Hyperbaric bupivacaine versus prilocaine for spinal anesthesia combined with total intravenous anesthesia during oncological colon surgery in a 23-hour stay enhanced recovery protocol: A non-randomized study.

After the success of the enhanced recovery after surgery protocol, perioperative care has been further optimized in accelerated enhanced recovery pathways (ERPs), where optimal pain management is crucial. Spinal anesthesia was introduced as adjunct to general anesthesia to reduce postoperative pain and facilitate mobility. This study aimed to determine which spinal anesthetic agent provides best pain relief in accelerated ERP for colon carcinoma. This single center study was a secondary analysis conducted among patients included in the aCcelerated 23-Hour erAS care for colon surgEry study who underwent elective laparoscopic colon surgery. The first 30 patients included received total intravenous anesthesia combined with spinal anesthesia with prilocaine, the 30 patients subsequently included received spinal anesthesia with hyperbaric bupivacaine. Primary endpoint of this study was the total amount of morphine milligram equivalents (MMEs) administered during hospital stay. Secondary outcomes were amounts of MMEs administered in the recovery room and surgical ward, pain score using the numeric rating scale, complication rates and length of hospital stay. Compared to prilocaine, the total amount of MMEs administered was significantly lower in the bupivacaine group (n = 60, 16.3 vs 6.3, P = .049). Also, the amount of MMEs administered and median pain scores were significantly lower after intrathecal bupivacaine in the recovery room (MMEs 11.0 vs 0.0, P = .012 and numeric rating scale 2.0 vs 1.5, P = .004). On the surgical ward, median MMEs administered, and pain scores were comparable. Postoperative outcomes were similar in both groups. Spinal anesthesia with hyperbaric bupivacaine was associated with less opioid use and better pain reduction immediately after surgery compared to prilocaine within an accelerated ERP for elective, oncological colon surgery.

Views and experiences of healthcare professionals and patients on the implementation of a 23-hour accelerated enhanced recovery programme: a mixed-method study.

BACKGROUND: An accumulating body of research suggests that an accelerating enhanced recovery after colon surgery protocol is beneficial for patients, however, to obtain these effects, adherence to all elements of the protocol is important. The implementation of complex interventions, such as the Enhanced Recovery After Surgery protocol (ERAS), and their strict adherence have proven to be difficult. The same challenges can be expected in the implementation of the accelerated Enhanced Recovery Pathways (ERPs). This study aimed to understand the perspectives of both healthcare professionals (HCPs) and patients on the locally studied acCelerated enHanced recovery After SurgEry (CHASE) protocol. METHODS: For this mixed-method study, HCPs who provided CHASE care and patients who received CHASE care were recruited using purposive sampling. Ethical approval was obtained by the Medical Ethical Committee of the Zuyderland Medical Centre (NL71804.096.19, METCZ20190130, October 2022). Semi-structured, in-depth, one-on-one interviews were conducted with HCPs (n = 13) and patients (n = 11). The interviews consisted of a qualitative and quantitative part, the protocol evaluation and the Measurement Instrument or Determinant of Innovations-structured questionnaire. We explored the perspectives, barriers, and facilitators of the CHASE protocol implementation. The interviews were audiotaped, transcribed verbatim and analysed independently by two researchers using direct content analysis. RESULTS: The results showed that overall, HCPs support the implementation of the CHASE protocol. The enablers were easy access to the protocol, the relevance of the intervention, and thorough patient education. Some of the reported barriers included the difficulty of recognizing CHASE patients, the need for regular feedback, and the updates on the implementation progress. Most patients were enthusiastic about early discharge after surgery and expressed satisfaction with the care they received. On the other hand, the patients sometimes received different information from different HCPs, considered the information to be too extensive and few experienced some discomfort with CHASE care. CONCLUSION: Bringing CHASE care into practice was challenging and required adaptation from HCPs. The experiences of HCPs showed that the protocol can be improved further, and the mostly positive experiences of patients are a motivation for this improvement. These results yielded practical implications to improve the implementation of accelerated ERPs.

Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

Accelerated enhanced recovery after colon cancer surgery with discharge within one day after surgery: a systematic review.

