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.

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".

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.

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.

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.

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.

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.

MTL, a composite measure for objectively profiling hospitals on surgical performance in colorectal cancer surgery.

PURPOSE: MTL is a composite outcome measure based on routine administrative data defined as (a) postoperative mortality and/or (b) postoperative transfer to another hospital and/or (c) length of hospital stay ≥ the prespecified time period. Aim of the present study was to investigate MTL for profiling hospitals on surgical performance in colorectal cancer surgery, using data from the national registers of the German Society of General and Visceral Surgery (DGAV) and to determine the time interval for length of stay with the highest accuracy regarding major complications (Clavien-Dindo grade ≥ 3). METHODS: All patients undergoing colorectal cancer resection between January 2010 and February 2017 were included. MTL rates were calculated and compared to well-established single outcome measures using multivariate regression analysis. For each outcome measure, postoperative complications were tested regarding their predictability. RESULTS: Data from 14,978 patients were analyzed. Length of stay was significantly prolonged if postoperative complications occurred (p < 0.0001). Thirty-day mortality and the indication for a transfer to another hospital mainly resulted from cardiopulmonary complications. MTL occurs significantly more often than any of the single-outcome parameters. The time interval of 22 days demonstrated the highest accuracy regarding severe complications (Clavien-Dindo grade ≥ 3). CONCLUSIONS: MTL reflects the complete spectrum of postoperative complications. Compared to individual surgical outcome parameters, MTL may have a better discriminatory power and is therefore suitable to mirror surgical quality. Because of its high accuracy regarding surgical major morbidity, 22 days is the best cut-off for length of stay within the German healthcare system.

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.

Risk factors for early postoperative complications in patients with Crohn's disease after colorectal surgery other than ileocecal resection or right hemicolectomy.

PURPOSE: To evaluate risk factors for early postoperative complications in patients with Crohn's disease (CD) after extensive colorectal resection excluding mere ileocecal resection or right hemicolectomy at a university center. METHODS: A retrospective analysis of the prospectively maintained database for surgical patients with CD at our institution was performed. All consecutive patients operated between December 2009 and December 2017 were included. RESULTS: In total, 126 patients were eligible for this study. Most common types of operations performed were subtotal colectomy or proctocolectomy (37.3%) and resections of the rectum (34.1%) or the sigmoid colon (14.3%). Major postoperative complications occurred in 29 patients (23.0%). The rate of local septic complications (anastomotic leak, postoperative abscess) was 11.1%. In univariate analysis, low preoperative albumin, elevated preoperative C-reactive protein (CRP), and emergency surgery were factors associated with major postoperative complications. When multivariable analysis was performed, low preoperative albumin was the only independent risk factor for the occurrence of major postoperative complications (p = 0.0033; OR 0.899). The cut-off value for albumin was 32.6 g/L. CONCLUSIONS: In this large cohort of consecutive patients undergoing surgery of the colorectum in CD, the rate of major postoperative complications was considerably higher compared to our recently published data from patients with ileocecal resection or right hemicolectomy. Preoperative albumin is the only independent risk factor for the occurrence of major postoperative complications. Preoperative albumin levels > 32.6 g/L significantly reduce the risk for postoperative complications.

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation.

