Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study.

BACKGROUND: Abdominal computed tomography (CT) is the standard imaging method for patients with suspected colorectal liver metastases (CRLM) in the diagnostic workup for surgery or thermal ablation. Diffusion-weighted and gadoxetic-acid-enhanced magnetic resonance imaging (MRI) of the liver is increasingly used to improve the detection rate and characterization of liver lesions. MRI is superior in detection and characterization of CRLM as compared to CT. However, it is unknown how MRI actually impacts patient management. The primary aim of the CAMINO study is to evaluate whether MRI has sufficient clinical added value to be routinely added to CT in the staging of CRLM. The secondary objective is to identify subgroups who benefit the most from additional MRI. METHODS: In this international multicentre prospective incremental diagnostic accuracy study, 298 patients with primary or recurrent CRLM scheduled for curative liver resection or thermal ablation based on CT staging will be enrolled from 17 centres across the Netherlands, Belgium, Norway, and Italy. All study participants will undergo CT and diffusion-weighted and gadoxetic-acid enhanced MRI prior to local therapy. The local multidisciplinary team will provide two local therapy plans: first, based on CT-staging and second, based on both CT and MRI. The primary outcome measure is the proportion of clinically significant CRLM (CS-CRLM) detected by MRI not visible on CT. CS-CRLM are defined as liver lesions leading to a change in local therapeutical management. If MRI detects new CRLM in segments which would have been resected in the original operative plan, these are not considered CS-CRLM. It is hypothesized that MRI will lead to the detection of CS-CRLM in ≥10% of patients which is considered the minimal clinically important difference. Furthermore, a prediction model will be developed using multivariable logistic regression modelling to evaluate the predictive value of patient, tumor and procedural variables on finding CS-CRLM on MRI. DISCUSSION: The CAMINO study will clarify the clinical added value of MRI to CT in patients with CRLM scheduled for local therapy. This study will provide the evidence required for the implementation of additional MRI in the routine work-up of patients with primary and recurrent CRLM for local therapy. TRIAL REGISTRATION: The CAMINO study was registered in the Netherlands National Trial Register under number NL8039 on September 20th 2019.

Comparing practice and outcome of laparoscopic liver resection between high-volume expert centres and nationwide low-to-medium volume centres.

BACKGROUND: Based on excellent outcomes from high-volume centres, laparoscopic liver resection is increasingly being adopted into nationwide practice which typically includes low-medium volume centres. It is unknown how the use and outcome of laparoscopic liver resection compare between high-volume centres and low-medium volume centres. This study aimed to compare use and outcome of laparoscopic liver resection in three leading European high-volume centres and nationwide practice in the Netherlands. METHOD: An international, retrospective multicentre cohort study including data from three European high-volume centres (Oslo, Southampton and Milan) and all 20 centres in the Netherlands performing laparoscopic liver resection (low-medium volume practice) from January 2011 to December 2016. A high-volume centre is defined as a centre performing >50 laparoscopic liver resections per year. Patients were retrospectively stratified into low, moderate- and high-risk Southampton difficulty score groups. RESULTS: A total of 2425 patients were included (1540 high-volume; 885 low-medium volume). The median annual proportion of laparoscopic liver resection was 42.9 per cent in high-volume centres and 7.2 per cent in low-medium volume centres. Patients in the high-volume centres had a lower conversion rate (7.4 versus 13.1 per cent; P < 0.001) with less intraoperative incidents (9.3 versus 14.6 per cent; P = 0.002) as compared to low-medium volume centres. Whereas postoperative morbidity and mortality rates were similar in the two groups, a lower reintervention rate (5.1 versus 7.2 per cent; P = 0.034) and a shorter postoperative hospital stay (3 versus 5 days; P < 0.001) were observed in the high-volume centres as compared to the low-medium volume centres. In each Southampton difficulty score group, the conversion rate was lower and hospital stay shorter in high-volume centres. The rate of intraoperative incidents did not differ in the low-risk group, whilst in the moderate-risk and high-risk groups this rate was lower in high-volume centres (absolute difference 6.7 and 14.2 per cent; all P < 0.004). CONCLUSION: High-volume expert centres had a sixfold higher use of laparoscopic liver resection, less conversions, and shorter hospital stay, as compared to a nationwide low-medium volume practice. Stratification into Southampton difficulty score risk groups identified some differences but largely outcomes appeared better for high-volume centres in each risk group.

