Athletes treated for inguinal-related groin pain by endoscopic totally extraperitoneal (TEP) repair:long-term benefits of a prospective cohort

Purpose: Inguinal-related groin pain (IRGP) in athletes is a multifactorial condition, posing a therapeutic challenge. If conservative treatment fails, totally extraperitoneal (TEP) repair is effective in pain relief. Because there are only few long-term follow-up results available, this study was designed to evaluate effectiveness of TEP repair in IRGP-patients years after the initial procedure. Methods: Patients enrolled in the original, prospective cohort study (TEP-ID-study) were subjected to two telephone questionnaires. The TEP-ID-study demonstrated favorable outcomes after TEP repair for IRGP-patients after a median follow-up of 19 months. The questionnaires in the current study assessed different aspects, including, but not limited to pain, recurrence, new groin-related symptoms and physical functioning measured by the Copenhagen Hip and Groin Outcome Score (HAGOS). The primary outcome was pain during exercise on the numeric rating scale (NRS) at very long-term follow-up.Results: Out of 32 male participants in the TEP-ID-study, 28 patients (88%) were available with a median follow-up of 83 months (range: 69–95). Seventy-five percent of athletes were pain free during exercise (p &lt; 0.001). At 83 months follow-up, a median NRS of 0 was observed during exercise (IQR 0–2), which was significantly lower compared to earlier scores (p &lt;0.01). Ten patients (36%) mentioned subjective recurrence of complaints, however, physical functioning improved on all HAGOS subscales (p &lt;0.05).Conclusion:This study demonstrates the safety and effectivity of TEP repair in a prospective cohort of IRGP-athletes, for whom conservative treatment had failed, with a follow-up period of over 80 months.</p

Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative

Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients. Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future. Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing. Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting

Feasibility of a smartphone application for inguinal hernia care:a prospective pilot study

The Inguinal Hernia Application (IHAPP) is designed to overcome current limitations of regular follow-up after inguinal hernia surgery. It has two goals: Minimizing unnecessary healthcare consumption by supplying patient information and facilitating registration of patient-reported outcome measures (PROMs) by offering simple questionnaires. In this study we evaluated the usability and validity of the app. Patients (≥18 years) scheduled for elective hernia repair were assessed for eligibility. Feasibility of the app was evaluated by measuring patient satisfaction about utilization. Validity (internal consistency and convergent validity) was tested by comparing answers in the app to the scores of the standardized EuraHS-Quality of Life instrument. Furthermore, test-retest reliability was analyzed correlating scores obtained at 6 weeks to outcomes after 44 days (6 weeks and 2 days). During a 3-month period, a total of 100 patients were included. Median age was 56 years and 98% were male. Most respondents (68%) valued the application as a supplementary tool to their treatment. The pre-operative information was reported as useful by 77% and the app was regarded user-friendly by 71%. Patient adherence was mediocre, 47% completed all questionnaires during follow-up. Reliability of the app was considered excellent (α &gt; 0.90) and convergent validity was significant (p = 0.01). The same applies to test-retest reliability (p = 0.01). Our results demonstrate the IHAPP is a useful tool for reliable data registration and serves as patient information platform. However, further improvements are necessary to increase patient compliance in recording PROMs.</p

Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer

Regular physical activity (PA) is associated with improved overall survival (OS) in stage I-III colorectal cancer (CRC) patients. This association is less defined in patients with metastatic CRC (mCRC). We therefore conducted a study in mCRC patients participating in the Prospective Dutch Colorectal Cancer cohort. PA was assessed with the validated SQUASH questionnaire, filled-in within a maximum of 60 days after diagnosis of mCRC. PA was quantified by calculating Metabolic Equivalent Task (MET) hours per week. American College of Sports and Medicine (ACSM) PA guideline adherence, tertiles of moderate to vigorous PA (MVPA), and sport and leisure time MVPA (MVPA-SL) were assessed as well. Vital status was obtained from the municipal population registry. Cox proportional-hazards models were used to study the association between PA determinants and all-cause mortality adjusted for prognostic patient and treatment-related factors. In total, 293 mCRC patients (mean age 62.9±10.6 years, 67% male) were included in the analysis. Compared to low levels, moderate and high levels of MET-hours were significantly associated with longer OS (fully adjusted hazard ratios: 0.491, (95% CI 0.299-0.807, p value=0.005) and 0.485 (95% CI 0.303-0.778, p value=0.003), respectively), as were high levels of MVPA (0.476 (95% CI 0.278-0.816, p value=0.007)) and MVPA-SL (0.389 (95% CI 0.224-0.677, p value<0.001)), and adherence to ACSM PA guidelines compared to non-adherence (0.629 (95% CI 0.412-0.961, p value=0.032)). The present study provides evidence that higher PA levels at diagnosis of mCRC are associated with longer OS

Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): Study protocol for a trial within a cohort study

Background: Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients. Methods/design: MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat. Discussion: The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group. Trial registration: Netherlands Trial Register: NL6281/NTR6455. Registered 18 May 2017, https://www.trialregister.nl/trial/628