median hospital charges were $21 628 (interquartile range $14 758-$35 386). Risk of financial toxicity was 86.5% among uninsured patients and 0% among insured patients. Predictors of financial toxicity included emergency admission, being in the lowest residential income quartile and having ulcerative colitis (compared to Crohn's disease). Additional predictors were being of Black race or male sex. CONCLUSION: Financial toxicity is a serious consequence of IBD-related surgery among uninsured patients. Given the pervasive nature of this consequence, future steps to support uninsured patients receiving surgery, in particular emergency surgery, related to their IBD are needed to protect this group from financial risk.


Hospital Charges , Inflammatory Bowel Diseases , Medically Uninsured , Humans , Male , Female , Retrospective Studies , United States , Middle Aged , Adult , Medically Uninsured/statistics & numerical data , Hospital Charges/statistics & numerical data , Inflammatory Bowel Diseases/surgery , Inflammatory Bowel Diseases/economics , Colitis, Ulcerative/surgery , Colitis, Ulcerative/economics , Cost of Illness , Crohn Disease/surgery , Crohn Disease/economics , Hospitalization/economics , Hospitalization/statistics & numerical data , Insurance, Health/statistics & numerical data , Insurance, Health/economics , Financial Stress/economics , Aged , Hospital Costs/statistics & numerical data
14.
Radiother Oncol ; 194: 110148, 2024 May.
Article En | MEDLINE | ID: mdl-38341094

BACKGROUND: 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). MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.


Neoadjuvant Therapy , Rectal Neoplasms , Humans , Randomized Controlled Trials as Topic , Rectal Neoplasms/therapy , Rectal Neoplasms/pathology
15.
Clin Breast Cancer ; 24(3): e103-e115, 2024 04.
Article En | MEDLINE | ID: mdl-38296737

Pre-clinical studies in triple negative breast cancer (TNBC) suggest that statins may inhibit cell proliferation, promote cell-cycle arrest, induce apoptosis, change the tumor microenvironment, and improve effectiveness of other therapies. Observational studies have demonstrated variable effects from statin therapy on oncologic outcomes in these patients. As such, we aimed to pool previous data via a systematic review and meta-analysis to elucidate the impact of concurrent statin use on oncologic outcomes for patients with TNBC. Medline, EMBASE, CENTRAL, and PubMed were systematically searched from inception through to June 2022. Studies were included if they compared patients with TNBC receiving and not receiving statin therapy concurrently with oncologic treatment for curative intent in terms of recurrence and survival in a non-metastatic setting. The primary outcomes were 5-year disease-free survival (DFS) and 5-year overall survival (OS). A pairwise meta-analyses was performed using inverse variance random effects. Risk of bias was assessed with the ROBINS-I and the GRADE approach was conducted to assess quality of evidence. From 4014 citations, 5 studies with 625 patients on statin therapy and 2707 patients not on statin therapy were included. There was a significant increase in 5-year DFS for patients on statin therapy compared to patients not on statin therapy (OR 1.44, 95% CI 1.04-1.98, P = .03). No significant difference was noted in 5-year OS between the 2 groups (OR 1.12, 95% CI 0.86-1.47, P = .40). Included studies were at moderate-to-high risk of bias. The GRADE quality of evidence was very low. This review presents very low-quality evidence that concurrent use of statins with oncologic treatment may potentially improve long-term DFS for patients with TNBC undergoing curative intent therapy. Future research by way of large, prospective study is required to further clarify the clinical utility of statins on patients undergoing treatment for TNBC.


Hydroxymethylglutaryl-CoA Reductase Inhibitors , Triple Negative Breast Neoplasms , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology , Triple Negative Breast Neoplasms/drug therapy , Disease-Free Survival , Tumor Microenvironment
16.
Am Surg ; : 31348241227200, 2024 Jan 10.
Article En | MEDLINE | ID: mdl-38199669

