The Effect of (Chemo)Radiotherapy on Enlarged Lateral Lymph Nodes in Patients With Locally Advanced Rectal Cancer.

BACKGROUND: Standard of care for most patients with locally advanced rectal cancer in The Netherlands consists of neoadjuvant chemoradiotherapy (nCRT) followed by resection. Enlarged lateral lymph nodes (LLNs), especially in the iliac compartment, appears to be associated with an increased risk of local recurrence. Little is known about the risk of local recurrence after nCRT. MATERIALS AND METHODS: This study included patients with locally advanced rectal cancer and enlarged LLNs on pretreatment MRI-scan located in the internal iliac, obturator, external iliac, or common iliac compartment. Patients were treated with nCRT and response to therapy was evaluated with MRI-scan. The primary endpoint was local lateral recurrence after nCRT. Secondary endpoints included overall survival and postoperative complications. RESULTS: Out of 260 patients treated for rectal cancer, a total of 46 patients with enlarged LLNs (18% of all patients) were included between 2012 and 2019 in 2 Dutch hospitals. No patients had lateral lymph node recurrence (LLNR) after nCRT. Only 1 patient had local recurrence of rectal cancer after radical resection during a median follow up of 3 years. Disseminated disease was seen in 12 patients and 9 patients died during follow-up, which result in an overall survival rate of 80.4%. Postoperative complications were seen in 41% of patients. There was no 90-days postoperative mortality. CONCLUSION: Enlarged LLNs are rare after nCRT and no LLNR was found after nCRT in our study population. This could suggest that nCRT only with or without an extra radiotherapeutic boost on enlarged LLNs already reduces the risk of LLNR.

Interprofessional collaboration skills and motivation one year after an interprofessional educational intervention for undergraduate medical and nursing students.

BACKGROUND: The increasingly complex patient care in the twenty-first century is delivered by interprofessional health care teams. Interprofessional collaboration can be taught during interprofessional education. However, whether a long-term change in collaborative competencies can be achieved by interprofessional education has not been studied sufficiently. Our research questions were: How does motivation for interprofessional collaboration and interprofessional collaborative skills change up to one year after an interprofessional educational intervention? How are they related to each other? METHODS: During a one-year period, undergraduate medical and nursing students attended four interprofessional (intervention) or uniprofessional (control group) education sessions. Self-determination Theory was used as the theoretical framework. Autonomous and controlled motivation scores for interprofessional collaboration were calculated using the Academic Self-Regulation Questionnaire, before (T1), directly after (T2) and one year post-intervention (T3). At T3, the students also filled out the Interprofessional Collaborative Competencies Attainment Survey (ICCAS), which measured the perceived attainment of collaborative competencies by a retrospective pre-test/post-test design. We used linear mixed effects models to analyse the motivation scores and linear regression for the relation between motivation and competence. RESULTS: In the interprofessional group, autonomous motivation scores of the participants were significantly lower at T2 vs. T1. Controlled motivation scores were significantly higher at T3 vs. T1. Controlled motivation scores for T2 were significantly higher in the uniprofessional group than in the interprofessional group. Perceived competence was related to higher autonomous motivation scores. At T3 the interprofessional collaborative competencies seemed to have grown more among students in the interprofessional group. CONCLUSIONS: The perceived growth in interprofessional collaboration competence lasted at least up to one year after the intervention, and was measurable with the ICCAS. The growth was significantly more in the IPE students than in the UPE students. The few differences found in motivation scores for interprofessional collaboration were probably caused by an imbalance of nursing versus medical students over the different time points. This finding indicates that classroom based IPE can contribute to interprofessional collaboration skills of nursing and medical students at least up to one year after an intervention.

Community-based prehabilitation in older patients and high-risk patients undergoing colorectal cancer surgery.