BACKGROUND: Recent studies have demonstrated that accelerated enhanced recovery after colorectal surgery is feasible for specific patient populations. The accelerated enhanced recovery protocols (ERP) tend to vary, and the majority of studies included a small study population. This hampers defining the optimal protocol and establishing the potential benefits. This systematic review aimed to determine the effect of accelerated ERPs with intended discharge within one day after surgery. METHODS: PubMed (MEDLINE), Embase, Cochrane and Web of Science databases were searched using the following search terms: colon cancer, colon surgery, accelerated recovery, fast track recovery, enhanced recovery after surgery. Clinical trials published between January 2005 - February 2023, written in English or Dutch comparing accelerated ERPs to Enhanced Recovery After Surgery (ERAS) care for adult patients undergoing elective laparoscopic or robotic surgery for colon cancer were eligible for inclusion. RESULTS: Thirteen studies, including one RCT were included. Accelerated ERPs after colorectal surgery was possible as LOS was shorter; 14 h to 3.4 days, and complication rate varied from 0-35.7% and readmission rate was 0-17% in the accelerated ERP groups. Risk of bias was serious or critical in most of the included studies. CONCLUSIONS: Accelerated ERPs may not yet be considered the new standard of care as the current data is heterogenous, and data on important outcome measures is scarce. Nonetheless, the decreased LOS suggests that accelerated recovery is possible for selected patients. In addition, the complication and readmission rates were comparable to ERAS care, suggesting that accelerated recovery could be safe.

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 Comprehensive Complication Index versus Clavien-Dindo grading after laparoscopic and open D2-gastrectomy in the multicenter randomized LOGICA-trial.

BACKGROUND: Complications can be classified using the most-severe Clavien-Dindo-Classification (CDC) per patient or the total complication burden per patient expressed in the Comprehensive Complication Index (CCI). This study determined the additional value of CCI to CDC in examining the impact of complications after gastric cancer surgery. METHODS: The CCI and CDC were determined in the multicenter randomized LOGICA-trial comparing laparoscopic versus open D2-gastrectomy for cancer (cT1-4aN0-3M0). Differences in median CCI between laparoscopic and open gastrectomy were compared for overall postoperative complications and cardiovascular, gastrointestinal, infectious, pulmonary, and other complications. CCI and CDC were correlated to hospitalization, ICU-stay and reoperations using Spearman's rho-test and compared with standard Fisher's z-transformation. RESULTS: Between 2015 and 2018, 211 patients underwent laparoscopic (n = 106) or open (n = 105) D2-gastrectomy, and 157 (74%) received neoadjuvant chemotherapy. Median CCI was comparable between laparoscopic versus open gastrectomy regarding overall complications (CCI 0 [IQR 0-23.5] versus 0 [IQR 0-22.6]; p = 0.755) and subgroups of complications (p > 0.05). Both CCI and CDC showed moderate positive correlations for hospitalization (rs = 0.646 versus rs = 0.628; p = 0.001, difference clinically irrelevant), and reoperations (rs = 0.590 versus rs = 0.599; p = 0.070), and weak correlations for ICU-stay (rs = 0.446 versus rs = 0.440; p = 0.189). CONCLUSIONS: The CCI is a composite scoring system based on the CDC and reflects a subjective interpretation of complication burden from the perspectives of both physicians and patients, following abdominal surgery other than gastrectomy. Implementing CCI showed no clinically relevant benefit and caused additional workload compared to CDC for assessing complication burden. Therefore, using the CCI alongside the CDC after gastric cancer surgery is not recommended.

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.

Distal Versus Total D2-Gastrectomy for Gastric Cancer: a Secondary Analysis of Surgical and Oncological Outcomes Including Quality of Life in the Multicenter Randomized LOGICA-Trial.

BACKGROUND: Distal gastrectomy (DG) for gastric cancer can cause less morbidity than total gastrectomy (TG), but may compromise radicality. No prospective studies administered neoadjuvant chemotherapy, and few assessed quality of life (QoL). METHODS: The multicenter LOGICA-trial randomized laparoscopic versus open D2-gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0) in 10 Dutch hospitals. This secondary LOGICA-analysis compared surgical and oncological outcomes after DG versus TG. DG was performed for non-proximal tumors if R0-resection was deemed achievable, TG for other tumors. Postoperative complications, mortality, hospitalization, radicality, nodal yield, 1-year survival, and EORTC-QoL-questionnaires were analyzed using Χ2-/Fisher's exact tests and regression analyses. RESULTS: Between 2015 and 2018, 211 patients underwent DG (n = 122) or TG (n = 89), and 75% of patients underwent neoadjuvant chemotherapy. DG-patients were older, had more comorbidities, less diffuse type tumors, and lower cT-stage than TG-patients (p < 0.05). DG-patients experienced fewer overall complications (34% versus 57%; p < 0.001), also after correcting for baseline differences, lower anastomotic leakage (3% versus 19%), pneumonia (4% versus 22%), atrial fibrillation (3% versus 14%), and Clavien-Dindo grading compared to TG-patients (p < 0.05), and demonstrated shorter median hospital stay (6 versus 8 days; p < 0.001). QoL was better after DG (statistically significant and clinically relevant) in most 1-year postoperative time points. DG-patients showed 98% R0-resections, and similar 30-/90-day mortality, nodal yield (28 versus 30 nodes; p = 0.490), and 1-year survival after correcting for baseline differences (p = 0.084) compared to TG-patients. CONCLUSIONS: If oncologically feasible, DG should be preferred over TG due to less complications, faster postoperative recovery, and better QoL while achieving equivalent oncological effectiveness. Distal D2-gastrectomy for gastric cancer resulted in less complications, shorter hospitalization, quicker recovery and better quality of life compared to total D2-gastrectomy, whereas radicality, nodal yield and survival were similar.

