Myeloid-derived suppressor cells in peripheral blood as predictive biomarkers in patients with solid tumors undergoing immune checkpoint therapy: systematic review and meta-analysis.

Background: Immunotherapeutic approaches, including immune checkpoint inhibitor (ICI) therapy, are increasingly recognized for their potential. Despite notable successes, patient responses to these treatments vary significantly. The absence of reliable predictive and prognostic biomarkers hampers the ability to foresee outcomes. This meta-analysis aims to evaluate the predictive significance of circulating myeloid-derived suppressor cells (MDSC) in patients with solid tumors undergoing ICI therapy, focusing on progression-free survival (PFS) and overall survival (OS). Methods: A comprehensive literature search was performed across PubMed and EMBASE from January 2007 to November 2023, utilizing keywords related to MDSC and ICI. We extracted hazard ratios (HRs) and 95% confidence intervals (CIs) directly from the publications or calculated them based on the reported data. A hazard ratio greater than 1 indicated a beneficial effect of low MDSC levels. We assessed heterogeneity and effect size through subgroup analyses. Results: Our search yielded 4,023 articles, of which 17 studies involving 1,035 patients were included. The analysis revealed that patients with lower levels of circulating MDSC experienced significantly improved OS (HR=2.13 [95% CI 1.51-2.99]) and PFS (HR=1.87 [95% CI 1.29-2.72]) in response to ICI therapy. Notably, heterogeneity across these outcomes was primarily attributed to differences in polymorphonuclear MDSC (PMN-MDSC) subpopulations and varying cutoff methodologies used in the studies. The monocytic MDSC (M-MDSC) subpopulation emerged as a consistent and significant prognostic marker across various subgroup analyses, including ethnicity, tumor type, ICI target, sample size, and cutoff methodology. Conclusions: Our findings suggest that standardized assessment of MDSC, particularly M-MDSC, should be integral to ICI therapy strategies. These cells hold the promise of identifying patients at risk of poor response to ICI therapy, enabling tailored treatment approaches. Further research focusing on the standardization of markers and validation of cutoff methods is crucial for integrating MDSC into clinical practice. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023420095, identifier CRD42023420095.

Remote ischemic preconditioning versus sham-control for prevention of anastomotic leakage after resection for rectal cancer (RIPAL trial): a pilot randomized controlled, triple-blinded monocenter trial.

PURPOSE: Remote ischemic preconditioning (RIPC) reportedly reduces ischemia‒reperfusion injury (IRI) in various organ systems. In addition to tension and technical factors, ischemia is a common cause of anastomotic leakage (AL) after rectal resection. The aim of this pilot study was to investigate the potentially protective effect of RIPC on anastomotic healing and to determine the effect size to facilitate the development of a subsequent confirmatory trial. MATERIALS AND METHODS: Fifty-four patients with rectal cancer (RC) who underwent anterior resection were enrolled in this prospectively registered (DRKS0001894) pilot randomized controlled triple-blinded monocenter trial at the Department of Surgery, University Medicine Mannheim, Mannheim, Germany, between 10/12/2019 and 19/06/2022. The primary endpoint was AL within 30 days after surgery. The secondary endpoints were perioperative morbidity and mortality, reintervention, hospital stay, readmission and biomarkers of ischemia‒reperfusion injury (vascular endothelial growth factor, VEGF) and cell death (high mobility group box 1 protein, HMGB1). RIPC was induced through three 10-min cycles of alternating ischemia and reperfusion to the upper extremity. RESULTS: Of the 207 patients assessed, 153 were excluded, leaving 54 patients to be randomized to the RIPC or the sham-RIPC arm (27 each per arm). The mean age was 61 years, and the majority of patients were male (37:17 (68.5:31.5%)). Most of the patients underwent surgery after neoadjuvant therapy (29/54 (53.7%)) for adenocarcinoma (52/54 (96.3%)). The primary endpoint, AL, occurred almost equally frequently in both arms (RIPC arm: 4/25 (16%), sham arm: 4/26 (15.4%), p = 1.000). The secondary outcomes were comparable except for a greater rate of reintervention in the sham arm (9 (6-12) vs. 3 (1-5), p = 0.034). The median duration of endoscopic vacuum therapy was shorter in the RIPC arm (10.5 (10-11) vs. 38 (24-39) days, p = 0.083), although the difference was not statistically significant. CONCLUSION: A clinically relevant protective effect of RIPC on anastomotic healing after rectal resection cannot be assumed on the basis of these data.

