Economic burden of pelvic sepsis after anastomotic leakage following rectal cancer surgery: A retrospective cost-of-illness analysis.

AIM: Anastomotic leakage following rectal cancer surgery remains a challenging complication, with a nonhealing rate of approximately 50% at 1 year. Pelvic sepsis may require tertiary treatment that encompasses additional admissions, extensive surgery and other types of interventions. The aim of this study is to analyse the financial burden of pelvic sepsis in a tertiary hospital. METHOD: From 2010 until 2020, all patients referred to a tertiary centre for pelvic sepsis after low anterior resection for rectal cancer were prospectively registered and retrospectively reviewed. The cost analysis adhered to Dutch National Healthcare Institute guidelines and covered hospital-imposed medical costs from salvage surgery to the last registered intervention, adjusted for inflation and priced in euros. RESULTS: This analysis included 126 patients, with an average total cost per patient of €31 131. Salvage surgery accounted for €21 326, with an additional €9805 for reinterventions and readmissions. Salvage surgery comprised nonrestorative surgery in 48% and restorative salvage surgery in the remaining cases. Length of hospital stay averaged 9.6 days on the general ward and 0.8 days in the intensive care unit. Common reinterventions included endoscopic vacuum sponge changes (n = 153), stoma closures (n = 59) and radiological abscess drainages (n = 51). Total costs did not differ significantly between nonrestorative surgery and restorative surgery (mean = €31 950 vs. €30 362, respectively; p = 0.893). CONCLUSION: Treating pelvic sepsis after rectal cancer resection in a tertiary hospital carries a substantial economic burden, averaging €31 131 per patient, and this work helps to quantify the potential economic impact of innovative care to reduce anastomotic leakage.

Short-term outcomes after primary total mesorectal excision (TME) versus local excision followed by completion TME for early rectal cancer: population-based propensity-matched study.

BACKGROUND: Colorectal cancer screening programmes have led to a shift towards early-stage colorectal cancer, which, in selected cases, can be treated using local excision. However, local excision followed by completion total mesorectal excision (two-stage approach) may be associated with less favourable outcomes than primary total mesorectal excision (one-stage approach). The aim of this population study was to determine the distribution of treatment strategies for early rectal cancer in the Netherlands and to compare the short-term outcomes of primary total mesorectal excision with those of local excision followed by completion total mesorectal excision. METHODS: Short-term data for patients with cT1-2 N0xM0 rectal cancer who underwent local excision only, primary total mesorectal excision, or local excision followed by completion total mesorectal excision between 2012 and 2020 in the Netherlands were collected from the Dutch Colorectal Audit. Patients were categorized according to treatment groups and logistic regressions were performed after multiple imputation and propensity score matching. The primary outcome was the end-ostomy rate. RESULTS: From 2015 to 2020, the proportion for the two-stage approach increased from 22.3% to 43.9%. After matching, 1062 patients were included. The end-ostomy rate was 16.8% for the primary total mesorectal excision group versus 29.6% for the local excision followed by completion total mesorectal excision group (P < 0.001). The primary total mesorectal excision group had a higher re-intervention rate than the local excision followed by completion total mesorectal excision group (16.7% versus 11.8%; P = 0.048). No differences were observed with regard to complications, conversion, diverting ostomies, radical resections, readmissions, and death. CONCLUSION: This study shows that, over time, cT1-2 rectal cancer has increasingly been treated using the two-stage approach. However, local excision followed by completion total mesorectal excision seems to be associated with an elevated end-ostomy rate. It is important that clinicians and patients are aware of this risk during shared decision-making.

Diagnostic Performance of MRI and FDG PET/CT for Preoperative Locoregional Staging of Colon Cancer: Systematic Review and Meta-Analysis.