[Weight gain after bariatric surgery]. / Gewichtstoename na bariatrische chirurgie.

Despite the frequent success of bariatric surgery, 20-30% of patients do not respond well. These patients may experience insufficient weight loss, defined as primary non-response, or may regain an excessive amount of weight after sufficient weight loss, defined as secondary non-response. The aetiology and subsequent treatment of these two types of non-response may differ. This is illustrated by three cases: a patient with primary non-response after gastric bypass (total weight loss 18%) treated conservatively; a patient with secondary non-response after gastric bypass (total weight loss 27%) treated conservatively and lost 7kg as a result of this therapy; a patient with secondary non-response after gastric bypass (total weight loss 27%) treated surgically though experienced malabsorptive complaints as result of distalisation. These cases can be used to demonstrate the challenges that are faced by professionals in the current treatment of post-bariatric surgery patients.

Banded Roux-en-Y gastric bypass in patients with super morbid obesity (BRandY-study): protocol of a cohort study with 10 year follow-up.

BACKGROUND: Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2). Non-response, either defined as insufficient weight loss or weight regain after initial successful weight loss, is a matter of serious concern in these patients. The primary banded Roux-en-Y gastric bypass has shown promising results regarding weight loss in the bariatric population. However, up to now, long-term comparative data about the banded and non-banded bypass in superobese patients is lacking. The aim of this study is to assess the added value of the banded Roux-en-Y gastric bypass in superobese patients on long-term weight loss outcomes. METHODS: This single center study will evaluate superobese patients who receive a non-banded Roux-en-Y gastric bypass (NB-RYGB) and a banded Roux-en-Y gastric bypass (B-RYGB). Data from the NB-RYGB group will be collected in retrospect, while data from the B-RYGB group will be collected prospectively. When performing a B-RYGB, a 7.0-8.0 cm silastic ring (MiniMizer®) will be placed proximal to the gastrojejunostomy. The main outcomes of this study are weight loss and non-response during a 10 year follow-up period. Secondary outcomes are reduction of obesity related comorbidities and medication, (ring-related) morbidity and mortality, complications, re-operations, patient satisfaction and health-related quality of life. A total of 142 patients will be included in this study. DISCUSSION: This study will help establish the clinical utility of the B-RYGB in superobese patients. TRIAL REGISTER: NL8093. Registered 15 October 2019 - Retrospectively registered on the Dutch Registry of Clinical trials, www.trialregister.nl.

Preoperative imaging for colorectal liver metastases: a nationwide population-based study.

BACKGROUND: In patients with colorectal liver metastases (CRLM) preoperative imaging may include contrast-enhanced (ce) MRI and [18 F]fluorodeoxyglucose (18 F-FDG) PET-CT. This study assessed trends and variation between hospitals and oncological networks in the use of preoperative imaging in the Netherlands. METHODS: Data for all patients who underwent liver resection for CRLM in the Netherlands between 2014 and 2018 were retrieved from a nationwide auditing database. Multivariable logistic regression analysis was used to assess use of ceMRI, 18 F-FDG PET-CT and combined ceMRI and 18 F-FDG PET-CT, and trends in preoperative imaging and hospital and oncological network variation. RESULTS: A total of 4510 patients were included, of whom 1562 had ceMRI, 872 had 18 F-FDG PET-CT, and 1293 had combined ceMRI and 18 F-FDG PET-CT. Use of ceMRI increased over time (from 9·6 to 26·2 per cent; P < 0·001), use of 18 F-FDG PET-CT decreased (from 28·6 to 6·0 per cent; P < 0·001), and use of both ceMRI and 18 F-FDG PET-CT 16·9 per cent) remained stable. Unadjusted variation in the use of ceMRI, 18 F-FDG PET-CT, and combined ceMRI and 18 F-FDG PET-CT ranged from 5·6 to 100 per cent between hospitals. After case-mix correction, hospital and oncological network variation was found for all imaging modalities. DISCUSSION: Significant variation exists concerning the use of preoperative imaging for CRLM between hospitals and oncological networks in the Netherlands. The use of MRI is increasing, whereas that of 18 F-FDG PET-CT is decreasing.