Learning Curve of Laparoscopic Gastrectomy: A Multicenter Study.

OBJECTIVE: To evaluate the learning curve of laparoscopic gastrectomy (LG) after an implementation program. BACKGROUND: Although LG is increasingly being performed worldwide, little is known about the learning curve. METHODS: Consecutive patients who underwent elective LG for gastric adenocarcinoma with curative intent in each of the 5 highest-volume centers in the Netherlands were enrolled. Generalized additive models and a 2-piece model with a break point were used to determine the learning curve length. Analyses were corrected for casemix and were performed for LG and for the subgroups distal gastrectomy (LDG) and total gastrectomy (LTG). The learning curve effect was assessed for (1) anastomotic leakage; and (2) the occurrence of postoperative complications, conversions to open surgery, and short-term oncological parameters. RESULTS: In total 540 patients were included for analysis, 108 patients from each center; 268 patients underwent LDG and 272 underwent LTG. First, for LG, no learning effect regarding anastomotic leakage could be identified: the rate of anastomotic leakage initially increased, then reached a plateau after 36 cases at 10% anastomotic leakage. Second, the level of overall complications reached a plateau after 20 cases, at 38% overall complications, and at 5% conversions. For both LDG and LTG, each considered separately, fluctuations in secondary outcomes and anastomotic leakage followed fluctuations in casemix. CONCLUSION: On the basis of our study of the first 108 procedures of LG in 5 high-volume centers with well-trained surgeons, no learning curve effect could be identified regarding anastomotic leakage. A learning curve effect was found with respect to overall complications and conversion rate.

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.

Accelerated 23-h enhanced recovery protocol for colon surgery: the CHASE-study.

The introduction of the Enhanced Recovery After Surgery (ERAS) program has radically improved postoperative outcomes in colorectal surgery. Optimization of ERAS program to an accelerated recovery program may further improve these said outcomes. This single-center, prospective study investigated the feasibility and safety of a 23-h accelerated enhanced recovery protocol (ERP) for colorectal cancer patients (ASA I-II) undergoing elective laparoscopic surgery. The 23-h accelerated ERP consisted of adjustments in pre-, peri- and postoperative care; this was called the CHASE-protocol. This group was compared to a retrospective cohort of colorectal cancer patients who received standard ERAS care. Patients were discharged within 23 h after surgery if they met the discharge criteria. Primary outcome was the rate of the successful discharge within 23 h. Successful discharge within the CHASE-cohort was realized in 33 out of the 41 included patients (80.5%). Compared to the retrospective cohort (n = 75), length of stay was significantly shorter in the CHASE-cohort (p = 0.000), and the readmission rate was higher (p = 0.051). Complication rate was similar, severe complications were observed less frequently in the CHASE-cohort (4.9% vs. 8.0%). Findings from this study support the feasibility and safety of the accelerated 23-h accelerated ERP with the CHASE-protocol in selected patients.

Pattern of lymph node metastases in gastric cancer: a side-study of the multicenter LOGICA-trial.