Background: CT is the standard-of-care test for colon cancer (CC) preoperative locoregional staging, but has limited diagnostic performance. More accurate preoperative staging would guide selection among expanding patient-tailored treatment options. Objective: To evaluate the diagnostic performance of MRI for T and N staging and of FDG PET/CT for N staging in CC locoregional staging through systematic review. Evidence Acquisition: PubMed, Embase, and Cochrane Library were searched through December 31, 2023 for studies reporting diagnostic performance of MRI or FDG PET/CT for primary (nonrectal) CC before resection without neoadjuvant therapy using histopathology as reference. Study quality was assessed using the QUADAS-2 tool. Publication bias was assessed with Deeks' funnel plot. Primary outcomes were estimated pooled predictive values, stratified by T and N categories for MRI and N categories for PET/CT. Secondary outcomes were pooled sensitivity and specificity. Evidence Synthesis: The systematic review included 11 MRI studies (686 patients) and five PET/CT studies (408 patients). Thirteen studies had at least one risk of bias or concern of applicability. Deeks' funnel plot asymmetry indicated possible publication bias in MRI studies for differentiation of T3cd-4 from T1-3ab disease and N- from N+ disease. For MRI, for discriminating T1-2 from T3-4 disease, PPV was 64.8% (95% CI [52.9-75.5%]), and NPV was 88.9% (95% CI [82.7-93.7%]); for discriminating T1-3ab from T3cd-4 disease, PPV was 83.4% (95% CI [75.0-90.3%]), and NPV was 74.6% (95% CI [58.2-86.7%]); for discriminating T1-3 from T4 disease, PPV was 94.0% (95% CI [89.4-97.3%]), and NPV was 39.9% (95% CI [24.9-56.6%]); for discriminating N- from N+ disease, PPV was 74.9% (95% CI [69.3-80.0%]), and NPV was 53.9% (95% CI [45.3-62.0%]). For PET/CT, for discriminating N- from N+ disease, PPV was 76.4% (95% CI [67.9-85.1%]), and NPV was 68.2% (95% CI [56.8-78.6%]). Across outcomes, MRI and PET/CT exhibited pooled sensitivity of 55.1-81.4% and pooled specificity of 70.3-88.1%. Conclusion: MRI had strongest predictive performance for T1-2 and T4 disease. MRI and PET/CT had otherwise limited predictive values, sensitivity, and specificity for evaluated outcomes related T and N staging. Clinical Impact: MRI and FDG PET/CT had overall limited utility for preoperative locoregional staging in colon cancer.

Prophylactic Mesh-related Reoperations and Mesh-related Problems During Subsequent Relaparotomies: Long-term Results From the PRIMA Trial.

OBJECTIVE: This study aimed to evaluate all mesh-related problems during reoperations after mesh-reinforcement 15 years after the start of the PRIMA trial. SUMMARY BACKGROUND DATA Prophylactic mesh reinforcement during closure of a midline laparotomy has proven to reduce the incidence of incisional hernia, especially in high-risk patients, but long-term mesh-related morbidity is largely unknown. METHODS: Patients receiving a prophylactic onlay or retro-rectus mesh in the PRIMA trial between 2009 and 2012 were included on an as-treated basis from participating centers that made reoperation notes available. Main outcomes were the incidences of complications requiring mesh explantation, mesh-related ileus, and mesh-related problems during laparotomy for other diagnoses. METHODS: Out of 373 patients randomized to prophylactic mesh reinforcement, 242 were included: 127 with onlay and 115 patients with retrorectus mesh. Median follow-up is 27 months (IQR 12-78). Thirty-four patients underwent reoperation for any reason during entire follow-up, 22 after onlay (17.3%) and 12 after retrorectus mesh (10.4%). Reoperation rate for complications that required mesh explantation was 4/127 (3.1%) after onlay and 0/115 (0%) after retrorectus mesh. Mesh-related ileus occurred in none of the onlay group, and 3/115 (2.6%) in the retrorectus group. During subsequent laparotomies for other primary diagnoses, adhesions to the mesh were noted in 3/10 patients in the onlay group and 1/5 patients in the retro-rectus group. Overall, the mesh was removed in 10/127 (7.9%) in the onlay group and 7/115 (6.1%) patients in the retro-rectus group. CONCLUSIONS: In high-risk patients receiving a prophylactic mesh during midline laparotomy closure, low incidences of mesh-related complications requiring reoperation and mesh-related problems during unrelated subsequent laparotomies were found, for both the onlay and retrorectus techniques.

Dutch national guidelines for locally recurrent rectal cancer.