INTRODUCTION: Prehabilitation before colorectal cancer (CRC) surgery is promising to prevent complications and to enhance recovery, especially in patients aged 70 or older or in patients with an American Society of Anaesthesiologist (ASA) physical classification score 3-4, for whom surgery is associated with higher postoperative complications and long-lasting adverse effects on functional performance. MATERIALS AND METHODS: A cohort study was conducted in a large teaching hospital in Alkmaar, the Netherlands. Fifty CRC patients (≥70 years or ASA 3-4) underwent multimodal prehabilitation between September 2020 and July 2021. The reference group comprised 50 patients (≥70 years or ASA 3-4) from a historical cohort receiving CRC surgery without prehabilitation (March 2020-August 2020). The primary outcome was 90-day postoperative complication rate. Secondary outcomes were length of stay, 90-day readmission and mortality rates and functional outcome in the prehabilitation group. RESULTS: One patient in the prehabilitation group decided not to undergo surgery. Of the remaining 49 patients, 48 (98.0 %) received prehabilitation for at least 3 weeks. Of these patients, 32.7 % developed postoperative complications, compared to 58 % in the reference group (p = 0.015), and none were readmitted, in contrast to 6 reference group patients (12.0 %, p = 0.012). Length of stay and mortality did not differ significantly. Six weeks postoperatively, all functional outcomes in the prehabilitation group were significantly higher than at baseline. CONCLUSIONS: Prehabilitation reduced postoperative complications and improved short-term functional outcomes in older and high-risk patients receiving CRC surgery. Further research should investigate the maintenance of long-term enhanced lifestyle and the effects of tailor-made programs.

The INCH-trial: a multicenter randomized controlled trial comparing short- and long-term outcomes of open and laparoscopic surgery for incisional hernia repair.

BACKGROUND: Laparoscopic incisional hernia repair is increasingly performed worldwide and expected to be superior to conventional open repair regarding hospital stay and quality of life (QoL). The INCisional Hernia-Trial was designed to test this hypothesis. METHODS: A multicenter parallel randomized controlled open-label trial with a superiority design was conducted in six hospitals in the Netherlands. Patients with primary or recurrent incisional hernias were randomized by computer-guided block-randomization to undergo either conventional open or laparoscopic repair. Primary endpoint was postoperative length of hospital stay in days. Secondary endpoints included QoL, complications, and recurrences. Patients were followed up for at least 5 years. RESULTS: Hundred-and-two patients were recruited and randomized. In total, 88 patients underwent surgery and were included in the intention-to-treat analysis (44 in the open group, 44 in the laparoscopic group). Mean age was 59.5 years, gender division was equal, and BMI was 28.8 kg/m. The trial was concluded early for futility after an unplanned interim analysis, which showed that the hypothesis needed to be rejected. There was no difference in primary outcome: length of hospital stay was 3 (range 1-36) days in the open group and 3 (range 1-12) days in the laparoscopic group (p = 0.481). There were no significant between-group differences in QoL questionnaires on the short and long term. Satisfaction was impaired in the open group. Overall recurrence rate was 19%, of which 16% in the open and 23% in the laparoscopic group (p = 0.25) at a mean follow-up of 6.6 years. CONCLUSIONS: In a randomized controlled trial, short- and long-term outcomes after laparoscopic incisional hernia repair were not superior to open surgery. The persisting high recurrence rates, reduced QoL, and suboptimal satisfaction warrant the need for patient's expectation management in the preoperative process and individualized surgical management. TRIAL REGISTRATION: Netherlands Trial Register NTR2808.

How does interprofessional education influence students' perceptions of collaboration in the clinical setting? A qualitative study.

BACKGROUND: Interprofessional education (IPE) aims to improve students' collaborative competencies and behaviour. The effect of classroom IPE on students' perceptions of collaboration in clinical practice, and how knowledge is possibly transferred, has yet to be investigated. The research question of this study was: How does IPE in a classroom setting influence students' perceptions of collaboration in clinical practice? Social capital theory is used as the theoretical lens. Social capital theory describes how social relationships generate benefits for the individuals involved. Social capital can be divided into three forms of social cohesion: bonding, bridging and linking social capital. Bonding refers to connections that are close and strong, such as family. Bridging social capital occurs in more distant relationships. Linking social capital refers to relationships between individuals with different power or social status. METHODS: A qualitative study with semi-structured face-to-face interviews was conducted to explore students' perceptions and experiences. Nursing and medical students who had participated in four classroom IPE-sessions were asked about the perceived influence of the IPE-sessions they had attended on their interprofessional collaboration. Thematic analysis was conducted, with sensitising concepts of 'bonding', 'bridging' and 'linking social capital' from the social capital theory. RESULTS: Twenty-two interviews were conducted. Students experienced: 1) exchange of discipline specific knowledge, 2) general knowledge about each other's responsibilities, 3) reduction of hierarchy, and 4) improvement in patient care. The first two themes reflect bridging social capital, since students experience that the other student is from a different group. The third theme reflects linking social capital, since students experience a difference in (social) status. The fourth theme most explicitly reflects 'getting ahead' or doing better, what is referred to as an effect of increased social capital. CONCLUSION: This study reveals new insights regarding how increased social capital of undergraduate students after IPE-sessions in a classroom setting influences the way they conceptualise and experience interprofessional collaboration in clinical practice. These insights contribute to the understanding of the effectiveness of IPE in undergraduate curricula. Further research on long-term effects is underway.