Motivational Interviewing improves postoperative nutrition goals within the Enhanced Recovery after Surgery (ERAS®) pathway in elective bowel surgery - A randomized clinical pilot trial.

BACKGROUND & AIMS: Exploration whether Motivational Interviewing (MI) could be learned and implemented with ease within a surgical in-hospital setting and whether participation in the intervention led to significantly higher compliance with ERAS®-recommended protein intake goals. The individual healing process of many patients is delayed because they fail to cover their calorie requirement, which could be counteracted by a patient-centered conversational intervention that is new in perioperative practice. METHODS: This patient-blinded pilot-RCT included 60 patients (≥18 years) following the certified ERAS® bowel protocol for colorectal surgery between March and August 2022. Five perioperative MI interventions were conducted by two health employees certified to perform MI. Key endpoints were the number of protein shakes drunk, calories of proteins ingested and overall calorie intake. RESULTS: A total of 60 patients (34 men [56.7%]; mean [SD] age, 60.7 [13.3] years) were randomized. MI patient-group had significantly higher protein shake intake on all postoperative days except day 3. For days 0-3 MI group drank significantly more shakes overall (median 5.5 vs. 2.0; P = 0.004) and consumed more calories (median 1650.0 vs. 600.0 kcal; P = 0.004) and proteins (median 110.0 vs. 40.0 g; P = 0.005). Total calorie intake for each day by shakes and dietary intake was significantly higher in the MI-intervention group on day 2 (mean 1772.3 vs. 1358.9 kcal; P = 0.03). CONCLUSIONS: MI may contribute to improve compliance with nutritional goals in the certified ERAS® protocol by increasing protein and calorie intake. The findings suggest further investigation of MI to help patients achieve their perioperative nutrition goals in different clinical settings. TRIAL REGISTRATION: DRKS - Deutsches Register Klinischer Studien; DRKS-ID: DRKS00027863; https://drks.de/search/de/trial/DRKS00027863.

Influence of motivational interviewing on postoperative mobilization in the enhanced recovery after surgery (ERAS®) pathway in elective colorectal surgery - a randomized patient-blinded pilot study.

PURPOSE: Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization. METHODS: This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count). RESULTS: 97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298). CONCLUSION: MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial. REGISTRATION: This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".

Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial.

BACKGROUND: Remote ischemic preconditioning reduces ischemia-reperfusion injury in patients undergoing hepatectomy. Moreover, there is evidence that the protective effects of remote ischemic preconditioning may be more pronounced in pre-damaged livers. The objective of this trial was to investigate the extent to which remote ischemic preconditioning can attenuate ischemia-reperfusion injury after hepatectomy and Pringle maneuver in patients with chronic liver disease. METHODS: In this randomized, controlled, triple-blind monocenter trial, a total of 102 patients with chronic liver disease and planned hepatectomy were enrolled between December 2019 and March 2022. Eligible patients were randomized to the remote ischemic preconditioning or sham arms. Remote ischemic preconditioning was induced through 3 10-minute cycles of alternating ischemia and reperfusion of the upper extremity. The study was prospectively registered in the German Clinical Trials Registry (DRKS00018931). RESULTS: A total of 102 patients were included in the study and were randomized (51 per arm). The median age was 69.5 years, approximately two-thirds of the patients were male (69/102, 67.7%), and the mean body mass index was 25.6 kg/m2. Most patients were classified as American Society of Anesthesiologists II (55/102, 53.9%) or III (45/102, 44.1%). The primary endpoint, the transaminases on the first postoperative day (alanine aminotransferase /aspartate aminotransferase: remote ischemic preconditioning arm: 250 (35-1721)/320 (42-1525) U/L versus sham control arm: 283 (32-792)/356 (20-1851) U/L, P = .820/0.639), clinical outcomes as well as remote ischemic preconditioning biomarker levels were comparable between both arms. CONCLUSION: Remote ischemic preconditioning did not achieve a significant reduction in postoperative transaminase levels, nor did it affect clinical results and biomarkers.