Due to improvements in treatment for primary rectal cancer, the incidence of LRRC has decreased. However, 6-12% of patients will still develop a local recurrence. Treatment of patients with LRRC can be challenging, because of complex and heterogeneous disease presentation and scarce - often low-grade - data steering clinical decisions. Previous consensus guidelines have provided some direction regarding diagnosis and treatment, but no comprehensive guidelines encompassing all aspects of the clinical management of patients with LRRC are available to date. The treatment of LRRC requires a multidisciplinary approach and overarching expertise in all domains. This broad expertise is often limited to specific expert centres, with dedicated multidisciplinary teams treating LRRC. A comprehensive, narrative literature review was performed and used to develop the Dutch National Guideline for management of LRRC, in an attempt to guide decision making for clinicians, regarding the complete clinical pathway from diagnosis to surgery.

Long-term restoration of bowel continuity after rectal cancer resection and the influence of surgical technique: A nationwide cross-sectional study.

AIM: Literature on nationwide long-term permanent stoma rates after rectal cancer resection in the minimally invasive era is scarce. The aim of this population-based study was to provide more insight into the permanent stoma rate with interhospital variability (IHV) depending on surgical technique, with pelvic sepsis, unplanned reinterventions and readmissions as secondary outcomes. METHOD: Patients who underwent open or minimally invasive resection of rectal cancer (lower border below the sigmoid take-off) in 67 Dutch centres in 2016 were included in this cross-sectional cohort study. RESULTS: Among 2530 patients, 1470 underwent a restorative resection (58%), 356 a Hartmann's procedure (14%, IHV 0%-42%) and 704 an abdominoperineal resection (28%, IHV 3%-60%). Median follow-up was 51 months. The overall permanent stoma rate at last follow-up was 50% (IHV 13%-79%) and the unintentional permanent stoma rate, permanent stoma after a restorative procedure or an unplanned Hartmann's procedure, was 11% (IHV 0%-29%). A total of 2165 patients (86%) underwent a minimally invasive resection: 1760 conventional (81%), 170 transanal (8%) and 235 robot-assisted (11%). An anastomosis was created in 59%, 80% and 66%, with corresponding unintentional permanent stoma rates of 12%, 24% and 14% (p = 0.001), respectively. When corrected for age, American Society of Anesthesiologists classification, cTNM, distance to the anorectal junction and neoadjuvant (chemo)radiotherapy, the minimally invasive technique was not associated with an unintended permanent stoma (p = 0.071) after a restorative procedure. CONCLUSION: A remarkable IHV in the permanent stoma rate after rectal cancer resection was found. No beneficial influence of transanal or robot-assisted laparoscopy on the unintentional permanent stoma rate was found, although this might be caused by the surgical learning curve. A reduction in IHV and improving preoperative counselling for decision-making for restorative procedures are required.

Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA).

INTRODUCTION: Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement. METHODS AND ANALYSIS: We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors. ETHICS AND DISSEMINATION: No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online. PROSPERO REGISTRATION NUMBER: CRD42022347881.

Prognostic significance of MRI-detected extramural venous invasion according to grade and response to neo-adjuvant treatment in locally advanced rectal cancer A national cohort study after radiologic training and reassessment.

BACKGROUND: Detection of grade 3-4 extra mural venous invasion (mrEMVI) on magnetic resonance imaging (MRI) is associated with an increased distant metastases (DM)-rate. This study aimed to determine the impact of different grades of mrEMVI and their disappearance after neoadjuvant therapy. METHODS: A Dutch national retrospective cross-sectional study was conducted, including patients who underwent resection for rectal cancer in 2016 from 60/69 hospitals performing rectal surgery. Patients with a cT3-4 tumour ≤8 cm from the anorectal junction were selected and their MRI-scans were reassessed by trained abdominal radiologists. Positive mrEMVI grades (3 and 4) were analyzed in regard to 4-year local recurrence (LR), DM, disease-free survival (DFS) and overall survival (OS). RESULTS: The 1213 included patients had a median follow-up of 48 months (IQR 30-54). Positive mrEMVI was present in 324 patients (27%); 161 had grade 3 and 163 had grade 4. A higher mrEMVI stage (grade 4 vs grade 3 vs no mrEMVI) increased LR-risk (21% vs 18% vs 7%, <0.001) and DM-risk (49% vs 30% vs 21%, p < 0.001) and decreased DFS (42% vs 55% vs 69%, p < 0.001) and OS (62% vs 76% vs 81%, p < 0.001), which remained independently associated in multivariable analysis. When mrEMVI had disappeared on restaging MRI, DM-rate was comparable to initial absence of mrEMVI (both 26%), whereas LR-rate remained high (22% vs 9%, p = 0.006). CONCLUSION: The negative oncological impact of mrEMVI on recurrence and survival rates was dependent on grading. Disappearance of mrEMVI on restaging MRI decreased the risk of DM, but not of LR.