BACKGROUND: The relation between gastric cancer characteristics and lymph node (LN) metastatic patterns is not fully clear, especially following neoadjuvant chemotherapy (NAC). This study analyzed nodal metastatic patterns. METHODS: Individual LN stations were analyzed for all patients from the LOGICA-trial, a Dutch multicenter randomized trial comparing laparoscopic versus open D2-gastrectomy for gastric cancer. The pattern of metastases per LN station was related to tumor location, cT-stage, Lauren classification and NAC. RESULTS: Between 2015-2018, 212 patients underwent D2-gastrectomy, of whom 158 (75%) received NAC. LN metastases were present in 120 patients (57%). Proximal tumors metastasized predominantly to proximal LN stations (no. 1, 2, 7 and 9; p < 0.05), and distal tumors to distal LN stations (no. 5, 6 and 8; OR > 1, p > 0.05). However, distal tumors also metastasized to proximal LN stations, and vice versa. Despite NAC, each LN station (no. 1-9, 11 and 12a) showed metastases, regardless of tumor location, cT-stage, histological subtype and NAC treatment, including station 12a for cT1N0-tumors. LN metastases were present more frequently in diffuse versus intestinal tumors (66% versus 52%; p = 0,048), but not for cT3-4- versus cT1-2-stage (59% versus 51%; p = 0.259). However, the pattern of LN metastases was similar for these subgroups. CONCLUSIONS: The extent of lymphadenectomy cannot be reduced after NAC for gastric cancer. Although the pattern of LN metastases is related to tumor location, all LN stations contained metastases regardless of tumor location, cT-stage (including cT1N0-tumors), histological subtype, or NAC treatment. Therefore, D2-lymphadenectomy should be routinely performed during gastrectomy in Western patients.

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.

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program.

Prehabilitation has been postulated as an effective preventive intervention to reduce postoperative complications, particularly for elderly patients with a relatively high risk of complications. To date, it remains to be determined whether prehabilitation increases physical capacity and reduces postoperative complications. The aim of this study was to assess the feasibility of a 4-week multimodal prehabilitation program consisting of a personalized, supervised training program and nutritional intervention with daily fresh protein-rich food for colorectal cancer patients aged over 64 years prior to surgery. The primary outcome was the feasibility of this prehabilitation program defined as ≥80% compliance with the exercise training program and nutritional intervention. The secondary outcomes were the organizational feasibility and acceptability of the prehabilitation program. A compliance rate of ≥80% to both the exercise and nutritional intervention was accomplished by 6 patients (66.7%). Attendance of ≥80% at all 12 training sessions was achieved by 7 patients (77.8%); all patients (100%) attended ≥80% of the available training sessions. Overall, compliance with the training was 91.7%. Six patients (66.7%) accomplished compliance of ≥80% with the nutritional program. The median protein intake was 1.2 (g/kg/d). No adverse events occurred. This multimodal prehabilitation program was feasible for the majority of patients.

18F-Fludeoxyglucose-Positron Emission Tomography/Computed Tomography and Laparoscopy for Staging of Locally Advanced Gastric Cancer: A Multicenter Prospective Dutch Cohort Study (PLASTIC).

Importance: The optimal staging for gastric cancer remains a matter of debate. Objective: To evaluate the value of 18F-fludeoxyglucose-positron emission tomography with computed tomography (FDG-PET/CT) and staging laparoscopy (SL) in addition to initial staging by means of gastroscopy and CT in patients with locally advanced gastric cancer. Design, Setting, and Participants: This multicenter prospective, observational cohort study included 394 patients with locally advanced, clinically curable gastric adenocarcinoma (≥cT3 and/or N+, M0 category based on CT) between August 1, 2017, and February 1, 2020. Exposures: All patients underwent an FDG-PET/CT and/or SL in addition to initial staging. Main Outcomes and Measures: The primary outcome was the number of patients in whom the intent of treatment changed based on the results of these 2 investigations. Secondary outcomes included diagnostic performance, number of incidental findings on FDG-PET/CT, morbidity and mortality after SL, and diagnostic delay. Results: Of the 394 patients included, 256 (65%) were men and mean (SD) age was 67.6 (10.7) years. A total of 382 patients underwent FDG-PET/CT and 357 underwent SL. Treatment intent changed from curative to palliative in 65 patients (16%) based on the additional FDG-PET/CT and SL findings. FDG-PET/CT detected distant metastases in 12 patients (3%), and SL detected peritoneal or locally nonresectable disease in 73 patients (19%), with an overlap of 7 patients (2%). FDG-PET/CT had a sensitivity of 33% (95% CI, 17%-53%) and specificity of 97% (95% CI, 94%-99%) in detecting distant metastases. Secondary findings on FDG/PET were found in 83 of 382 patients (22%), which led to additional examinations in 65 of 394 patients (16%). Staging laparoscopy resulted in a complication requiring reintervention in 3 patients (0.8%) without postoperative mortality. The mean (SD) diagnostic delay was 19 (14) days. Conclusions and Relevance: This study's findings suggest an apparently limited additional value of FDG-PET/CT; however, SL added considerably to the staging process of locally advanced gastric cancer by detection of peritoneal and nonresectable disease. Therefore, it may be useful to include SL in guidelines for staging advanced gastric cancer, but not FDG-PET/CT.