Adherence to fast track measures in colorectal surgery-a survey among German and Austrian surgeons.

PURPOSE: The effectiveness of modern perioperative treatment concepts has been demonstrated in several studies and meta-analyses. Despite good evidence, limited implementation of the fast track (FT) concept is still a widespread concern. To assess the status quo in Austrian and German hospitals, a survey on the implementation of FT measures was conducted among members of the German Society of General and Visceralsurgery (DGAV), the German Society of Coloproctology (DGK) and the Austrian Society of Surgery (OEGCH) to analyze where there is potential for improvement. METHODS: Twenty questions on perioperative care of colorectal surgery patients were sent to the members of the DGAV, DGK and OEGCH using the online survey tool SurveyMonkey®. Descriptive data analysis was performed using Microsoft Excel. RESULTS: While some of the FT measures have already been routinely adopted in clinical practice (e.g. minimally invasive surgical approach, early mobilization and diet buildup), for other components there are discrepancies between current recommendations and present implementation (e.g. the use of local nerve blocks to provide opioid-sparing analgesia or the use of abdominal drains). CONCLUSION: The implementation of the FT concept in Austria and Germany is still in need of improvement. Particularly regarding the use of abdominal drains and postoperative analgesia, there is a tendency to stick to traditional structures. To overcome the issues with FT implementation, the development of an evidence-based S3 guideline for perioperative care, followed by the founding of a surgical working group to conduct a structured education and certification process, may lead to significant improvements in perioperative patient care.

Quality assurance and quality control in surgical oncology.

Even though surgery has remained a key component within multi-disciplinary cancer care, the expectations have changed. Instead of serving as a modality to free a patient of a mass at all means and at the risk of high morbidity, modern cancer surgery is expected to provide adequate tumor clearance with lowest invasiveness. This review summarizes the evidence on quality assurance in surgical oncology and gives a comprehensive overview of quality improvement tools.

Endoscopic papillectomy or pancreaticoduodenectomy for ampullary lesions: a single center retrospective cohort study.

BACKGROUND: This study aimed to compare post-operative morbidity, mortality, and completeness of resection following endoscopic vs. radical surgical resection for ampullary lesions. METHODS: A retrospective analysis of the prospectively collected data from a surgical database for patients with ampullary lesions at our institution was performed. All consecutive patients undergoing endoscopic papillectomy (EP) or pancreaticoduodenectomy (PD) for ampullary lesions between 2007 and 2021 were eligible for this analysis. RESULTS: A total of 85 patients were included of whom 42 underwent EP whereas 43 received a PD. The resected lesion was a tubulovillous adenoma in 26 patients (61.9%) in the EP cohort, and 37 patients (86.0%) in the PD cohort had adenocarcinomas. The completeness of resection was equal in both cohorts. Significantly more patients of the PD cohort had to undergo reinterventions. After a mean follow up of 36 months (EP) vs. 16 months (PD), the rate of tumor recurrence did not differ between both groups. CONCLUSION: Equivalently high completeness of resection rates and correspondingly low recurrence rates can be achieved after EP and PD. Our results regarding residual tumor and recurrence rates show that even large tumors can be resected endoscopically with high primary success and completeness of resection rates.

Interventions to reduce the incidence of surgical site infection in colorectal resections: systematic review with multicomponent network meta-analysis (INTRISSI): study protocol.