Impact of the new rectal cancer definition on multimodality treatment and interhospital variability: Results from a nationwide cross-sectional study.

AIM: This study aimed to determine the consequences of the new definition of rectal cancer for decision-making in multidisciplinary team meetings (MDT). The new definition of rectal cancer, the lower border of the tumour is located below the sigmoid take-off (STO), was implemented in the Dutch guideline in 2019 after an international Delphi consensus meeting to reduce interhospital variations. METHOD: All patients with rectal cancer according to the local MDT, who underwent resection in 2016 in the Netherlands were eligible for this nationwide collaborative cross-sectional study. MRI-images were rereviewed, and the tumours were classified as above or on/below the STO. RESULTS: This study registered 3107 of the eligible 3178 patients (98%), of which 2784 patients had an evaluable MRI. In 314 patients, the tumour was located above the STO (11%), with interhospital variation between 0% and 36%. Based on TN-stage, 175 reclassified patients with colon cancer (6%) would have received different treatment (e.g., omitting neoadjuvant radiotherapy, candidate for adjuvant chemotherapy). Tumour location above the STO was independently associated with lower risk of 4-year locoregional recurrence (HR 0.529; p = 0.030) and higher 4-year overall survival (HR 0.732; p = 0.037) compared to location under the STO. CONCLUSION: By using the STO, 11% of the prior MDT-based diagnosis of rectal cancer were redefined as sigmoid cancer, with potential implications for multimodality treatment and prognostic value. Given the substantial interhospital variation in proportion of redefined cancers, the use of the STO will contribute to standardisation and comparability of outcomes in both daily practice and trial settings.

Value of Size and Malignant Features of Lateral Lymph Nodes in Risk Stratification at Lateral Local Recurrence of Rectal Cancer: A National Cohort Study.

BACKGROUND: Patients with rectal cancer who have enlarged lateral lymph nodes (LLNs) have an increased risk of lateral local recurrence (LLR). However, little is known about prognostic implications of malignant features (internal heterogeneity, irregular margins, loss of fatty hilum, and round shape) on MRI and number of enlarged LLNs, in addition to LLN size. METHODS: Of the 3,057 patients with rectal cancer included in this national, retrospective, cross-sectional cohort study, 284 with a cT3-4 tumor located ≤8 cm from the anorectal junction who received neoadjuvant treatment and who had visible LLNs on MRI were selected. Imaging was reassessed by trained radiologists. LLNs were categorized based on size. Influence of malignant features and the number of LLNs on LLR was investigated. RESULTS: Of 284 patients with at least 1 visible LLN, 122 (43%) had an enlarged node (≥7.0 mm) and 157 (55%) had malignant features. Of the 122 patients with enlarged nodes, 25 had multiple (≥2). In patients with a single enlarged node (n=97), a single malignant feature was associated with a 4-year LLR rate of 0% and multiple malignant features was associated with a rate of 17% (P=.060). In the group with multiple malignant features, their disappearance on restaging was associated with an LLR rate of 13% compared with an LLR rate of 20% for persistent malignant features (P=.532). The presence of intermediate-size LLNs (5.0-6.9 mm) with at least 1 malignant feature was associated with a 4-year LLR rate of 8%; the 4-year LLR rate was 13% when the malignant features persisted on restaging MRI (P=.409). Patients with multiple enlarged LLNs had a 4-year LLR rate of 28% compared with 11% for those with a single enlarged LLN (P=.059). CONCLUSIONS: The presence of multiple enlarged LLNs (≥7.0 mm), as well as multiple malignant features in an enlarged node contribute to the risk of developing an LLR. These radiologic features can be used for clinical decision-making regarding the potential benefit of LLN dissection.