BACKGROUND: Postoperative gastrointestinal dysfunction (POGD) commonly occurs following gastrointestinal (GI) surgery and is associated with specific anesthetic agents. Cholinesterase inhibitors employed for reversing neuromuscular blockade have been implicated in development of POGD. Sugammadex, a novel reversal agent, is linked with reduced POGD. However, there is a lack of comprehensive comparative review between these agents regarding their impact on POGD following GI surgery. This study aims to systematically review the effects of sugammadex on POGD compared to cholinesterase inhibitors following GI surgery. METHODS: MEDLINE, EMBASE, and CENTRAL were searched as of July 2022 to identify articles comparing sugammadex with cholinesterase inhibitors in patients undergoing gastrointestinal surgery, specifically in relation to POGD. Secondary endpoints included length of hospital stay, readmission rates, pulmonary complications, and postoperative morbidity. RESULTS: From 198 citations, 2 randomized controlled trials (RCTs) and 3 retrospective cohorts with 717 patients receiving sugammadex and 812 patients receiving cholinesterase inhibitors were included. Significantly lower rates of prolonged postoperative ileus (OR .44, 95% CI .25-.77, P < .05, I2 = 56%, low certainty evidence) was observed with sugammadex. No significant difference in any other outcome was observed. Narrative review of readmission data demonstrated no significant difference. CONCLUSION: The use of sugammadex following gastrointestinal surgery is associated with significantly lower rates of prolonged postoperative ileus compared to cholinesterase inhibitors. However, these do not translate into a significant reduction in length of stay, morbidity, or postoperative nausea and vomiting. Results are limited by the numer of studies included and missing data, more robust RCTs are needed before recommendations can be made.

17.
Int J Colorectal Dis ; 39(1): 17, 2024 Jan 09.
Article En | MEDLINE | ID: mdl-38194054

PURPOSE: Up to 40% of patients with inflammatory bowel disease (IBD) are obese. Obesity is a well-known risk factor for increased perioperative morbidity, but this risk has never been quantified in IBD patients undergoing abdominal surgery using the United States National Inpatient Sample (NIS) database. This study aims to compare postoperative morbidity between obese and non-obese patients undergoing bowel resection for IBD using recent NIS data. METHODS: Adult patients who underwent bowel resection for IBD from 2015 to 2019 were identified in the NIS using ICD-10-CM coding. Patients were stratified into obese (BMI > 30 kg/m2) and non-obese groups, then propensity score matched (PSM) for demographic, operative, and hospital characteristics. The primary outcome was postoperative in-hospital morbidity. Secondary outcomes included postoperative in-hospital mortality, system-specific postoperative complications, total admission healthcare costs, and length of stay (LOS). Univariable and multivariable regressions were utilized. RESULTS: Overall, 6601 non-obese patients and 671 obese patients were identified. The PSM cohort included 659 patients per group. Obese patients had significantly increased odds of experiencing postoperative in-hospital morbidity (aOR 1.50, 95% CI 1.10-2.03, p = 0.010) compared to non-obese patients. Specifically, obese patients experienced increased gastrointestinal complications (aOR 1.49, 95% CI 1.00-2.24, p = 0.050), and genitourinary complications (aOR 1.71, 95% CI 1.12-2.61, p = 0.013). There were no differences in total admission healthcare costs (MD - $2256.32, 95% CI - 19,144.54-14,631.9, p = 0.79) or LOS (MD 0.16 days, 95% CI - 0.93-1.27, p = 0.77). CONCLUSIONS: Obese IBD patients are at greater risk of postoperative in-hospital morbidity than non-obese IBD patients. This supports targeted preoperative weight loss protocols for IBD patients to optimize surgical outcomes.


Digestive System Surgical Procedures , Inflammatory Bowel Diseases , Obesity , Adult , Humans , Digestive System Surgical Procedures/adverse effects , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/surgery , Inpatients , Obesity/complications , Propensity Score , Postoperative Period , Length of Stay , Postoperative Complications
18.
Am Surg ; 90(4): 840-850, 2024 Apr.
Article En | MEDLINE | ID: mdl-37967460