OBJECTIVE: To assess the relative contribution of intravenous antibiotic prophylaxis, mechanical bowel preparation, oral antibiotic prophylaxis, and combinations thereof towards the reduction of surgical site infection (SSI) incidence in elective colorectal resections. METHODS AND ANALYSIS: A systematic search of randomised controlled trials comparing interventions to reduce SSI incidence will be conducted with predefined search terms in the following databases: MEDLINE, LILACS, Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR). Additionally, several online databases will be searched for ongoing trials, and conference proceedings and reference lists of retrieved articles will be hand searched. The title-abstract screening will be partly performed by means of a semiautomated supervised machine learning approach, which will be trained on a subset of the identified titles and abstracts identified through traditional screening methods.The primary analysis will be a multicomponent network meta-analysis, as we expect to identify studies that investigate combinations of interventions (eg, mechanical bowel preparation combined with oral antibiotics) as well as studies that focus on individual components (mechanical bowel preparation or oral antibiotics). By means of a multicomponent network meta-analysis, we aim at estimating the effects of the separate components along the effects of the observed combinations. To account for between-trial heterogeneity, a random-effect approach will be combined with inverse variance weighting for estimation of the treatment effects. Associated 95% CIs will be calculated as well as the ranking for each component in the network using P scores. Results will be visualised by network graphics and forest plots of the overall pairwise effect estimates. Comparison-adjusted funnel plots will be used to assess publication bias. ETHICS AND DISSEMINATION: Ethical approval by the Ethical Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (ID of approval: 2021-148). Results shall be disseminated directly to decision-makers (eg, surgeons, gastroenterologists, wound care specialists) by means of publication in peer-reviewed journals, presentation at conferences and through the media (eg, radio, TV, etc). PROSPERO REGISTRATION NUMBER: CRD42021267322.

Less is more-the best test for anastomotic leaks in rectal cancer patients prior to ileostomy reversal.

PURPOSE: No clear consensus exists on how to routinely assess the integrity of the colorectal anastomosis prior to ileostomy reversal. The objective of this study was to evaluate the accuracy of contrast enema, endoscopic procedures, and digital rectal examination in rectal cancer patients in this setting. METHODS: A systematic literature search was performed. Studies assessing at least one index test for which a 2 × 2 table was calculable were included. Hierarchical summary receiver operating characteristic curves were calculated and used for test comparison. Paired data were used where parameters could not be calculated. Methodological quality was assessed with the QUADAS-2 tool. RESULTS: Two prospective and 11 retrospective studies comprising 1903 patients were eligible for inclusion. Paired data analysis showed equal or better results for sensitivity and specificity of both endoscopic procedures and digital rectal examination compared to contrast enema. Subgroup analysis of contrast enema according to methodological quality revealed that studies with higher methodological quality reported poorer sensitivity for equal specificity and vice versa. No case was described where a contrast enema revealed an anastomotic leak that was overseen in digital rectal examination or endoscopic procedures. CONCLUSIONS: Endoscopy and digital rectal examination appear to be the best diagnostic tests to assess the integrity of the colorectal anastomosis prior to ileostomy reversal. Accuracy measures of contrast enema are overestimated by studies with lower methodological quality. Synopsis of existing evidence and risk-benefit considerations justifies omission of contrast enema in favor of endoscopic and clinical assessment. TRIAL REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019107771.

Colon ischemia in patients with severe COVID-19: a single-center retrospective cohort study of 20 patients.

PURPOSE: Thromboembolic complications due to COVID-19 are common in patients requiring critical care and are associated with high morbidity and mortality rates. The aim of this study was to evaluate clinical manifestations and postoperative outcomes after colectomy for COVID-19-associated colonic ischemia in the first versus the second wave of the pandemic. METHODS: A retrospective cohort study of patients with severe COVID-19 at our institution between 1 March 2020 and 31 January 2021 was performed. All patients with severe COVID-19, requiring critical care and surgical treatment of colonic ischemia, were included. The main outcomes were surgical complications and mortality rate. RESULTS: A total of 190 patients were included of whom 20 (10.5%) patients underwent surgery for colon ischemia. Preoperatively, D-dimer was elevated, especially in the first wave (median 15.24 (interquartile range 6.00-32.00) vs. 2.09 (1.42-4.28) mg/L, p = 0.025). Twelve (60%) patients underwent a (sub)total colectomy, 7 (35%) a right hemicolectomy, and one patient (5%) an ileocecal resection. Grade 3b complications occurred in one of 5 patients (20%) in the first and in 9 of 15 patients (60%) in the second wave. The overall in-hospital mortality was similar in both waves (40% vs. 47%), with death occurring after a median stay of 21 days. CONCLUSION: In this cohort study of patients with severe COVID-19 and colonic ischemia, clinical presentation and laboratory findings varied. However, the majority of patients required (sub)total colectomy. Despite a lower threshold to surgery in the second wave, mortality remained high.