ANTECEDENTES: En pacientes con metástasis hepáticas colorrectales (colorrectal liver metastases, CRLM), los estudios de imagen preoperatorios pueden incluir resonancia magnética con contraste (ce)MRI y 18 F-FDG-PET-CT. Este estudio evaluó las tendencias y la variación entre los hospitales y las redes oncológicas en el uso de estudios de imagen preoperatorios en los Países Bajos. MÉTODOS: Todos los pacientes que se sometieron a una resección hepática por CRLM en los Países Bajos entre 2014 y 2018 fueron seleccionados a partir de una base de datos a nivel nacional auditada. El análisis de regresión logística multivariable se utilizó para evaluar el uso de ceMRI, de 18 F-FDG-PET-CT y de ceMRI combinado con 18 F-FDG-PET-CT, así como para determinar las tendencias en los estudios de imagen preoperatorios y las variaciones hospitalarias y de la red oncológica. RESULTADOS: En total, se incluyeron 4.510 pacientes, de los cuales 1.562 se sometieron a ceMRI, 872 a 18 F-FDG-PET-CT y 1.293 a ceMRI combinado con 18 F-FDG-PET-CT. El uso de ceMRI aumentó con el tiempo del 9,6% al 26,2% (P < 0,001), el uso de 18 F-FDG-PET-CT disminuyó (25% a 6,0%, P < 0,001) y el uso de ceMRI y 18 F-FDG-PET- CT (17%) se mantuvo estable. La variación no ajustada entre hospitales en el uso de ceMRI, 18 F-FDG-PET-CT y la combinación de ceMRI y 18 F-FDG-PET-CT oscilaba del 5% al 10%. Después de la corrección por case-mix, la variación hospitalaria y de la red oncológica persistía en todas las pruebas de imagen. CONCLUSIÓN: En los Países Bajos existe una variación significativa entre hospitales y redes oncológicas respecto al uso de pruebas de imagen preoperatorias para el CRLM. El uso de MRI está aumentando, mientras que el uso de 18 F-FDG-PET-CT está disminuyendo.

Volume-outcome relationship of liver surgery: a nationwide analysis.

BACKGROUND: Evidence for an association between hospital volume and outcomes for liver surgery is abundant. The current Dutch guideline requires a minimum volume of 20 annual procedures per centre. The aim of this study was to investigate the association between hospital volume and postoperative outcomes using data from the nationwide Dutch Hepato Biliary Audit. METHODS: This was a nationwide study in the Netherlands. All liver resections reported in the Dutch Hepato Biliary Audit between 2014 and 2017 were included. Annual centre volume was calculated and classified in categories of 20 procedures per year. Main outcomes were major morbidity (Clavien-Dindo grade IIIA or higher) and 30-day or in-hospital mortality. RESULTS: A total of 5590 liver resections were done across 34 centres with a median annual centre volume of 35 (i.q.r. 20-69) procedures. Overall major morbidity and mortality rates were 11·2 and 2·0 per cent respectively. The mortality rate was 1·9 per cent after resection for colorectal liver metastases (CRLMs), 1·2 per cent for non-CRLMs, 0·4 per cent for benign tumours, 4·9 per cent for hepatocellular carcinoma and 10·3 per cent for biliary tumours. Higher-volume centres performed more major liver resections, and more resections for hepatocellular carcinoma and biliary cancer. There was no association between hospital volume and either major morbidity or mortality in multivariable analysis, after adjustment for known risk factors for adverse events. CONCLUSION: Hospital volume and postoperative outcomes were not associated.