The Validation of Geriatric Cases for Interprofessional Education: A Consensus Method.

BACKGROUND: Case-based Interprofessional Education (IPE) can help students practise their roles and responsibilities. To construct these cases, input from experts in clinical practice is essential. Consensus between these experts can be facilitated using consensus methods. In this study, a geriatric focus for the cases was chosen because of the interprofessional nature of geriatrics and the ageing population in healthcare facilities. METHODS: By combining the 3 most commonly used consensus methods, we developed a 6-step approach to validate cases for IPE. The 6 steps include 3 expert rounds (Steps 1, 3 and 5) and 2 rounds in which discussion points were formulated by the researcher (Steps 2 and 4). The cases were piloted with students as Step 6. Four facets of a case were included: the patient description, the complemented treatment plan, the difficulty of the case and the scoring of the treatment plan. Our educational setting required constructing 4 cases with increasing difficulty. Results: Step 1: 5 typical geriatric cases were assembled. Step 2: Similar characteristics were defined; 5 cases were merged into 4. The 4 cases showed increasing difficulty levels. Step 3: The constructed cases were validated for patient description authenticity, treatment plan adequacy, difficulty and scoring of the treatment plan. Step 4: The items for further discussion were defined. Step 5: Consensus was reached for all 4 cases through a face-to-face discussion. Step 6: The student pilot for Case 1 showed no significant adjustments. CONCLUSION: We developed a 6-step consensus method to validate cases for IPE, and we constructed 4 geriatric cases based on this method. While consensus about the patient descriptions and difficulty levels was reached easily, consensus on the treatment plans was more difficult to achieve. Validation of the scoring of the treatment plan was unsuccessful. Further research on this will be conducted.

Variation in length of stay after minimally invasive lung resection: a reflection of perioperative care routines?

OBJECTIVES: Good perioperative care is aimed at rapid recovery, without complications or readmissions. Length of stay (LOS) is influenced not only by perioperative care routines but also by patient factors, tumour factors, treatment characteristics and complications. The present study examines variation in LOS between hospitals after minimally invasive lung resections for both complicated and uncomplicated patients to assess whether LOS is a hospital characteristic influenced by local perioperative routines or other factors. METHODS: Dutch Lung Cancer Audit (surgery) data were used. Median LOS was calculated on hospital level, stratified by the severity of complications. Lowest quartile (short) LOS per hospital, corrected for case-mix factors by multivariable logistic regression, was presented in funnel plots. We correlated short LOS in complicated versus uncomplicated patients to assess whether short LOS clustered in the same hospitals regardless of complications. RESULTS: Data from 6055 patients in 42 hospitals were included. Median LOS in uncomplicated patients varied from 3 to 8 days between hospitals and increased most markedly for patients with major complications. Considerable between-hospital variation persisted after case-mix correction, but more in uncomplicated than complicated patients. Short LOS in uncomplicated and complicated patients were significantly correlated (r = 0.53, P < 0.001). CONCLUSIONS: LOS after minimally invasive anatomical lung resections varied between hospitals particularly in uncomplicated patients. The significant correlation between short LOS in uncomplicated and complicated patients suggests that LOS is a hospital characteristic potentially influenced by local processes. Standardizing and optimizing perioperative care could help limit practice variation with improved LOS and complication rates.

Can We Identify or Exclude Extensive Axillary Nodal Involvement in Breast Cancer Patients Preoperatively?