Development of a Single-Step Antibody-Drug Conjugate Purification Process with Membrane Chromatography.

Membrane chromatography is routinely used to remove host cell proteins, viral particles, and aggregates during antibody downstream processing. The application of membrane chromatography to the field of antibody-drug conjugates (ADCs) has been applied in a limited capacity and in only specialized scenarios. Here, we utilized the characteristics of the membrane adsorbers, Sartobind® S and Phenyl, for aggregate and payload clearance while polishing the ADC in a single chromatographic run. The Sartobind® S membrane was used in the removal of excess payload, while the Sartobind® Phenyl was used to polish the ADC by clearance of unwanted drug-to-antibody ratio (DAR) species and aggregates. The Sartobind® S membrane reproducibly achieved log-fold clearance of free payload with a 10 membrane-volume wash. Application of the Sartobind® Phenyl decreased aggregates and higher DAR species while increasing DAR homogeneity. The Sartobind® S and Phenyl membranes were placed in tandem to simplify the process in a single chromatographic run. With the optimized binding, washing, and elution conditions, the tandem membrane approach was performed in a shorter timescale with minimum solvent consumption and high yield. The application of the tandem membrane chromatography system presents a novel and efficient purification scheme that can be realized during ADC manufacturing.

[Initial experiences with the implementation of the enhanced recovery after surgery (ERAS®) protocol]. / Erste Erfahrungen in der Umsetzung eines ERAS®("enhanced recovery after surgery")-Konzepts.

BACKGROUND: To further improve treatment quality and patient orientation, a multiprofessional enhanced recovery after surgery (ERAS®) transformation program was initiated in our clinic in January 2020. The ERAS® treatment pathway for colorectal surgery was established in October 2020. OBJECTIVE: The aim of the study was to show that the perioperative treatment quality can be increased by implementing a certified ERAS® program in the setting of a fast-track pathway that has been established since 2008. MATERIAL AND METHODS: The first ERAS® patients from October/November 2020 (ERAS®) were compared with those of a representative consecutive control cohort (pre-ERAS®) who had undergone interventions from August to December 2019. Patient care and data collection of the ERAS® patients were ensured by an ERAS® nurse in daily visits. For the comparison cohorts, the electronic patient files were analyzed and historical colon pathway data from our clinic from 2008 were used. RESULTS AND CONCLUSION: A total of 10 ERAS® and 50 pre-ERAS® patients were included. After the ERAS® transformation, an increase in overall compliance with ERAS® guideline recommendations from 45% (pre-ERAS®) to 75% (ERAS®) was achieved. The number of days to tolerance of solid food decreased from 2 days (pre-ERAS®) to 1 day (ERAS®). The general postoperative complication rate was comparable (22% pre-ERAS® vs. 20% ERAS®). Most noticeable was the reduction of the median hospital stay of 9 days in the historical cohort to 3 days after ERAS® implementation. We attribute the necessary high ERAS® pathway compliance of 75% to a successful combination of process standards and multiprofessional ERAS® teams.

Molecular characterization of ulcerative colitis-associated colorectal carcinomas.

Patients with ulcerative colitis (UC) are at increased risk for developing colorectal cancer (CRC). In contrast to sporadic colorectal tumorigenesis, TP53 mutations occur early in the progression from inflamed colonic epithelium to dysplasia to CRC, and are sometimes readily detectable in inflamed, (yet) non-dysplastic mucosa. Here, we analyzed formalin-fixed paraffin-embedded tissue samples from 19 patients with long-standing UC (median 18 years, range 3 to 34) who had developed CRC as a consequence of chronic inflammation of the large bowel. We performed microsatellite instability testing, copy number analysis by array-based comparative genomic hybridization, mutation analysis by targeted next generation sequencing (48-gene panel) and TP53 immunostaining. The results were compared to The Cancer Genome Atlas (TCGA) data on sporadic CRC. All UC-CRC lesions in our cohort were microsatellite stable. Overall, genomic imbalances of UC-CRCs showed patterns of chromosomal aneuploidies characteristic for sporadic CRC with the exception of gains of chromosome arm 5p (12 of 23 UC-CRC, 52%), which are rare in sporadic CRCs from TCGA (21 of 144, 15%; FDR adjusted P = 0.006). UC-CRCs showed a predilection for TP53 alterations, which was the most frequently mutated gene in our cohort (20 of 23, 87%). Interestingly, spatially separated tumor lesions from individual patients tended to harbor distinct TP53 mutations. Similar to CRCs arising in a background of Crohn's colitis, the genetic landscape of UC-CRCs was characterized by TP53 mutations and chromosomal aneuploidies including gains of chromosome arm 5p. Both alterations harbor the potential for early detection in precursor lesions, thus complementing morphologic diagnosis.