BACKGROUND: Lymph node ratio is the number of lymph nodes with evidence of metastases on pathological review compared to the total number of lymph nodes harvested during oncologic resection. Lymph node ratio is a proven predictor of long-term survival. These data have not been meta-analyzed to determine the prognosis associated with different lymph node ratio cut-offs in colon cancer. METHODS: Medline, Embase, and CENTRAL were systematically searched. Articles were included if they compared 5-year overall survival (OS) or disease-free survival (DFS) between different lymph node ratios for patients undergoing oncologic resection for stages I-III colon cancer. Pairwise meta-analyses using inverse variance random effects were performed. RESULTS: From 2587 citations, nine studies with 97,631 patients (female: 51.9%, median age: 61.65 years) were included. A lymph node ratio above .1 resulted in a 49% decrease in the odds of 5-year OS (2 studies; OR: 0.51, 95% CI: 0.49-.53, P < .00001). A lymph node ratio above .25 resulted in a 56% decrease in the odds of 5-year OS (3 studies; OR: 0.44, 95% CI: 0.43-.45, P < .00001). A lymph node ratio above .5 resulted in a 65% decrease in the odds of 5-year OS (3 studies; OR: 0.35, 95% CI: 0.33-.37, P < .00001). CONCLUSIONS: Lymph node ratios from .1 to .5 are effective predictors of 5-year OS for colon cancer. There appears to be an inverse dose-response relationship between lymph node ratio and 5-year OS. Further study is required to determine whether there is an optimal lymph node ratio cut-off for prognostication and whether it can inform which patients may benefit from more aggressive adjuvant therapy and follow-up protocols.


Colonic Neoplasms , Lymph Node Ratio , Humans , Colonic Neoplasms/surgery , Combined Modality Therapy , Disease-Free Survival , Lymph Nodes
19.
Dis Colon Rectum ; 67(3): 414-426, 2024 Mar 01.
Article En | MEDLINE | ID: mdl-37889999

BACKGROUND: The p value has been criticized as an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation of the minimum number of nonevents that would need to be converted to events to increase the p value above 0.05. OBJECTIVE: To determine the fragility index of randomized controlled trials assessing the efficacy of interventions for patients with diverticular disease since 2010 to assess the robustness of current evidence. DESIGN: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to August 2022. SETTINGS: Articles were eligible for inclusion if they were randomized trials conducted between 2010 and 2022 with parallel, superiority designs evaluating interventions in patients with diverticular disease. Only randomized trials with dichotomous primary outcomes with an associated p value of <0.05 were considered for inclusion. PARTICIPANTS: Any surgical or medical intervention for patients with diverticular disease. MAIN OUTCOME MEASURES: The fragility index was determined by adding events and subtracting nonevents from the groups with the smaller number of events. Events were added until the p value exceeded 0.05. The smallest number of events required was considered the fragility index. RESULTS: After screening 1271 citations, 15 randomized trials met the inclusion criteria. Nine of the studies evaluated surgical interventions and 6 evaluated medical interventions. The mean number of patients randomly assigned and lost to follow-up per randomized controlled trial was 92 (SD 35.3) and 9 (SD 11.4), respectively. The median fragility index was 1 (range, 0-5). The fragility indices for the included studies did not correlate significantly with any study characteristics. LIMITATIONS: Small sample, heterogeneity, and lack of inclusion of studies with continuous outcomes. CONCLUSIONS: The randomized trials evaluating surgical and medical interventions for diverticular disease are not robust. Changing a single-outcome event in most studies was sufficient to make a statistically significant study finding not significant. See Video Abstract . FRAGILIDAD DE LOS RESULTADOS ESTADSTICAMENTE SIGNIFICATIVOS EN ENSAYOS ALEATORIOS DE ENFERMEDAD DIVERTICULAR DEL COLON UNA REVISIN SISTEMTICA: ANTECEDENTES:El valor p ha sido criticado por una determinación demasiado simplificada de si existe un efecto del tratamiento. Una alternativa es el Índice de Fragilidad. Es una representación del número mínimo de no eventos que deberían convertirse en eventos para aumentar el valor p por encima de 0,05.OBJETIVO:Determinar el IF de ensayos controlados aleatorios que evalúan la eficacia de las intervenciones para pacientes con enfermedad diverticular desde 2010 para evaluar la solidez de la evidencia actual.FUENTES DE DATOS:Se realizaron búsquedas en MEDLINE, Embase y CENTRAL desde el inicio hasta agosto de 2022.SELECCIÓN DE ESTUDIOS:Los artículos eran elegibles para su inclusión si eran ensayos aleatorizados realizados entre 2010 y 2022 con diseños paralelos de superioridad que evaluaran intervenciones en pacientes con enfermedad diverticular. Sólo se consideraron para su inclusión los ensayos aleatorizados con resultados primarios dicotómicos con un valor de p asociado menor que 0,05.INTERVENCIÓNES:Cualquier intervención quirúrgica o médica para pacientes con enfermedad diverticular.PRINCIPALES MEDIDAS DE VALORACIÓN:El índice de fragilidad se determinó sumando eventos y restando no eventos de los grupos con el menor número de eventos. Se agregaron eventos hasta que el valor p superó 0,05. El menor número de eventos requeridos se consideró índice de fragilidad.RESULTADOS:Después de examinar 1271 citas, 15 ensayos aleatorios cumplieron los criterios de inclusión. Nueve de los estudios evaluaron intervenciones quirúrgicas y seis evaluaron intervenciones médicas. El número medio de pacientes aleatorizados y perdidos durante el seguimiento por ECA fue 92 (DE 35,3) y 9 (DE 11,4), respectivamente. La mediana del índice de fragilidad fue 1 (rango: 0-5). Los índices de fragilidad de los estudios incluidos no se correlacionaron significativamente con ninguna característica del estudio.LIMITACIONES:Muestra pequeña, heterogeneidad y falta de inclusión de estudios con resultados continuos.CONCLUSIONES:Los ensayos aleatorios que evalúan las intervenciones quirúrgicas y médicas para la enfermedad diverticular no son sólidos. Cambiar un solo evento de resultado en la mayoría de los estudios fue suficiente para que un hallazgo estadísticamente significativo del estudio no fuera significativo. (Traducción- Dr. Ingrid Melo ).


