Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice.

OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.

The relationship between plate prominence and need for removal after volar plate osteosynthesis of distal radius fractures.

PURPOSE: This study aimed to assess the incidence of plate-related complications and the need for plate removal after volar plate osteosynthesis of the distal radius in relation to Soong classification. METHODS: All consecutive patients (age > 16 years) in our level II trauma center treated with plate osteosynthesis for distal radius fractures from January 2017 until June 2019 were retrospectively evaluated. The main outcome measures were volar plate positioning according to Soong classification and incidence of plate removal. In addition, the incidence of tendon ruptures, reasons for volar plate removal, and improvement of complaints after removal were evaluated. RESULTS: The overall incidence of plate removal in the 336 included patients was 16.9% (n = 57). Removal incidence in Soong 2 plates (28.2%) was significantly higher compared to Soong 0 and 1 plates (8.0% and 14.4%, respectively), P = 0.003. Multivariable binary logistic regression analysis showed Soong grade 2 as an independent predictor for plate removal, OR 4.3 (95% CI 1.4-13.7, P = 0.013). Four cases of flexor and four cases of extensor tendon rupture were reported, all in Soong 2 grade plating. The main reasons for volar plate removal were pain (42%) and reduced functionality (12%). In cases where pain was the main reason for removal, 81% of patients reported a decrease in pain during follow-up after surgery. CONCLUSIONS: This study suggests an association between plate prominence graded by Soong and plate removal using a single plating system. Plate prominence should be reduced in volar plating whenever technically feasible.

Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial).

BACKGROUND: Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail. METHODS: This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1-5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0-10) at POD 1-10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia. RESULTS: Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1-3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p < 0.001). After correcting for epidural analgesia, these differences remained significant at POD 1-2 (47 mg OME, p = 0.002 and 69 mg OME, p < 0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids (p = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs, < 2 at discharge, and did not relevantly differ between treatment arms. CONCLUSION: In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids. TRIAL REGISTRATION: NCT02248519.

Cost-effectiveness of Laparoscopic vs Open Gastrectomy for Gastric Cancer: An Economic Evaluation Alongside a Randomized Clinical Trial.

Importance: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective: To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants: In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions: Laparoscopic vs open gastrectomy. Main Outcomes and Measures: Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results: Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, -0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance: Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers' choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.

Body Composition Is a Predictor for Postoperative Complications After Gastrectomy for Gastric Cancer: a Prospective Side Study of the LOGICA Trial.

PURPOSE: There is a lack of prospective studies evaluating the effects of body composition on postoperative complications after gastrectomy in a Western population with predominantly advanced gastric cancer. METHODS: This is a prospective side study of the LOGICA trial, a multicenter randomized trial on laparoscopic versus open gastrectomy for gastric cancer. Trial patients who received preoperative chemotherapy followed by gastrectomy with an available preoperative restaging abdominal computed tomography (CT) scan were included. The CT scan was used to calculate the mass (M) and radiation attenuation (RA) of skeletal muscle (SM), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT). These variables were expressed as Z-scores, depicting how many standard deviations each patient's CT value differs from the sex-specific study sample mean. Primary outcome was the association of each Z-score with the occurrence of a major postoperative complication (Clavien-Dindo grade ≥ 3b). RESULTS: From 2015 to 2018, a total of 112 patients were included. A major postoperative complication occurred in 9 patients (8%). A high SM-M Z-score was associated with a lower risk of major postoperative complications (RR 0.47, 95% CI 0.28-0.78, p = 0.004). Furthermore, high VAT-RA Z-scores and SAT-RA Z-scores were associated with a higher risk of major postoperative complications (RR 2.82, 95% CI 1.52-5.23, p = 0.001 and RR 1.95, 95% CI 1.14-3.34, p = 0.015, respectively). VAT-M, SAT-M, and SM-RA Z-scores showed no significant associations. CONCLUSION: Preoperative low skeletal muscle mass and high visceral and subcutaneous adipose tissue radiation attenuation (indicating fat depleted of triglycerides) were associated with a higher risk of developing a major postoperative complication in patients treated with preoperative chemotherapy followed by gastrectomy.

Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial.

BACKGROUND: The oncological efficacy and safety of laparoscopic gastrectomy are under debate for the Western population with predominantly advanced gastric cancer undergoing multimodality treatment. METHODS: In 10 experienced upper GI centers in the Netherlands, patients with resectable (cT1-4aN0-3bM0) gastric adenocarcinoma were randomly assigned to either laparoscopic or open gastrectomy. No masking was performed. The primary outcome was hospital stay. Analyses were performed by intention to treat. It was hypothesized that laparoscopic gastrectomy leads to shorter hospital stay, less postoperative complications, and equal oncological outcomes. RESULTS: Between 2015 and 2018, a total of 227 patients were randomly assigned to laparoscopic (n = 115) or open gastrectomy (n = 112). Preoperative chemotherapy was administered to 77 patients (67%) in the laparoscopic group and 87 patients (78%) in the open group. Median hospital stay was 7 days (interquartile range, 5-9) in both groups (P = .34). Median blood loss was less in the laparoscopic group (150 v 300 mL, P < .001), whereas mean operating time was longer (216 v 182 minutes, P < .001). Both groups did not differ regarding postoperative complications (44% v 42%, P = .91), in-hospital mortality (4% v 7%, P = .40), 30-day readmission rate (9.6% v 9.1%, P = 1.00), R0 resection rate (95% v 95%, P = 1.00), median lymph node yield (29 v 29 nodes, P = .49), 1-year overall survival (76% v 78%, P = .74), and global health-related quality of life up to 1 year postoperatively (mean differences between + 1.5 and + 3.6 on a 1-100 scale; 95% CIs include zero). CONCLUSION: Laparoscopic gastrectomy did not lead to a shorter hospital stay in this Western multicenter randomized trial of patients with predominantly advanced gastric cancer. Postoperative complications and oncological efficacy did not differ between laparoscopic gastrectomy and open gastrectomy.

Factors influencing health-related quality of life after gastrectomy for cancer.

AIM: Insight in health-related quality of life (HRQoL) may improve clinical decision making and inform patients about the long-term effects of gastrectomy. This study aimed to evaluate and identify factors associated with HRQoL after gastrectomy. METHODS: This cross-sectional study used prospective databases from seven Dutch centers (2001-2015) including patients who underwent gastrectomy for cancer. Between July 2015 and November 2016, European Organization for Research and Treatment of Cancer HRQoL questionnaires QLQ-C30 and QLQ-STO22 were sent to all surviving patients without recurrence. The QLQ-C30 scores were compared to a Dutch reference population using a one-sample t test. Spearman's rank test was used to correlate time after surgery to HRQoL, and multivariable linear regression was performed to identify factors associated with HRQoL. RESULTS: A total of 222 of 274 (81.0%) patients completed the questionnaires. Median follow-up was 29 months (range, 3-171) and 86.9% of patients had a follow-up >1 year. The majority of patients had undergone neoadjuvant treatment (64.4%) and total gastrectomy (52.7%). Minimally invasive gastrectomy (MIG) was performed in 50% of the patients. Compared to the general population, gastrectomy patients scored significantly worse on most functional and symptom scales (p < 0.001) and slightly worse on global HRQoL (78 vs. 74, p = 0.012). Time elapsed since surgery did not correlate with global HRQoL (Spearman's ρ = 0.06, p = 0.384). Distal gastrectomy, neoadjuvant treatment, and MIG were associated with better HRQoL (p < 0.050). CONCLUSION: After gastrectomy, patients encounter functional impairments and symptoms, but experience only a slightly impaired global HRQoL. Distal gastrectomy, the ability to receive neoadjuvant treatment, and MIG may be associated with HRQoL benefits.

Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes.