Postoperative Morbidity and Failure to Rescue in Surgery for Gastric Cancer: A Single Center Retrospective Cohort Study of 1107 Patients from 1972 to 2014.

BACKGROUND: The aim of this study was to evaluate postoperative morbidity, mortality, and failure to rescue following complications after radical resection for gastric cancer. METHODS: A retrospective analysis of the surgical database of patients with gastroesophageal malignancies at our institution was performed. All consecutive patients undergoing R0 gastrectomy for pT1-4 M0 gastric adenocarcinoma between October 1972 and February 2014 were eligible for this analysis. Patients were divided into two groups according to the date of surgery: an early cohort operated on from 1972-1992 and a late cohort operated on from 1993-2014. Both groups were compared regarding patient characteristics and surgical outcomes. RESULTS: A total of 1107 patients were included. Postoperative mortality was more than twice as high in patients operated on from 1972-1992 compared to patients operated on from 1993-2014 (6.8% vs. 3.2%, p = 0.017). Between both groups, no significant difference in failure to rescue after major surgical complications was observed (20.8% vs. 20.5%, p = 1.000). Failure to rescue after other surgical and non-surgical complications was 37.8% in the early cohort compared to 3.2% in the late cohort (p < 0.001). Non-surgical complications accounted for 71.2% of lethal complications between 1972 and 1992, but only for 18.2% of lethal complications between 1993 and 2014 (p = 0.002). CONCLUSION: In the course of four decades, postoperative mortality after radical resection for gastric cancer has more than halved. In this cohort, the reason for this decrease was reduced mortality due to non-surgical complications. Major surgical morbidity after gastrectomy remains challenging.

Surgery for Gastric Remnant Cancer Results in Similar Overall Survival Rates Compared with Primary Gastric Cancer: A Propensity Score-Matched Analysis.

BACKGROUND: The purpose of this study was to investigate clinical features, prognostic factors, and overall survival (OS) in surgical patients with gastric remnant cancer (GRC). METHODS: A retrospective analysis of patients with gastrectomy for pT1-4 gastric cancer between October 1972 and February 2014 at our institution was performed. Clinical characteristics were compared between patients with GRC and those with primary gastric cancer (PGC). Multivariable Cox regression analysis was performed to determine the prognostic factors for OS in patients with GRC. A propensity score-matched cohort was used to investigate OS between the GRC and PGC groups. RESULTS: Of a baseline cohort of 1440 patients, 95 patients with GRC were identified. Patients with GRC underwent more multivisceral resections (p < 0.001) than patients with PGC despite lower tumor stages (p = 0.018); however, R0 resection rates were not significantly different (p = 0.211). The postoperative overall (p = 0.032) and major surgical (p = 0.021) complication rates and the 30-day (p = 0.003) and in-hospital (p = 0.008) mortality rates were higher in patients with GRC. In multivariable analysis, the only prognostic factors for worse OS in GRC were higher tumor stage (p < 0.001) and the occurrence of postoperative complications (p < 0.001). OS between propensity score-matched GRC and PGC groups was not significantly different (p = 0.772). CONCLUSIONS: GRC required more invasive surgery than PGC; however, the feasibility of R0 resection was similar. The prognostic factors of GRC were similar to those of PGC, and OS was not significantly different between both groups. Patients with GRC benefit from extensive surgery when performed with low morbidity and mortality.

Role of Albumin as a Nutritional and Prognostic Marker in Elective Intestinal Surgery.