BACKGROUND: A parastomal hernia is defined as an incisional hernia related to a stoma, and belongs to the most common stoma-related complications. Many factors, which are considered to influence the incidence of parastomal herniation, have been investigated. However, it remains unclear whether the enterostomy should be placed through, or lateral to the rectus abdominis muscle, in order to prevent parastomal herniation and other important stoma complications. OBJECTIVES: To assess if there is a difference regarding the incidence of parastomal herniation and other stoma complications, such as ileus and stenosis, in lateral pararectal versus transrectal stoma placement in people undergoing elective or emergency abdominal wall enterostomy. SEARCH METHODS: For this update, we searched for all types of published and unpublished randomized and non-randomized studies in four medical databases: CENTRAL, PubMed, LILACS, Science Ciation Index, and two trials registers: ICTRP Search Portal and ClinicalTrials.gov to 9 November 2018. We applied no language restrictions. SELECTION CRITERIA: Randomized and non-randomized studies comparing lateral pararectal versus transrectal stoma placement with regard to parastomal herniation and other stoma-related complications. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. We conducted data analyses according to the recommendations of Cochrane and the Cochrane Colorectal Cancer Group (CCCG). We rated quality of evidence according to the GRADE approach. MAIN RESULTS: Randomized controlled trials (RCT)Only one RCT met the inclusion criteria. The participants underwent enterostomy placement in the frame of an operation for: rectal cancer (37/60), ulcerative colitis (14/60), familial adenomatous polyposis (7/60), and other (2/60).The results between the lateral pararectal and the transrectal approach groups were inconclusive for the incidence of parastomal herniation (risk ratio (RR) 1.34, 95% confidence interval (CI) 0.40 to 4.48; low-quality evidence); development of ileus or stenosis (RR 2.0, 95% CI 0.19 to 20.9; low-quality evidence); or skin irritation (RR 0.67, 95% CI 0.21 to 2.13; moderate-quality evidence). The results were also inconclusive for the subgroup analysis in which we compared the effect of ileostomy versus colostomy on parastomal herniation. The study did not measured other stoma-related morbidities, or stoma-related mortality, but did measure quality of life, which was not one of our outcomes of interest.Non-randomized studies (NRS)Ten retrospective cohort studies, with a total of 864 participants, met the inclusion criteria. The indications for enterostomy placement and the baseline characteristics of the participants (age, co-morbidities, disease-severity) varied between studies. All included studies reported results for the primary outcome (parastomal herniation) and one study also reported data on one of the secondary outcomes (stomal prolapse).The effects of different surgical approaches on parastomal herniation (RR 1.22, 95% CI 0.84 to 1.75; 10 studies, 864 participants; very low-quality evidence) and the occurrence of stomal prolapse (RR 1.23, 95% CI 0.39 to 3.85; 1 study, 145 participants; very low-quality evidence) are uncertain.None of the included studies measured other stoma-related morbidity or stoma-related mortality. AUTHORS' CONCLUSIONS: The present systematic review of randomized and non-randomized studies found inconsistent results between the two compared interventions regarding their potential to prevent parastomal herniation.In conclusion, there is still a lack of high-quality evidence to support the ideal surgical technique of stoma formation. The available moderate-, low-, and very low-quality evidence, does not support or refute the superiority of one of the studied stoma formation techniques over the other.

Risk factors for early postoperative complications and length of hospital stay in ileocecal resection and right hemicolectomy for Crohn's disease: a single-center experience.

PURPOSE: To determine risk factors for early postoperative complications and longer hospital stay after ileocecal resection and right hemicolectomy in a single-center cohort of patients with Crohn's disease (CD). METHODS: A retrospective analysis of the prospectively maintained surgical database for patients with CD at our institution was performed. All consecutive patients operated on between January 2010 and December 2016 were included. RESULTS: A total of 305 patients were included. Median length of hospital stay was 7 days (interquartile range, IQR 6-10). Major postoperative complications were observed in 9.5% of patients (n = 29). Anastomotic leak was observed in five patients (1.8% of all patients with anastomosis). The rate of local septic complications was 4.3% (n = 13, anastomotic leak, postoperative abscess, and/or postoperative fistula). In multivariable analysis, independent risk factors for major postoperative complications were bowel perforation (odds ratio (OR) = 12.796, 95% CI = 1.144-143.178); elevated preoperative leucocyte levels (OR = 1.115, 95% CI = 1.013-1.228); and low levels of preoperative albumin (OR = 0.885, 95% CI = 0.827-0.948). The cutoff value for albumin was 32.5 g/L (sensitivity 75.9%, specificity 62.6%). CONCLUSIONS: In this large cohort of patients surgically treated for CD in a tertiary referral center, 9.5% of the patients developed major postoperative complications. Preoperative albumin levels > 32.5 g/L significantly reduce the risk for postoperative complications and shorten the length of hospital stay. In a multidisciplinary concept with adequate preoperative management, surgery can be performed with a low rate of major complications and a very low rate of anastomotic leakage.

New kid on the block: perineal stapled prolapse resection (PSP) is it worthwhile in the long-term?