OBJECTIVES: Aim of this study was to assess the prevalence of sarcopenia and body composition (i.e., subcutaneous and visceral fat) in gastric cancer surgical patients and its association with adverse postoperative outcome. METHODS: Preoperative CT scans were obtained from all patients who underwent surgery for gastric adenocarcinoma between January 2005 and September 2012. Total muscle and adipose tissue cross-sectional area were measured at the level of the third lumbar vertebra (L3) transverse processes. Sarcopenia was defined according to gender- and body mass index (BMI)-specific cutoff points. Primary outcome was in-hospital mortality. Secondary outcomes were severe postoperative complications (i.e., Clavien-Dindo classification ≥3a complications) and 6-month mortality. RESULTS: In 152 out of a total of 180 (84.4%) patients, a CT-scan was available for analysis. In total, 86 (57.7%) of the patients were classified as sarcopenic. Sarcopenia was no predictor for in-hospital mortality (P = 0.52), severe complications (P = 1.00) or 6-month mortality (P = 0.69). Intraabdominal and subcutaneous adipose tissue measurements were not associated with in-hospital mortality, severe complications or 6-month mortality. CONCLUSIONS: In this population of gastric cancer surgical patients, the prevalence of sarcopenia was 57.7%, which is high compared to other abdominal surgical oncology populations. However, sarcopenia was not associated with postoperative morbidity or mortality.

First experiences with the Radial Reload with Tri-staple™ technology in low rectal surgery.

INTRODUCTION: Low rectal surgery remains challenging. New surgical stapler devices have been developed to counteract problems of impaired visibility and inability to get low into the pelvis. One of them is the Radial Reload (RR) with Tri-staple(™) Technology (Covidien, New Haven, CT, USA). The aim of this study was to assess the first impressions and experiences regarding handling of this new stapler device in low anterior resection procedures in living humans. METHODS: A questionnaire, consisting of 27 statements concerning accessibility, maneuverability and visibility, was sent to 35 surgeons worldwide. RESULTS: A total of 85 rectal surgical procedures, both open and laparoscopic, were assessed by 31 surgeons. In 97% of the procedures the surgeons agreed that the RR stapler device facilitated access in the low pelvis. The first stapler device firing achieved complete transection in 54% of the procedures. According to the surgeons' assessments, in 91% percent of the procedures the RR stapler device enabled creation of adequate margins. Visualization of the pelvic floor was reported in 93% of the procedures. In the surgeons' opinion, the RR stapler device was considered clinically acceptable in 93% of the procedures. In 79% of the procedures the surgeon preferred the RR stapler device over the stapler device they normally used. CONCLUSION: This study showed that the first experiences with the RR stapler device of 33 surgeons in 85 low rectal procedures are positive. It facilitates low stapling in both open and laparoscopic procedures. Good visibility, maneuverability and the possibility to create adequate distal margins were reported.

Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery.

OBJECTIVE: To determine the association of sarcopenia with postoperative morbidity and mortality after colorectal surgery. BACKGROUND: Functional compromise in elderly colorectal surgical patients is considered as a significant factor of impaired postoperative recovery. Therefore, the predictive value of preoperative functional compromise assessment was investigated. Sarcopenia is a hallmark of functional compromise. METHODS: A total of 310 consecutive patients who underwent oncologic colorectal surgery were included in a prospective digital database. Sarcopenia was assessed using the L3 muscle index utilizing Osirix on preoperative computed tomography. Groningen Frailty Indicator and Short Nutritional Assessment Questionnaire scores were used to assess frailty and nutritional compromise. Predictors for anastomotic leakage, sepsis, and mortality were analyzed by logistic regression analysis. RESULTS: Age was an independent predictor of mortality [P = 0.04; odds ratio, 1.17; 95% confidence interval (CI), 1.01-1.37]. Thirty-day/in-hospital mortality rate in sarcopenic patients was 8.8% versus 0.7% in nonsarcopenic patients (P = 0.001; odds ratio, 15.5; 95% CI, 2.00-120). Sarcopenia was not predictive for anastomotic leakage or sepsis. Combination of high Short Nutritional Assessment Questionnaire score, high Groningen Frailty Indicator score, and sarcopenia strongly predicted sepsis (P = 0.001; odds ratio, 25.1; 95% CI, 5.11-123), sensitivity, 46%; specificity, 97%; positive likelihood ratio, 13 (95% CI, 4.4-38); negative likelihood ratio, 0.57 (95% CI, 0.33-0.97). CONCLUSIONS: Functional compromise in colorectal cancer surgery is associated with adverse postoperative outcome. Assessment of functional compromise by means of a nutritional questionnaire (Short Nutritional Assessment Questionnaire), a frailty questionnaire (Groningen Frailty Indicator), and sarcopenia measurement (L3 muscle index) can accurately predict postoperative sepsis.