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.

Reducing hospital stay for colorectal surgery in ERAS setting by means of perioperative patient education of expected day of discharge.

PURPOSE: Despite the enhanced recovery after surgery (ERAS) protocol, length of stay (LOS) after colorectal surgery varies considerably. The majority of longer admissions is often not medically necessary. We aimed to investigate possible reduction of LOS by perioperative education with an expected discharge date (EDD). METHODS: This single-centre retrospective study included 578 patients who underwent surgery for colorectal cancer in 2016 with standard care (ERAS) and in 2018 with the addition of EDD education program (ERAS+). A comparison was made of a 1-year period prior to and following the implementation of EDD. The EDD was discussed at the outpatient clinic, preoperatively and during admission (with both the patient and family members daily). Standard EDD varied between 3 and 5 days depending on the resection type. Primary outcome was LOS; secondary outcomes were readmission, serious complications and 90-day mortality. RESULTS: Patients in ERAS+ (n = 242) had a shorter median LOS (4.0 vs. 5.0, p < 0.001) compared to patients in the regular ERAS group (n = 336). Fewer patients of ERAS+ experienced postoperative complications (71 (29.3%) vs. 198 (58.9%), p < 0.001). No difference was found in the number of readmissions (23 (9.5%) vs. 34 (10.1%), p = 0.807), reinterventions (25 (10.3%) vs. 30 (8.9%), p = 0.571) or mortality (5 (2.1%) vs. 9 (2.7%), p = 0.261) between the two groups. CONCLUSION: It is possible to reduce LOS within the ERAS program, by better perioperative education and expectation management of patients with use of an EDD. This program ensures better understanding, faster discharge and lower costs for the hospital without added risk of readmissions or complications.

The Introduction of Laparoscopic Colorectal Surgery: Can It Improve Hospital Economics?

INTRODUCTION: Clinical benefits of laparoscopic surgery are well established, but evidence for financial benefits is limited. This study aimed to compare the financial impact of the introduction of laparoscopic colorectal surgery. METHODS: This study included patients who underwent colorectal surgery between January 2010 and 2015. We collected a range of financial data and divided the patients into 2 groups. Primary outcome was total cost defined by surgical-related costs. RESULTS: A total of 1,246 patients were included, of which 440 surgeries were performed laparoscopically. The total median cost of laparoscopy was higher compared to open surgery (EUR 4,665 vs. EUR 4,268, p = 0.001). Laparoscopy was associated with higher equipment costs (EUR 857 vs. EUR 232, p < 0.001), longer operating time (3.2 vs. 2.5 hours, p < 0.001), and more readmissions (10.9 vs. 8.5%, p < 0.001). However, after adjusting for heterogeneity, no difference was found in total cost. Surgical-related costs were counterbalanced by lower costs associated with shorter median hospital stay (6 vs. 9 days, p < 0.001), less morbidity (37.3 vs. 55.1%, p < 0.001), and less mortality (1.8 vs. 5.6%, p = 0.013) for laparoscopy. CONCLUSION: During the introduction of laparoscopy for colorectal surgery, no significant differences were found in total cost between laparoscopic and open colorectal surgery. However, favorable postoperative outcomes were achieved with laparoscopic surgery.

Oncological Outcomes and Hospital Costs of the Treatment in Patients With Rectal Cancer: Watch-and-Wait Policy and Standard Surgical Treatment.