ANTECEDENTES: La asociación entre el volumen hospitalario y los resultados de la cirugía hepática no está clara. Según la recomendación actual de las guías holandesas se requiere un volumen mínimo de 20 procedimientos anuales por centro. El objetivo de este estudio fue analizar la asociación entre el volumen hospitalario con los resultados postoperatorios en la auditoría hepatobiliar obligatoria holandesa a nivel nacional. MÉTODOS: Se realizó un estudio a nivel nacional en los Países Bajos. Se incluyeron todas las resecciones hepáticas registradas en la auditoría hepatobiliar holandesa entre 2014 y 2017. El volumen anual del centro se calculó y se clasificó en categorías de 20 procedimientos por año. Los objetivos principales fueron la morbilidad de mayor grado (Clavien-Dindo grado IIIA o superior) y la mortalidad hospitalaria o la mortalidad a los 30 días. RESULTADOS: Se realizaron un total de 5.590 resecciones en 34 centros con una mediana (rango intercuartílico) de volumen anual de 35 procedimientos (20-69). La tasa global de morbilidad mayor fue del 11% y la mortalidad del 2%. La mortalidad fue de 1,9% después de la resección por metástasis hepáticas colorrectales (colorectal liver metastases, CRLM), 1,2% para no CRLM, 0,4% para tumores benignos, 4,9% para carcinoma hepatocelular, y 10,3% para tumores biliares. Los centros de mayor volumen realizaron más resecciones hepáticas mayores y más resecciones por carcinoma hepatocelular y cáncer biliar. En el análisis multivariable después de ajustar por factores de riesgo conocidos de eventos adversos, no se observó ninguna asociación entre el volumen hospitalario y la morbilidad o mortalidad mayor. CONCLUSIÓN: No hubo asociación entre el volumen hospitalario y los resultados postoperatorios de la cirugía hepática en los Países Bajos.

Histological examination of the gallbladder following routine cholecystectomy? A selective analysis is justified.

BACKGROUND: It was hitherto common practice to analyse each removed gallbladder for the presence of gall bladder cancer (GBC) although this approach may be questioned. The aim of this study was to determine whether a policy of selective histopathological analysis (Sel-HPA) is oncologically safe and cost effective. METHODS: This retrospective study was conducted in a single Dutch teaching hospital. Immediately following cholecystectomy, the surgeon decided on the basis of inspection and palpation whether histological examination was indicated. The Dutch Comprehensive Cancer Organisation (IKNL) registry was used to identify the number of GBC during this time period. RESULTS: Of 2271 patients who underwent a cholecystectomy in our institution between January 2012 and December 2017, 1083 (47.7%) were deemed indicated for histopathological analysis. Sixteen pathological gallbladders (1.5%) were identified in that period (intestinal metaplasia, n = 3; low grade dysplasia n = 7; carcinoma n = 6). During follow-up, no patient was found to have GBC recurrence in the population whose gallbladder was not sent for pathology (52.3%, n = 1188, median 49 months of follow up). The percentage of gallbladders that were analysed decreased over the six years of observation from 83% to 38%. Our policy of Sel-HP saved over €65 000. CONCLUSIONS: A policy of selective histopathology after cholecystectomy is oncologically safe and reduces costs.

Selective Histological Examination After Cholecystectomy: An Analysis of Current Daily Practice in The Netherlands.