Improving the outcomes in gastric cancer surgery.

Gastric cancer remains a significant health problem worldwide and surgery is currently the only potentially curative treatment option. Gastric cancer surgery is generally considered to be high risk surgery and five-year survival rates are poor, therefore a continuous strive to improve outcomes for these patients is warranted. Fortunately, in the last decades several potential advances have been introduced that intervene at various stages of the treatment process. This review provides an overview of methods implemented in pre-, intra- and postoperative stage of gastric cancer surgery to improve outcome. Better preoperative risk assessment using comorbidity index (e.g., Charlson comorbidity index), assessment of nutritional status (e.g., short nutritional assessment questionnaire, nutritional risk screening - 2002) and frailty assessment (Groningen frailty indicator, Edmonton frail scale, Hopkins frailty) was introduced. Also preoperative optimization of patients using prehabilitation has future potential. Implementation of fast-track or enhanced recovery after surgery programs is showing promising results, although future studies have to determine what the exact optimal strategy is. Introduction of laparoscopic surgery has shown improvement of results as well as optimization of lymph node dissection. Hyperthermic intraperitoneal chemotherapy has not shown to be beneficial in peritoneal metastatic disease thus far. Advances in postoperative care include optimal timing of oral diet, which has been shown to reduce hospital stay. In general, hospital volume, i.e., centralization, and clinical audits might further improve the outcome in gastric cancer surgery. In conclusion, progress has been made in improving the surgical treatment of gastric cancer. However, gastric cancer treatment is high risk surgery and many areas for future research remain.

Value of geriatric frailty and nutritional status assessment in predicting postoperative mortality in gastric cancer surgery.

OBJECTIVES: This study seeks to evaluate assessment of geriatric frailty and nutritional status in predicting postoperative mortality in gastric cancer surgery. METHODS: Preoperatively, patients operated for gastric adenocarcinoma underwent assessment of Groningen Frailty Indicator (GFI) and Short Nutritional Assessment Questionnaire (SNAQ). We studied retrospectively whether these scores were associated with in-hospital mortality. RESULTS: From 2005 to September 2012 180 patients underwent surgery with an overall mortality of 8.3%. Patients with a GFI ≥ 3 (n = 30, 24%) had a mortality rate of 23.3% versus 5.2% in the lower GFI group (OR 4.0, 95%CI 1.1-14.1, P = 0.03). For patients who underwent surgery with curative intent (n = 125), this was 27.3% for patients with GFI ≥ 3 (n = 22, 18%) versus 5.7% with GFI < 3 (OR 4.6, 95% CI 1.0-20.9, P = 0.05). SNAQ ≥ 1 (n = 98, 61%) was associated with a mortality rate of 13.3% versus 3.2% in patients with SNAQ =0 (OR 5.1, 95% CI 1.1-23.8, P = 0.04). Given odds ratios are corrected in multivariate analyses for age, neoadjuvant chemotherapy, type of surgery, tumor stage and ASA classification. CONCLUSIONS: This study shows a significant relationship between gastric cancer surgical mortality and geriatric frailty as well as nutritional status using a simple questionnaire. This may have implications in preoperative decision making in selecting patients who optimally benefit from surgery.