BACKGROUND: Breast cancer treatment has rapidly changed in the last few years. Particularly, treatment of patients with axillary nodal involvement has evolved after publication of several randomized clinical trials. Omitting axillary lymph node dissection in selected early breast cancer patients with one or two positive sentinel nodes did not compromise overall survival nor regional disease control in these trials. Hence, either excluding or identifying extensive axillary nodal involvement becomes increasingly important. PURPOSE: To evaluate whether the current diagnostic modalities can accurately identify or exclude extensive axillary nodal involvement. Evaluated modalities were axillary ultrasound, ultrasound-guided needle biopsy, MRI, and PET/CT. METHODS: A literature search was performed in the Cochrane Library, EMBASE, and PubMed databases up to June 2019. The search strategy included terms for breast cancer, lymph nodes, and the different imaging modalities. Only articles that reported pathological N-stage or the total number of positive axillary lymph nodes were considered for inclusion. Studies with patients undergoing neoadjuvant systemic therapy were excluded. CONCLUSION: There is no evidence that any of the current preoperative axillary imaging modalities can accurately exclude or identify breast cancer patients with extensive nodal involvement. Both negative PET/CT and negative MRI scans (with gadolinium-based contrast agents) are promising in excluding extensive nodal involvement. Larger studies should be performed to strengthen this conclusion. False-negative rates of axillary ultrasound and ultrasound-guided needle biopsy are too high to rely on negative results of these modalities in excluding extensive nodal involvement.

Evaluation of PET/CT in patients with stage III malignant cutaneous melanoma.

In order to evaluate if patients with stage III-IV MCM are eligible for curative treatment PET/CT is performed. Since the diagnostic value of PET/CT is not unambiguously, a retrospective cohort study is performed to tailor optimal indication of PET/CT in patients with stage III MCM. A retrospective cohort study was conducted of all patients with stage III disease in a large oncologic teaching hospital in which PET/CT was performed from 2012 to 2016. The primary tumor- and regional lymph node characteristics were assessed to predict distant metastasis seen on PET/CT. A total of 73 patients were included of which 18% were restaged as stage IV by PET/CT. Twenty percent of the patients with a positive lymph node and 14% of patients with in transit metastasis or satellite lesions were restaged to stage IV. T-classification, ulceration and N-classification did not predict distant metastasis. Localization of the primary tumor significantly differed (P = 0.004). Localization on the head/neck resulted in a 32 greater odds of distant metastasis (P = 0.008). After a median follow-up of 36 months, 13 out of 60 (27%) stage III MCM patients were restaged as stage IV after the first performed PET/CT. This retrospective cohort study resulted in restaging of 18% of the stage III MCM patients by PET/CT, with therapeutic consequences. Patients with stage III MCM on the head/neck seem to have more distant spreading of the tumor than other localizations. Further investigation is needed, with larger sample sizes, to guide optimal indication of PET/CT.

Uniportal video-assisted thoracic surgery lobectomy: a consensus report from the Uniportal VATS Interest Group (UVIG) of the European Society of Thoracic Surgeons (ESTS).

OBJECTIVES: Our goal was to report the results of the first consensus paper among international experts in uniportal video-assisted thoracoscopic surgery (UniVATS) lobectomy obtained through a Delphi process, the objective of which was to define and standardize the main procedural steps, optimize its indications and perioperative management and identify elements to assist in future training. METHODS: The 40 members of the working group were convened and organized on a voluntary basis by the Uniportal VATS Interest Group (UVIG) of the European Society of Thoracic Surgeons (ESTS). An e-consensus finding exercise using the Delphi method was applied to require 75% agreement for reaching consensus on each question. Repeated iterations of anonymous voting continued for 3 rounds. RESULTS: Overall, 31 international experts from 18 countries completed all 3 rounds of questionnaires. Although a technical quorum was not achieved, most of the responders agreed that the maximum size of a UniVATS incision should be ≤4 cm. Agreement was reached on many points outlining the currently accepted definition of a UniVATS lobectomy, its indications and contraindications, perioperative clinical management and recommendations for training and future research directions. CONCLUSIONS: The UVIG Consensus Report stated that UniVATS offers a valid alternative to standard VATS techniques. Only longer follow-up and randomized controlled studies will predict whether UniVATS represents a valid alternative approach to multiport VATS for major lung resections or whether it should be performed only in selected cases and by selected centres. The next step for the ESTS UVIG is the establishment of a UniVATS section inside the ESTS databases.

Yield of Surveillance Colonoscopies 1 Year After Curative Surgical Colorectal Cancer Resections.