BACKGROUND: The 2016 Dutch national guidelines on handling of a removed gallbladder for cholelithiasis proposes a selective histopathologic policy (Sel-HP) rather than routine policy (Rout-HP). The aim of this study was to determine the current implementation of the present guideline and the daily practice of Sel-HP. METHODS: Surgeons who were engaged in gallbladder surgery in the Netherlands and were involved in local hospitals' gallbladder protocols completed a questionnaire study regarding gallbladder policy, between December 2017 and May 2018. Data were analyzed using standard statistics. RESULTS: A 100% response rate was obtained (n = 74). Approximately 64% of all gallbladders (n = 22,500) were examined microscopically. Sixty-nine (93.2%) hospitals confirmed they were aware of the new guidelines, and 56 (75.7%) knew the guideline was adjusted in favor of Sel-HP. Half of the hospitals (n = 35, 47.3%) had adopted a Sel-HP, and 39 (52.7%) a Rout-HP. Of the 39 hospitals who had a Rout-HP, 36 were open to a transition to a Sel-HP although some expressed the need for more evidence on safety or novel guidelines. CONCLUSIONS: The current implementation of the 2016 Dutch guideline advising a selective microscopic analysis of removed gallbladders for gallstone disease is suboptimal. Evidence demonstrating safety and cost-effectiveness of an on demand histopathological examination will aid in the implementation process.

Insight in Information Provision Prior to Obtaining Surgical Informed Consent-by Audiotaping Outpatient Consultations.

BACKGROUND: Literature suggests that patient-informing process prior to obtaining surgical informed consent (SIC) does not function well. This study aimed to provide insight into the current practice of SIC in the Netherlands. METHODS: This is a prospective, observational, and multicenter study, conducted in one academic and two non-academic teaching hospitals in the Netherlands. Audio recordings were made during outpatient consultations with patients presenting with Dupuytren Disease. The recorded informing process was scored according to a checklist. Written documentation of the SIC process in the patient's chart was compared to these scored checklists. Time spent on SIC during the consultations was also recorded. RESULTS: A total of 41 outpatient consultations were included in the study. Consultations were conducted by 25 plastic surgeons and their residents. Average time spent on SIC was 55.6% of the total consultation time. Considerable variation was observed concerning the amount and type of information given and discussed. In 59% of the consultations, discrepancies were observed between written documentation of consultations and audio recordings. Information on treatment risks, the postoperative period, and the operating surgeon was addressed the least. CONCLUSION: Despite a relatively large part of the consultation time being spent on SIC, patients received scarce information concerning treatment risks, postoperative period, and who their operating surgeon would be. Discrepancies were observed between the written documentation of SIC and information recorded on the audio recordings. This occurred predominantly in one hospital that used a pre-made list of 'discussed information' in its digital patient chart.

A decade of litigation regarding surgical informed consent in the Netherlands.

OBJECTIVE: An inadequate surgical informed consent process (SIC) may result in a medical malpractice claim or medical disciplinary board (MDB) complaint. Aim of this study was to analyse characteristics of a decade of malpractice claims and MDB decisions regarding SIC in the Netherlands. METHODS: A retrospective analysis of malpractice claims and MDB decisions concerning SIC disputes in four major surgical specialties was conducted based on company data from the largest medical malpractice insurance company and two public available online MDB databases. RESULTS: A total of 11376 malpractice claims and 661 MDB complaints were filed between 2004-2013 and 676(6%) of these claims and 69(10%) of these complaints involved an alleged deficient SIC process. A random sample of 245(37%) claims and all MDB decisions were analysed. Reasons for filing a claim or complaint were insufficient counselling or recording of SIC elements. In 20% of lawsuits and 25% of claims the case resulted in favour of the complainant. CONCLUSION: A substantial portion of malpractice claims and MDB decisions is related to a deficient SIC process. PRACTICE IMPLICATIONS: Focusing on crucial SIC elements for patients may improve satisfaction and expectations and result in a lower risk for malpractice claims and MDB complaints.

Outcome of Surgical Inspection of the Gallbladder in Relation to Final Pathology.