Management of acute and chronic pelvic sepsis after total mesorectal excision for rectal cancer-a 10-year experience of a national referral centre.

AIM: Uncontrolled pelvic sepsis following rectal cancer surgery may lead to dramatic consequences with significant impact on patients' quality of life. The aim of this retrospective observational study is to evaluate management of pelvic sepsis after total mesorectal excision for rectal cancer at a national referral centre. METHOD: Referred patients with acute or chronic pelvic sepsis after sphincter preserving rectal cancer resection, with the year of referral between 2010 and 2014 (A) or between 2015 and 2020 (B), were included. The main outcome was control of pelvic sepsis at the end of follow-up, with healed anastomosis with restored faecal stream (RFS) as co-primary outcome. RESULTS: In total 136 patients were included: 49 in group A and 87 in group B. After a median follow-up of 82 months (interquartile range 35-100) in group A and 42 months (interquartile range 22-60) in group B, control of pelvic sepsis was achieved in all patients who received endoscopic vacuum assisted surgical closure (7/7 and 2/2), in 91% (19/21) and 89% (31/35) of patients who received redo anastomosis (P = 1.000) and in 100% (18/18) and 95% (41/43) of patients who received intersphincteric resection (P = 1.000), respectively. Restorative procedures resulted in a healed anastomosis with RFS in 61% (17/28) of patients in group A and 68% (25/37) of patients in group B (P = 0.567). CONCLUSION: High rates of success can be achieved with surgical salvage of pelvic sepsis in a dedicated tertiary referral centre, without significant differences over time. In well selected and motivated patients a healed anastomosis with RFS can be achieved in the majority.

Identifying a common data dictionary across colorectal cancer outcome registries: A mapping exercise to identify opportunities for data dictionary harmonisation.

IMPORTANCE: The development of colorectal cancer outcome registries internationally has been organic, with differing datasets, data definitions and infrastructure across registries which has limited data pooling and international comparison. Currently there is no comprehensive data dictionary identified as a standard. This study is part of an international collaboration that aims to identify areas of data capture and usage which may be optimised to improve understanding of colorectal cancer outcomes. OBJECTIVE: This study aimed to compare and identify commonalities and areas of difference across major colorectal cancer registries. We sought to establish datasets comprising of mutually collected common fields, and a combined comprehensive dataset of all collected fields across major registries to aid in establishing a future colorectal cancer registry database standard. DESIGN AND METHODS: This mixed qualitative and quantitative study compared data dictionaries from three major colorectal cancer outcome registries: Bowel Cancer Outcomes Registry (BCOR) (Australia and New Zealand), National Bowel Cancer Audit (NBOCA) (United Kingdom) and Dutch ColoRectal Audit (DCRA) (Netherlands). Registries were compared and analysed thematically, and a common dataset and combined comprehensive dataset were developed. These generated datasets were compared to data dictionaries from Sweden (SCRCR), Denmark (DCCG), Argentina (BNCCR-A) and the USA (NAACCR and ACS NSQIP). Fields were assessed against prominent quality indicator metrics from the literature and current case-use. RESULTS: We developed a combined comprehensive dataset of 225 fields under seven domains: demographic, pre-operative, operative, post-operative, pathology, neoadjuvant therapy, adjuvant therapy, and follow up/recurrence. A common dataset was developed comprising 38 overlapping fields, showing a low degree of mutually collected data, especially in preoperative, post operative and adjuvant therapy domains. The BNCCR-A, SCRCR and DCCG databases all contained a high percentage of common dataset fields. Fields were poorly comparable when viewed form current quality indicator metrics. CONCLUSION: This study mapped data dictionaries of prominent colorectal cancer registries and highlighted areas of commonality and difference The developed common field dataset provides a foundation for registries to benchmark themselves and work towards harmonisation of data dictionaries. This has the potential to enable meaningful large-scale international outcomes research.

Variation in hospital performances after colorectal cancer surgery: A case-mix adjusted Dutch population based study.

