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.

Quality of life in elderly patients with an ostomy - a study from the population-based PROFILES registry.

AIM: Ostomies are being placed frequently in surgically treated elderly patients with colorectal cancer (CRC). An insight into the (potential) impact of ostomies on quality of life (QoL) could be useful in patient counselling as well as in the challenging shared treatment decision-making. METHOD: Patients with CRC diagnosed between 2000 and 2009 and registered in the population-based Eindhoven Cancer Registry received a QoL questionnaire (EORTC QLQ-C30) in 2010. In addition, QoL was compared with an age- and sex-matched normative population. RESULTS: The study included 2299 CRC patients, of whom 494 had an ostomy. No differences were found in reported ostomy-related problems between patients aged ≤65, 66-75 and ≥76 years. Ostomy patients aged 66-75 and ≥76 years reported significantly lower physical functioning compared with those without an ostomy. In the elderly (those aged ≥76 years) ostomates reported a worse physical and social functioning compared with the normative population. All these differences were of small clinical relevance. The impact of an ostomy seems to be more prominent in younger (≤75 years old) ostomates, as they experience more functional limitations and a decrease in global health status compared with younger nonostomy patients and the normative population. CONCLUSION: Although elderly (≥76 years old) patients with an ostomy report significantly more limitations in functioning compared with a normative population and elderly CRC patients without an ostomy, the clinical relevance of this finding is limited. In contrast, the impact of an ostomy is more prominent in younger patients. Thus, age itself is not a reason for withholding an ostomy.

The effect of a geriatric evaluation on treatment decisions for older patients with colorectal cancer.

BACKGROUND: Treating elderly colorectal cancer patients can be challenging. It is very important to carefully weigh the risks and benefits of potential treatments in individual patients. This treatment decision making can be guided by geriatric consultation. Our aim was to assess the effect of a geriatric evaluation on treatment decisions for older patients with colorectal cancer. METHODS: Colorectal cancer patients who were referred for a geriatric consultation between 2013 and 2015 in three Dutch teaching hospitals were included in a prospective database. The outcome of geriatric assessment, non-oncological interventions and geriatricians' treatment recommendations were evaluated. RESULTS: The total number of included referrals was 168. The median age was 81 years (range 60-94). Most patients (71%) had colon cancer and 49% had tumour stage III disease. The reason for geriatric consultation was uncertainty regarding the optimal oncologic treatment in 139 patients (83%). Overall 93% of patients suffered from geriatric impairments; non-oncological interventions that followed after geriatric consultation was mostly aimed at malnutrition. The geriatrician recommended the 'more intensive treatment' option in 69% and the 'less intensive treatment' option in 31% of which 63% 'supportive care only'. CONCLUSION: Geriatric consultation can be useful in treatment decision making in elderly patients with colorectal cancer. It may lead to changes in the treatment plan for individual cases and may result in an additional optimisation of patient's health status prior to treatment.

Transanal minimally invasive surgery for rectal polyps and selected malignant tumors: caution concerning intermediate-term functional results.

PURPOSE: Transanal minimally invasive surgery (TAMIS) is gaining worldwide popularity as an alternative for the transanal endoscopic microsurgery (TEMS) method for the local excision of rectal polyps and selected neoplasms. Data on patient reported outcomes regarding short-term follow-up are scarce; data on functional outcomes for long-term follow-up is non-existent. METHODS: We used the fecal incontinence severity index (FISI) to prospectively assess the fecal continence on the intermediate-term follow-up after TAMIS. The primary outcome measure is postoperative fecal continence. Secondary outcome measures are as follows: perioperative and intermediate-term morbidity. RESULTS: Forty-two patients (m = 21:f = 21), median age 68.5 (range 34-94) years, were included in the analysis. In four patients (9.5%), postoperative complications occurred. The median follow-up was 36 months (range 24-48). Preoperative mean FISI score was 8.3 points. One year after TAMIS, mean FISI score was 5.4 points (p = 0.501). After 3 years of follow-up, mean FISI score was 10.1 points (p = 0.01). Fecal continence improved in 11 patients (26%). Continence decreased in 20 patients (47.6%) (mean FISI score 15.2 points, [range 3-31]). CONCLUSIONS: This study found that the incidence of impaired fecal continence after TAMIS is substantial; however, the clinical significance of this deterioration seems minor. The present data is helpful in acquiring informed consent and emphasizes the need of proper patient information. Functional results seem to be comparable to results after TEMS. Furthermore, we confirmed TAMIS is safe and associated with low morbidity.

The impact of an ostomy on older colorectal cancer patients: a cross-sectional survey.