BACKGROUND: Little is known about the costs of the current treatment strategy in locally advanced rectal cancer, in which patients with a clinical complete response after chemoradiotherapy are treated in a watch-and-wait policy. OBJECTIVE: The aim of this study is to present the oncological outcome and hospital costs of patients with a complete response after chemoradiotherapy (watch-and-wait policy) and patients with an incomplete response after chemoradiotherapy (total mesorectal excision). DESIGN: This was a cohort study. SETTINGS: This study was conducted at an academic and a nonacademic hospital. PATIENTS: Patients with locally advanced rectal cancer received either a watch-and-wait policy or total mesorectal excision depending on their clinical response to chemoradiotherapy. INTERVENTIONS: Watch-and-wait policy and total mesorectal excision were the treatments applied. MAIN OUTCOME MEASURES: The primary outcomes measured were overall, local recurrence-free, and distant metastasis-free survival and hospital costs over a 2-year follow-up period. RESULTS: A total of 292 patients with locally advanced rectal cancer were included. Mean age was 65.1 years, and 64.7% were men. One hundred five patients were included in the watch-and-wait subgroup, and 187 patients were in the total mesorectal excision subgroup. Both subgroups showed good oncological outcomes. Hospital costs consisted of 5 categories: costs of primary surgery, costs of adjuvant chemotherapy, costs of examinations, costs of additional surgery, and costs of treatment of regrowth/metastasis. The mean costs per patient were &OV0556;6713 (watch-and-wait subgroup) and &OV0556;17,108 (total mesorectal excision subgroup) over the first 2 years. LIMITATIONS: This study was limited by the following: costs were only from a hospital perspective, follow-up was 2 years, the study was retrospective in part, and there was no comparative study. CONCLUSIONS: Overall survival was good in both subgroups and comparable to literature. The mean costs per patient differ between the watch-and-wait subgroup (&OV0556;6713) and the total mesorectal excision subgroup (&OV0556;17,108). No comparison between the groups could be made. Based on the results of this study, the current strategy, where patients with a clinical complete response are treated in a watch-and-wait policy, and patients with an incomplete response are treated with total mesorectal excision, is likely to be (cost)saving. See Video Abstract at http://links.lww.com/DCR/B177. RESULTADOS ONCOLÓGICOS Y COSTOS HOSPITALARIOS EN EL TRATAMIENTO DE PACIENTES CON CANCER DE RECTO: ACTITUD DE ESPERA-VIGILANCIA Y TRATAMIENTO QUIRÚRGICO ESTANDARD: Se sabe poco sobre el costo del tratamiento actual en casos de cancer de recto localmente avanzado, cuando se aplica una política de vigilancia y espera en aquellos pacientes que presentan una respuesta clínica completa después de radio-quimioterapia.El propósito final del presente estudio es dar a conocer el resultado oncológico y los costos hospitalarios de los pacientes que presentan una respuesta clínica completa después de radio-quimioterapia (actitud de vigilancia-espera) y los pacientes con una respuesta incompleta después luego de radio-quimioterapia (excisión total del mesorrecto-ETM).Estudio de cohortes.Hospitales académicos y no académicos.Todos aquellos pacientes tratados por un cáncer de recto localmente avanzado y que fueron seguidos con una política de vigilancia y espera o la ETM, en función de la respuesta clínica a la radio-quimioterapia.Políticas de vigilancia-espera, excisión total del mesorrecto.Sobrevida global libre de recurrencia local, metástasis a distancia, sobrevida libre de enfermedad y costos hospitalarios durante un período de seguimiento de dos años.Se incluyeron 292 pacientes diagnosticados de cancer de recto localmente avanzado. La edad media fue de 65,1 años, 64,7% eran de sexo masculino. Se incluyeron 105 pacientes en el subgrupo de vigilancia-espera, y 187 en el subgrupo de excisión total del mesorrecto. Ambos subgrupos mostraron optimos resultados oncológicos. Los costos hospitalarios se dividieron en cinco categorías: costos de cirugía primaria; costos de quimioterapia adyuvante; costos de exámenes; costos de cirugía adicional; y costos del tratamiento de rebrote / metástasis. Los costos medios por paciente fueron de &OV0556; 6.713 (subgrupo de espera-vigilancia) y &OV0556; 17.108 (subgrupo de excisión total del mesorrecto) durante los primeros dos años.Analisis de costos desde una perspectiva hospitalaria durante un seguimiento de dos años, estudio parcialmente retrospectivo, no comparativo.La sobrevida general fue optima en ambos subgrupos y comparable con la literatura. El costo promedio por paciente difiere entre el subgrupo de vigilancia y espera (&OV0556; 6.713) con el subgrupo de la ETM(&OV0556; 17.108). No se pudieron comparar definitivamente ambos grupos. Basados en los resultados del presente estudio, es probable que la estrategia actual, en la que los pacientes con respuesta clínica completa sean tratados con una política de vigilancia y espera, presenten muy probablemente un cierto ahorro en el costo con relación a los pacientes con una respuesta incompleta tratados con excisión total del mesorrecto. Consulte Video Resumen en http://links.lww.com/DCR/B177. (Traducción-Dr. Xavier Delgadillo).