BACKGROUND: This study aimed to investigate hospital variability in postoperative mortality and anastomotic leakage (AL) after colorectal cancer surgery, as well as the association with hospital volume and teaching status. MATERIALS AND METHODS: This nationwide population based study derived data from CRC patients who underwent a surgical resection with primary anastomosis from the Netherlands Cancer Registry between 2015 and 2020. Primary outcomes were 90-day mortality and AL for colon cancer (CC) patients, and AL for rectal cancer (RC) patients. Logistic regression modelling was used to evaluate the association between case-mix factors and hospital volume. Variability in outcomes between hospitals was analysed with Poisson regression. RESULTS: This study included 44,101 CRC patients, comprising 35,164 CC patients, and 8937 RC patients. In the CC cohort, the unadjusted rates of AL ranged from 2.6 % to 14.4 %, and the unadjusted 90-day mortality rates ranged from 0.0 % to 6.7 %. In the RC cohort, the unadjusted rates of AL ranged from 0.0 % to 28.6 %. After case-mix adjustment, two hospitals performed significantly worse than expected regarding 90-day mortality in the CC cohort, and in both CC and RC cohorts, significant outliers were observed concerning AL. Amongst CC patients, low case volume (OR 1.26 95%CI 1.08-1.46) was significantly associated with AL. CONCLUSION: Statistically significant variations in hospital performance were observed among Dutch hospitals after CRC surgery, but this effect could not be entirely attributed to hospitals' teaching status. Nevertheless, concentrating care has the potential to improve outcomes by enhancing individual surgical performance and optimizing care pathways.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial.

Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

Evolution of surgical approach to rectal cancer resection: A multinational registry assessment.

PURPOSE: Surgical approach to rectal cancer has evolved in recent decades, with introduction of minimally invasive surgery (MIS) techniques and local excision. Since implementation might differ internationally, this study is aimed at evaluating trends in surgical approach to rectal cancer across different countries over the last 10 years and to gain insight into patient, tumour and treatment characteristics. METHODS: Pseudo-anonymised data of patients undergoing resection for rectal cancer between 2010 and 2019 were extracted from clinical audits in the Netherlands (NL), Sweden (SE), England-Wales (EW) and Australia-New Zealand (AZ). RESULTS: Ninety-nine thousand five hundred ninety-seven patients were included (38,413 open, 55,155 MIS and 5416 local excision). An overall increase in MIS was observed from 29.9% in 2010 to 72.1% in 2019, with decreasing conversion rates (17.5-9.0%). The MIS proportion was highly variable between countries in the period 2010-2014 (54.4% NL, 45.3% EW, 39.8% AZ, 14.1% SE, P < 0.001), but variation reduced over time (2015-2019 78.8% NL, 66.3% EW, 64.3% AZ, 53.2% SE, P < 0.001). The proportion of local excision for the two periods was highly variable between countries: 4.7% and 11.8% in NL, 3.9% and 7.4% in EW, 4.7% and 4.6% in AZ, 6.0% and 2.9% in SE. CONCLUSIONS: Application and speed of implementation of MIS were highly variable between countries, but each registry demonstrated a significant increase over time. Local excision revealed inconsistent trends over time.

Timing of restoration of bowel continuity after decompressing stoma, in left-sided obstructive colon cancer: a nationwide retrospective cohort.

BACKGROUND: With the increasing use of decompressing stoma as a bridge to surgery for left-sided obstructive colon cancer (LSOCC), the timing of restoration of bowel continuity (ROBC) is a subject of debate. There is a lack of data on immediate ROBC during elective resection as an alternative for a 3-stage procedure. This study analysed if immediate ROBC during tumour resection is safe and of any benefit for patients who underwent decompressing stoma for LSOCC. METHODS: In a Dutch nationwide collaborative research project, 3153 patients who underwent resection for LSOCC in 75 hospitals (2009-2016) were identified. Extensive data on disease and procedural characteristics, and outcomes was collected by local collaborators. For this analysis, 332 patients who underwent decompressing stoma followed by curative resection were selected. Immediate ROBC during tumour resection was compared to two no immediate ROBC groups, (1) tumour resection with primary anastomosis (PA) with leaving the decompressing stoma in situ, and (2) tumour resection without PA. RESULTS: Immediate ROBC was performed in 113 patients (34.0%) and no immediate ROBC in 219 patients [168 with PA (50.6%) and 51 patients without PA (15.4%)]. No differences at baseline between the groups were found for age, ASA score, cT, and cM. Major surgical complications (8.8% immediate ROBC vs. 4.8% PA with decompressing stoma and 7.8% no PA; P =0.37) and mortality (2.7% vs. 2.4% and 0%, respectively; P =0.52) were similar. Immediate ROBC resulted in a shorter time with a stoma (mean 41 vs. 240 and 314 days, respectively; P <0.001), and fewer permanent stomas (7% vs. 21% and 80%, respectively; P <0.001) as compared to PA with a decompressing stoma or no PA. CONCLUSION: After a decompressing stoma for LSOCC, immediate ROBC during elective resection appears safe, reduces the total time with a stoma and the risk of a permanent stoma.

Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Whether adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) might prevent peritoneal metastases after curative surgery for high-risk colon cancer is an ongoing debate. This study aimed to determine 5-year oncologic outcomes of the randomized multicenter COLOPEC trial, which included patients with clinical or pathologic T4N0-2M0 or perforated colon cancer and randomly assigned (1:1) to either adjuvant systemic chemotherapy and HIPEC (n = 100) or adjuvant systemic chemotherapy alone (n = 102). HIPEC was performed using a one-time administration of oxaliplatin (460 mg/m2, 30 minutes, 42°C, concurrent fluorouracil/leucovorin intravenously), either simultaneously (9%) or within 5-8 weeks (91%) after primary tumor resection. Outcomes were analyzed according to the intention-to-treat principle. Long-term data were available of all 202 patients included in the COLOPEC trial, with a median follow-up of 59 months (IQR, 54.5-64.5). No significant difference was found in 5-year overall survival rate between patients assigned to adjuvant HIPEC followed by systemic chemotherapy or only adjuvant systemic chemotherapy (69.6% v 70.9%, log-rank; P = .692). Five-year peritoneal metastases rates were 63.9% and 63.2% (P = .907) and 5-year disease-free survival was 55.7% and 52.3% (log-rank; P = .875), respectively. No differences in quality-of-life outcomes were found. Our findings implicate that adjuvant HIPEC should still be performed in trial setting only.

Prognostic Implications of Lateral Lymph Nodes in Rectal Cancer: A Population-Based Cross-sectional Study With Standardized Radiological Evaluation After Dedicated Training.