PURPOSE: Perineal stapled prolapse resection (PSP) has been described as a new surgical treatment for external rectal prolapse in 2008. Short-term and midterm results acknowledged PSP as a safe, fast and simple procedure for high-risk patients. This study aims to assess long-term results after PSP. METHODS: All patients who underwent PSP from 2007 to 2015 were analyzed retrospectively. Data was gathered from medical records and operative reports and by interviews with the general practitioner or the patient. RESULTS: Indication for PSP was provided in 64 cases. One procedure had to be changed to an Altemeier's and another to a laparoscopic rectopexy. The median age was 79.9 years (range 25.9-97.5). Spinal anaesthesia was used in 19 patients. The median operation time was 32.5 min (range 25-51.2). There was no mortality. One patient had to be reoperated. All other complications were minor. The median hospital stay was 6.0 days (range 2-23). Median follow-up of patients alive was 6.0 years (range 0.2-8.4). The 5-year recurrence-free survival rate for primary prolapse was 70.1 % compared to 34.3 % for recurrent prolapses (p = 0.048). Further positive prognostic factors were specimen length over 8 cm and lack of preoperative obstructed defecation syndrome. Faecal incontinence was remedied in 18, and new onset was recorded in 6 patients (significant incontinence rate reduction (p = 0.025)). CONCLUSION: Due to low morbidity and the possibility of spinal anaesthesia, PSP is suitable for frail patients. The recurrence rate for primary prolapse is similar to alternative perineal procedures like Delorme's and Altemeier's, but inferior to the laparoscopic techniques.

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.

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.

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.

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation.

BACKGROUND: A parastomal hernia is defined as an incisional hernia related to a stoma and belongs to the most common stoma-related complications. Many factors concerning the operative technique which are considered to influence the incidence of parastomal herniation have been investigated. However, it remains unclear whether the enterostomy should be placed through or lateral to the rectus abdominis muscle in order to prevent parastomal herniation and other important stoma complications for people undergoing abdominal wall enterostomy. OBJECTIVES: To assess if there is a difference regarding the incidence of parastomal herniation and other stomal complications, such as ileus and stenosis, in lateral pararectal versus transrectal stoma placement in people undergoing elective or emergency abdominal wall enterostomy. SEARCH METHODS: In October and November 2012 we searched for all types of published and unpublished randomized and non-randomized studies with no restriction on language, date or country (search dates in brackets). We searched the bibliographic databases The Cochrane Library (4 October 2012), MEDLINE (1 October 2012), EMBASE (10 October 2012), LILACS (29 November 2012), and Science Citation Index Expanded (4 October 2012). We also searched the reference lists of all relevant studies and the trial registers ClinicalTrials.gov (9 October 2012), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal (10 October 2012), as well as three additional trial registers not included in the ICTRP (27 November 2012). SELECTION CRITERIA: Randomized and non-randomized studies comparing lateral pararectal versus transrectal stoma placement with regard to parastomal herniation and other stoma-related complications. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. Data analyses were conducted according to the recommendations of The Cochrane Collaboration and the Cochrane Colorectal Cancer Group (CCCG). Quality of evidence was rated according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Nine retrospective cohort studies with a total of 761 participants met the inclusion criteria. All included studies reported results for the primary outcome (parastomal herniation), and one study also reported data on one of the secondary outcomes (stomal prolapse). None of the included studies compared the two interventions with regard to other secondary outcomes.There was neither a significant difference in terms of the risk for parastomal herniation (risk ratio (RR) 1.29; 95% confidence interval (CI) 0.79 to 2.1) nor with regard to the occurrence of stomal prolapse (RR 1.23; 95% CI 0.39 to 3.85). An I² value of 65% indicated substantial statistical heterogeneity in the meta-analysis. AUTHORS' CONCLUSIONS: The poor quality of the included evidence does not allow a robust conclusion regarding the objectives of the review. This review highlights a clear uncertainty as to the relative merits of either approach. There is a need for randomized trials to evaluate the effectiveness of the lateral pararectal versus the transrectal approach in preventing parastomal herniation and other stoma-related morbidity in people requiring enterostomy placement.