BACKGROUND & AIMS: Endoscopic surveillance after curative colorectal cancer (CRC) resection is routine. However, there is controversy whether the 1-year interval between preoperative and postoperative colonoscopy is justified owing to improved colonoscopy standards. We aimed to assess the yield of surveillance colonoscopies 1 year after CRC surgery. METHODS: We performed a retrospective cohort study of 572 patients (54.9% male; mean age, 66.2 ± 9.9 y), who underwent curative surgical resection of a first CRC from June 2013 through April 2016 in the Northwest region of The Netherlands. Patients were included if a complete clearing colonoscopy was performed before surgery and the interval between the preoperative and postoperative colonoscopy was 12 months (range, 6-20 mo), conforming to Dutch guidelines. The primary outcome of the study was the yield of CRC at the surveillance colonoscopy performed 1 year after curative resection. A secondary outcome was the yield of advanced neoplasia. RESULTS: After a mean surveillance interval of 13.7 months (±2.8 mo), 10 of 572 patients (1.7%; 95% CI, 0.7%-2.8%) received a diagnosis of CRC. Of these, 5 CRCs were apparently metachronous cancers (3 were stage III or IV) and 5 were recurrences at the anastomosis (1 was stage IV). In 11.4% of patients (95% CI, 8.9%-13.8%), advanced neoplasia was detected at the 1-year follow-up colonoscopy. Synchronous advanced neoplasia at baseline colonoscopy was a risk factor for detection of advanced neoplasia at the follow-up colonoscopy (odds ratio, 2.2; 95% CI, 1.3-3.8; P ≤ .01). CONCLUSIONS: Despite high colonoscopy quality, the yield of CRC at surveillance colonoscopy 1 year after CRC resection was 1.7%. These were metachronous CRCs and recurrences, often of advanced stage. The high yield justifies the recommendation of a 1-year surveillance interval after surgical CRC resection.

Adrenal Incidentalomas During Diagnostic Work-up of Colorectal Cancer Patients: What is the Risk of Metastases?

BACKGROUND: Adrenal incidentalomas (AIs) are regularly discovered on staging computed tomography (CT) of patients with colorectal cancer (CRC). Although CRC is considered unlikely to metastasize to the adrenal gland, it is not known how often an AI appears to be a CRC metastasis. This causes a diagnostic dilemma for many patients with newly diagnosed CRC. This study aimed primarily to describe the incidence of AIs and adrenal metastases in CRC patients. METHODS: A single-center cohort of 475 consecutive patients with newly diagnosed CRC was defined. Retrospectively, all radiology reports and multidisciplinary team meeting reports were assessed for the presence of adrenal abnormalities. All AIs shown on staging CT were reevaluated for the purpose of this study, and the sizes of these adrenal glands were determined. Based on the CT reevaluation, follow-up imaging, and clinical follow-up assessment, conclusions on the presence or absence of adrenal metastases were drawn. RESULTS: The incidence of AIs in this CRC patient cohort was 10.5% (50/475). In 96% (48/50) of the patients with AIs, adrenal metastases could be ruled out. No solitary adrenal metastases were encountered. In two patients who had widespread systemic disease without curative treatment options, the AIs were considered to be adrenal metastases (cohort incidence, 0.4%). CONCLUSION: This is the first study to report on adrenal incidentalomas in CRC patients. In newly diagnosed CRC patients without disseminated disease, AIs can be considered benign, and no additional imaging is indicated to rule out adrenal metastases in this group.

MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): study protocol of a multicenter randomised controlled trial.

BACKGROUND: In case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings. We hypothesize that omitting mediastinoscopy after negative endosonography in mediastinal staging of NSCLC does not result in an unacceptable percentage of unforeseen N2 disease at surgical resection. In addition, omitting mediastinoscopy comprises no extra waiting time until definite surgery, omits one extra general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life. The aim of this study is to compare the cost-effectiveness and cost-utility of mediastinal staging strategies including and excluding mediastinoscopy. METHODS/DESIGN: This study is a multicenter parallel randomized non-inferiority trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in 360 patients with suspected resectable NSCLC. Patients are eligible for inclusion when they underwent systematic endosonography to evaluate mediastinal lymph nodes including tissue sampling with negative endosonography results. Patients will not be eligible for inclusion when PET/CT demonstrates 'bulky N2-N3' disease or the combination of a highly suspicious as well as irresectable mediastinal lymph node. Primary outcome measure for non-inferiority is the proportion of patients with unforeseen N2 disease at surgery. Secondary outcome measures are hospitalization, morbidity, overall 2-year survival, quality of life, cost-effectiveness and cost-utility. Patients will be followed up 2 years after start of treatment. DISCUSSION: Results of the MEDIASTrial will have immediate impact on national and international guidelines, which are accessible to public, possibly reducing mediastinoscopy as a commonly performed invasive procedure for NSCLC staging and diminishing variation in clinical practice. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register on July 6th, 2017 ( NTR 6528 ).