BACKGROUND: There is an ongoing discussion regarding the prognostic implications of the presence, short-axis diameter, and location of lateral lymph nodes. OBJECTIVE: To analyze lateral lymph node characteristics, the role of downsizing on restaging MRI, and associated local recurrence rates for patients with cT3-4 rectal cancer after MRI re-review and training. DESIGN: Retrospective population-based cross-sectional study. SETTINGS: This collaborative project was led by local investigators from surgery and radiology departments in 60 Dutch hospitals. PATIENTS: A total of 3057 patients underwent rectal cancer surgery in 2016: 1109 had a cT3-4 tumor located ≤8 cm from the anorectal junction, of whom 891 received neoadjuvant therapy. MAIN OUTCOME MEASURES: Local recurrence and (ipsi) lateral local recurrence rates. RESULTS: Re-review identified 314 patients (35%) with visible lateral lymph nodes. Of these, 30 patients had either only long-stretched obturator (n = 13) or external iliac (n = 17) nodes, and both did not lead to any lateral local recurrences. The presence of internal iliac/obturator lateral lymph nodes (n = 284) resulted in 4-year local recurrence and lateral local recurrence rates of 16.4% and 8.8%, respectively. Enlarged (≥7 mm) lateral lymph nodes (n = 122) resulted in higher 4-year local recurrence (20.8%, 13.1%, 0%; p <.001) and lateral local recurrence (14.7%, 4.4%, 0%; p < 0.001) rates compared to smaller and no lateral lymph nodes, respectively. Visible lateral lymph nodes (HR 1.8 [1.1-2.8]) and enlarged lateral lymph nodes (HR 1.9 [1.1-3.5]) were independently associated with local recurrence in multivariable analysis. Enlarged lateral lymph nodes with malignant features had higher 4-year lateral local recurrence rates of 17.0%. Downsizing had no impact on lateral local recurrence rates. Enlarged lateral lymph nodes were found to be associated with higher univariate 4-year distant metastasis rates (36.4% vs 24.4%; p = 0.021), but this was not significant in multivariable analyses (HR 1.3 [0.9-1.]) and did not worsen overall survival. LIMITATIONS: This study was limited by the retrospective design and total number of patients with lateral lymph nodes. CONCLUSIONS: The risk of lateral local recurrence due to (enlarged) lateral lymph nodes was confirmed, but without the prognostic impact of downsizing after neoadjuvant therapy. These results point toward the incorporation of primary lateral lymph node size into treatment planning. See Video Abstract. IMPLICACIONES PRONSTICAS DE LOS NDULOS LINFTICOS LATERALES EN EL CNCER DE RECTO UN ESTUDIO TRANSVERSAL DE BASE POBLACIONAL CON EVALUACIN RADIOLGICA ESTANDARIZADA DESPUS DE UN ENTRENAMIENTO ESPECFICO: ANTECEDENTES:Hay una discusión en curso acerca de las implicaciones pronósticas de la presencia, el diámetro del eje corto y la ubicación de los nódulos linfáticos laterales.OBJETIVO:Analizar las características de los nódulos linfáticos laterales, el rol de la reducción de tamaño en la IRM de reestratificación y las tasas de recurrencia local asociadas para pacientes con cáncer de recto cT3-4 después de una nueva revisión y entrenamiento de IRM.DISEÑO:Estudio transversal retrospectivo poblacional.CONFIGURACIÓN:Este proyecto colaborativo fue dirigido por investigadores locales de los departamentos de cirugía y radiología en 60 hospitales holandeses.PACIENTES:3057 pacientes fueron operados de cáncer de recto en 2016: 1109 tenían tumor cT3-4 ubicado a ≤8 cm de la unión anorrectal de los cuales 890 recibieron terapia neoadyuvante.INTERVENCIONES(S):Ninguna.PRINCIPALES MEDIDAS DE RESULTADO:recurrencia local y tasas de recurrencia local ipsilateral.RESULTADOS:Una nueva revisión identificó a 314 pacientes (35%) con nódulos linfáticos laterales visibles. 30 de estos pacientes tenían solo nódulos obturadores estirados (n = 13) o ilíacos externos (n = 17) y ambos no provocaron recurrencias locales laterales. La presencia de nódulos linfáticos laterales ilíacos internos/obturadores (n = 284) dio como resultado tasas de recurrencia local y recurrencia local lateral a los 4 años del 16.4% y el 8.8%, respectivamente. Los nódulos linfáticos laterales agrandados (≥7 mm) (n = 122) resultaron en una mayor recurrencia local a los 4 años (20.8%, 13.1%, 0%, p < 0.001) y recurrencia local lateral (14.7%, 4.4%, 0%, p < 0.001) en comparación con nódulos linfáticos más pequeños y sin nódulos linfáticos laterales, respectivamente. Los nódulos linfáticos laterales visibles (índice de riesgo 1,8 (1,1-2,8)) y los nódulos linfáticos laterales agrandados (índice de riesgo 1.9 (1.1-3.5)) se asociaron de forma independiente con la recurrencia local en el análisis multivariable. Los nódulos linfáticos laterales agrandados con características malignas tuvieron tasas de recurrencia local lateral a 4 años más altas del 17.0%. La reducción de tamaño no tuvo impacto en las tasas de recurrencia local lateral. Los nódulos linfáticos laterales agrandados se asociaron con tasas univariadas más altas de metástasis a distancia a los 4 años (36.4%, 24.4%, p = 0.021), pero no en el análisis multivariable (índice de riesgo 1.3 (0.9-1.8)), y no empeoró la supervivencia general.LIMITACIONES:Este estudio estuvo limitado por el diseño retrospectivo y el número total de pacientes con nódulos linfáticos laterales.CONCLUSIONES:Se confirmó el riesgo de recurrencia local lateral debido a los nódulos linfáticos laterales (agrandados), pero sin el impacto pronóstico de la reducción después de la terapia neoadyuvante. Estos resultados apuntan hacia la incorporación del tamaño del nódulo linfático lateral primario en la planificación del tratamiento. (Traducción-Dr. Aurian Garcia Gonzalez ).