Diverticular Diseases , Diverticulosis, Colonic , Diverticulum, Colon , Humans , Randomized Controlled Trials as Topic , Diverticulosis, Colonic/therapy , Diverticular Diseases/therapy , Diverticulum, Colon/surgery , Retrospective Studies
20.
Colorectal Dis ; 26(1): 7-21, 2024 Jan.
Article En | MEDLINE | ID: mdl-37985859

BACKGROUND: Maintenance of normothermia is a crucial part of enhanced recovery after colorectal surgery. Dry-cold carbon dioxide (CO2 ) traditionally used for insufflation in laparoscopic surgery and negative pressure operating theatres has been associated with intraoperative hypothermia. Studies suggest that use of warmed-humidified CO2 may promote normothermia. However, due to a scarcity of high-quality studies demonstrating a proven benefit on intraoperative core body temperature, its use in colorectal surgery remains limited. Therefore, the aim of this review was to evaluate the effects of warmed-humidified CO2 compared to traditional dry-cold CO2 , or ambient air in operating theatres, during colorectal surgery. METHODS: A search of Medline, EMBASE, and CENTRAL was performed. Randomised controlled trials (RCTs) that compared patients receiving warmed-humidified CO2 with either dry-cold CO2 insufflation in laparoscopic procedures or no insufflation during open surgery were included. The primary outcome was change in intraoperative core body temperature. Secondary outcomes included length of stay, operating time, return of gastrointestinal function, wound infection, and postoperative pain. A pairwise meta-analysis was performed using inverse variance random effects. RESULTS: Among the six RCTs included, 208 patients received warmed-humidified CO2 (42.3% female, mean age: 65.8 years) and 210 patients received either dry-cold CO2 in laparoscopic procedures or no gas insufflation during open procedures (46.2% female, mean age: 66.1 years). No significant difference was found for change in intraoperative core body temperature (MD = 0.01, 95% CI: -0.1, 0.11, p = 0.90, very low certainty). Patients in the warmed-humidified CO2 group had significantly higher pain scores on postoperative day 1 (MD = 1.61, 95% CI: 0.91, 2.31, p < 0.05, very low certainty). No significant differences were found in any of the other secondary outcomes studied. CONCLUSION: Patients undergoing colorectal surgery receiving warmed-humidified CO2 do not experience any clinically meaningful difference in core body temperature change compared to their counterparts receiving dry-cold CO2 insufflation or no insufflation. However, patients may report greater pain scores on postoperative day 1 with warmed-humidified CO2 . There is likely no clinically important difference between warmed-humidified CO2 and dry-cold CO2 for patients undergoing colorectal surgery. Patient, clinician, and institution factors should be considered when deciding between these two insufflation modalities.


Colorectal Surgery , Insufflation , Laparoscopy , Female , Humans , Aged , Male , Carbon Dioxide , Insufflation/methods , Humidity , Laparoscopy/methods , Pain, Postoperative/etiology
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