The use of PET-MRI in the follow-up after radiofrequency- and microwave ablation of colorectal liver metastases.

BACKGROUND: Thermal ablation of colorectal liver metastases (CRLM) may result in local progression, which generally appear within a year of treatment. As the timely diagnosis of this progression allows potentially curative local treatment, an optimal follow-up imaging strategy is essential. PET-MRI is a one potential imaging modality, combining the advantages of PET and MRI. The aim of this study is evaluate fluorine-18 deoxyglucose positron emission tomography (FDG) PET-MRI as a modality for detection of local tumor progression during the first year following thermal ablation, as compared to the current standard, FDG PET-CT. The ability of FDG PET-MRI to detect new intrahepatic lesions, and the extent to which FDG PET-MRI alters clinical management, inter-observer variability and patient preference will also be included as secondary outcomes. METHODS/DESIGN: Twenty patients undergoing treatment with radiofrequency or microwave ablation for (recurrent) CRLM will be included in this prospective trial. During the first year of follow-up, patients will be scanned at the VU University Medical Center at 3-monthly intervals using a 4-phase liver CT, FDG PET-CT and FDG PET-MRI. Patients treated with chemotherapy <6 weeks prior to scanning or with a contra-indication for MRI will be excluded. MRI will be performed using both whole body imaging (mDixon) and dedicated liver sequences, including diffusion-weighted imaging, T1 in-phase and opposed-phase, T2 and dynamic contrast-enhanced imaging. The results of all modalities will be scored by 4 individual reviewers and inter-observer agreement will be determined. The reference standard will be histology or clinical follow-up. A questionnaire regarding patients' experience with both modalities will also be completed at the end of the follow-up year. DISCUSSION: Improved treatment options for local site recurrences following CRLM ablation mean that accurate post-ablation staging is becoming increasingly important. The combination of the sensitivity of MRI as a detection method for small intrahepatic lesions with the ability of FDG PET to visualize enhanced metabolism at the ablation site suggests that FDG PET-MRI could potentially improve the accuracy of (early) detection of progressive disease, and thus allow swifter and more effective decision-making regarding appropriate treatment. TRIAL REGISTRATION NUMBER: NCT01895673.

Axillary staging by ultrasound-guided fine-needle aspiration cytology in breast cancer patients. Still up to date?

To investigate whether clinicopathological features of breast cancer patients could predict the likelihood of lymph node metastases and the likelihood of false-negative results of ultrasound-guided fine-needle aspiration cytology of suspicious lymph nodes (US+FNAC). Between 2004 and 2009, US+FNAC was performed in 1,150 axillae (18 bilateral breast carcinomas). Based on final histologic diagnosis, the true- and false-negative group of US+FNAC were defined. Subsequently, 11 clinicopathological factors were compared between these two groups. These factors were also compared between patients with and patients without lymph node metastases. Of 1,150 axillae, 429 had lymph node metastases at final histology. US+FNAC indicated metastases in 107 axillae. 1,043 axillae were negative by US+FNAC. Final histology showed metastases in 323 of these 1,043 axillae, resulting in a false-negative group of US+FNAC of 31%. Both age <60 years and a cT2/cT3 breast carcinoma were significantly associated with lymph node metastases and with false-negative results of US+FNAC. Lymph node metastases were found in 59.6% of patients <60 years with a cT2/cT3 breast carcinoma. In these patients, 52.3% of the negative US+FNAC results were falsely negative. In patients <60 years with a cT2/cT3 breast carcinoma, we recommend to omit US+FNAC preoperatively and perform a SNB directly, because lymph node metastases were found in 59.6% of these patients and 52.3% of negative US+FNAC results were falsely negative.

The INCH-Trial: a multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional hernia repair.

BACKGROUND: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. METHODS/DESIGN: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life. DISCUSSION: The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach. TRIAL REGISTRATION: Netherlands Trial register: NTR2808.

Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial).

BACKGROUND: Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. METHODS/DESIGN: In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. CONCLUSION: The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR): NTR2579.