INTRODUCTION: Routine histopathologic gallbladder examination after cholecystectomy has been a point of discussion. The aim of this study was to evaluate the macroscopic examination by the surgeon in relation to the final histology. METHODS: A prospective study was conducted to investigate the practice of macroscopic gallbladder examination by a surgeon compared to routine histopathology by a pathologist. All consecutive cholecystectomies were included between November 2009 and February 2011. RESULTS: A total of 319 consecutive cholecystectomies were performed. Of all macroscopic examinations, the surgeon identified 62 gallbladders with macroscopic abnormalities, ranging from polyps to wall thickening or ulcers. In 55 (17.2%) cases, the surgeon judged that further examination of the specimen by the pathologist could possibly lead to additional and relevant findings. There was a strong agreement between the surgeon and the pathologist concerning the macroscopic examination (κappa = 0.822). The surgeon and the pathologist had disagreement on the macroscopic examination of 18 gallbladders, without clinical consequences for the patient. DISCUSSION: The present prospective study shows that the surgeon should be able to select those gallbladders needing a microscopic gallbladder examination. Potentially, about 80% of this kind of routine histology can be reduced.

Mesh Versus Patch Repair for Epigastric and Umbilical Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled Trial.

DESIGN: This trial is a randomized controlled, patient-blinded, multicentre, superiority trial. METHODS: All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED® Ventral Patch) (PVP). The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complication rates. RESULTS: A total of 352 patients were randomized in this trial; 348 patients received the intervention (n = 177 PVP vs. n = 171 mesh). No peri-operative complications occurred. PVP placement was significantly faster compared to mesh placement (30 min, SD 11 vs. 35 min, SD 11) and was scored as an easier procedure. At 1-month follow-up, 76 patients suffered any kind of complication. There was no significant difference in the proportion of complications (24.9% for PVP and 18.7% for mesh, p = 0.195). A significant difference was seen in re-operation rate within 1 month, significantly less early re-operations in the mesh group (0.0 vs. 2.8%, p = 0.027). After 1-year follow-up, no significant differences are seen in recurrence rates (n = 13, 7.8% PVP vs. n = 5, 3.3% mesh, p = 0.08). CONCLUSIONS: Both mesh and PVP had a comparable amount of reported complications. There was a significantly higher incidence of early re-operations due to early complications in the PVP group. No differences were seen in infection rates and the need for antibiotic treatment. No significant difference was seen in the recurrence rates. REGISTRATION: This trial was registered in the Dutch Trail Registry (NTR) NTR2514NL33995.060.10. [12].

A modified Chevrel technique for ventral hernia repair: long-term results of a single centre cohort.

PURPOSE: To evaluate the short- and long-term results after a modified Chevrel technique for midline incisional hernia repair, regarding surgical technique, hospital stay, wound complications, recurrence rate, and postoperative quality of life. These results will be compared to the literature derived reference values regarding the original and modified Chevrel techniques. METHODS: In this large retrospective, single surgeon, single centre cohort all modified Chevrel hernia repairs between 2000 and 2012 were identified. Results were obtained by reviewing patients' medical charts. Postoperative quality of life was measured using the Carolina Comfort Scale. A multi-database literature search was conducted to compare the results of our series to the literature based reference values. RESULTS: One hundred and fifty-five patients (84 male, 71 female) were included. Eighty patients (52%) had a large incisional hernia (width ≥ 10 cm) according the definition of the European Hernia Society. Fourteen patients (9%) underwent a concomitant procedure. Median length-of-stay was 5 days. Within 30 days postoperative 36 patients (23.2%) had 39 postoperative complications of which 30 were mild (CDC I-II), and nine severe (CDC III-IV). Thirty-one surgical site occurrences were observed in thirty patients (19.4%) of which the majority were seroma (16 patients 10.3%). There was no hernia-related mortality during follow-up. Recurrence rate was 1.8% after a median follow-up of 52 months (12-128 months). Postoperative quality of life was rated excellent. CONCLUSIONS: The modified Chevrel technique for midline ventral hernias results in a moderate complication rate, low recurrence rate and high rated postoperative quality of life.