Background: The aim of this study was to investigate albumin, nutritional status, and inflammation in the perioperative course of patients undergoing elective intestinal surgery. Methods: A retrospective analysis of patients with preoperative measurements of nutritional parameters who underwent intestinal surgery between April 2017 and August 2018 at our institution was performed. Preoperatively, the correlation of albumin levels with markers for inflammation and nutritional status was investigated. Postoperatively, albumin levels were assessed with regard to high-grade morbidity and inflammation. Results: A total of 105 patients were included. Preoperatively, albumin levels were correlated with both markers for nutritional status and inflammation, with phase angle (PA) (p=0.004) and C-reactive protein (CRP) (p < 0.001) as independent factors predicting the albumin levels in multivariable analysis. Postoperatively, the reduction in serum albumin (∆-albumin) on postoperative day (POD) 1/2 (p=0.025) and POD 4/5 (p=0.003) was significantly associated with Clavien-Dindo complications ≥grade III. A cut-off value of 27.3% for ∆-albumin on POD 1/2 predicted postoperative high-grade morbidity (sensitivity 75% and specificity 69%). The product of ∆-albumin and CRP on POD 4/5 identified patients with major complications more reliably than ∆-albumin or CRP alone (sensitivity 91% and specificity 72%). Conclusion: Preoperatively, albumin was a marker for nutritional status even if an inflammatory component was present. Postoperatively, ∆-albumin on POD 1/2 predicted high-grade morbidity. A new marker to identify patients with major complications on POD 4/5 is presented.

Role of Postoperative Complications in Overall Survival after Radical Resection for Gastric Cancer: A Retrospective Single-Center Analysis of 1107 Patients.

Background: The aim of this study was to investigate the impact of postoperative complications on overall survival (OS) after radical resection for gastric cancer. Methods: A retrospective analysis of our institutional database for surgical patients with gastroesophageal malignancies was performed. All consecutive patients who underwent R0 resection for M0 gastric cancer between October 1972 and February 2014 were included. The impact of postoperative complications on OS was evaluated in the entire cohort and in a subgroup after exclusion of 30 day and in-hospital mortality. Results: A total of 1107 patients were included. In the entire cohort, both overall complications (p < 0.001) and major surgical complications (p = 0.003) were significant risk factors for decreased OS in univariable analysis. In multivariable analysis, overall complications were an independent risk factor for decreased OS (p < 0.001). After exclusion of patients with complication-related 30 day and in-hospital mortality, neither major surgical (p = 0.832) nor overall complications (p = 0.198) were significantly associated with decreased OS. Conclusion: In this study, postoperative complications influenced OS due to complication-related early postoperative deaths. In patients successfully rescued from early postoperative complications, neither overall complications nor major surgical complications were risk factors for decreased survival.

Clinical, oncological, and functional outcomes of Da Vinci (Xi)-assisted versus conventional laparoscopic resection for rectal cancer: a prospective, controlled cohort study of 51 consecutive cases.

PURPOSE: Despite the increasing use of telemanipulators in colorectal surgery, an additional benefit in terms of improved perioperative results is not proven. The aim of the study was to compare clinical, oncological, and functional results of Da Vinci (Xi)-assisted versus conventional laparoscopic (low) anterior resection for rectal cancer. METHODS: Monocenter, prospective, controlled cohort study with a 12-month follow-up of bladder and sexual function using the validated questionnaires International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index. RESULTS: Fifty-one patients were included (18, Da Vinci (Xi) assisted; 33, conventional laparoscopy). Conversion to an open approach was more common in the Da Vinci cohort (p = 0.012). In addition, surgery and resumption of a normal diet took longer in the robotic group (p = 0.005; p = 0.042). Surgical morbidity and oncological quality did not differ. There was no difference in most functional domains, except for worsened ability to orgasm (p = 0.047) and sexual satisfaction (p = 0.034) in women after conventional laparoscopy. Moreover, we found a higher rate of improved bladder function in the conventional laparoscopy group (p = 0.023) and less painful sexual intercourse among women in the robot-assisted group (p = 0.049). CONCLUSION: In contrast to the ROLARR trial, a higher conversion rate was found in the robotic cohort, which may in part be explained by a learning curve effect. Nevertheless, the Da Vinci-assisted approach showed favorable results regarding sexual function.