BACKGROUND: Ostomies are being placed in 35 % of patients after colorectal cancer surgery. As decision-making regarding colorectal surgery is challenging in the older patients, it is important to have insight in the potential impact due to ostomies. METHODS: An internet-based survey was sent to all members with registered email addresses of the Dutch Ostomy Patient Association. RESULTS: The response rate was 49 %; 932 cases were included of whom 526 were aged <70 years old ("younger respondents"), 301 were aged between 70 and 79 years old ("the elderly"), and 105 were aged ≥80 years old ("oldest old"). Ostomy-related limitations were similar in the different age groups, just as uncertainty (8-10 %) and dependency (18-22 %) due to the ostomy. A reduced quality of life was experienced least in the oldest old group (24 % vs 37 % of the elderly and 46 % of the younger respondents, p < 0.001). Over time, a decrease of limitations and impact due to the ostomy was observed. CONCLUSION: Older ostomates do not experience more limitations or psychosocial impact due to the ostomy compared to their younger counterparts. Over the years, impact becomes less distinct. Treatment decision-making is challenging in the older colorectal cancer patients but ostomy placement should not be withheld based on age alone.

Colorectal Cancer Resections in the Oldest Old Between 2011 and 2012 in The Netherlands.

INTRODUCTION: Adequate decision-making in elderly colorectal cancer patients requires accurate information regarding risks of treatment. We analysed the outcome and survival of colorectal resections in the oldest old (≥85 years). METHODS: An analysis of the 2011-2012 data from two large nationwide registries: the Dutch Surgical Colorectal Audit (DSCA), containing all colorectal cancer resections, and the Netherlands Cancer Registry (NCR), containing survival data for all newly diagnosed malignancies. RESULTS: The study included more than 1200 patients aged ≥85 years (DSCA n = 1232, NCR n = 1206). The postoperative complication rate was 41 % in the oldest old. The frequency of cardiopulmonary complications rose rapidly with age, from 11 % in those <70 years to 38 % for the oldest old (p < 0.001). Postoperative 30-day mortality rate was 10 % in the oldest old. Three-month mortality was 14 % (compared with 3 % of patients <85 years; p < 0.001). One-year mortality was 24 % and 2-year mortality 36 %. After correction for expected mortality in the general population, excess mortality for the oldest old was 12 % in the first year and 3 % in the second year. CONCLUSIONS: In this study of more than 1200 colorectal cancer patients aged ≥85 years undergoing surgical resection, we found high rates of cardiopulmonary complications and excess mortality, particularly in the first year after surgery. We propose that these data could be incorporated into individualized treatment algorithms, which also include detailed information regarding the patients' health status.

Geriatric consultation can aid in complex treatment decisions for elderly cancer patients.

Treatment decisions for elderly cancer patients can be challenging. A geriatric assessment may identify unknown medical conditions, give insight on patients' ability to tolerate treatment and guide treatment decisions. Our aim was to study the value of a geriatric consultation in oncological decision-making. Data on cancer patients referred for geriatric consultation for clinical optimisation or due to uncertainty regarding their optimal treatment strategy were prospectively analysed. Outcome of geriatric evaluations, non-oncological interventions and suggested adaptations of oncological treatment proposals were evaluated. Seventy-two patients were referred for consultation, over half of which in a curative treatment setting. Prevalence of geriatric syndromes was 93%, previously undiagnosed conditions were identified in 49% of patients and non-oncological interventions were initiated in 56%. Time was spent discussing patients' priorities (53% of consultations), expectations on treatment (50%) and advance care planning (14%). For 82% of patients, suggestions were made regarding the optimal treatment decision: a more intensive treatment was recommended in 39%, a less intensive therapy for 42% and in 19% only supportive care was suggested. The results demonstrate that a geriatric consultation can aid in complex treatment decisions and may allow for a reduction in over- and undertreatment of elderly cancer patients.

Short-term follow-up after laparoscopic versus conventional total mesorectal excision for low rectal cancer in a large teaching hospital.

PURPOSE: Laparoscopic resection for low rectal cancer remains controversial, and large randomized studies on oncologic outcome are lacking. The objective of this study was to analyze the short-term results of laparoscopic resection versus conventional total mesorectal excision (TME) for low rectal cancer (≤10 cm from the anal verge). METHODS: The institutional colorectal surgery database was reviewed, and 166 consecutive patients operated for low rectal cancer between 2006 and 2011 were included in this analysis which focuses on the first 18 months of follow-up. RESULTS: Eighty patients underwent conventional TME, whereas 86 patients underwent laparoscopic TME. Patient characteristics were comparable between groups. Conversion rate was 17 %. Laparoscopic rectal resection resulted in significantly less blood loss (200 versus 475 ml, p = <0.001) and a 3-day shorter hospital stay (median, 7 versus 10 days; p = 0.06). Oncologic results from resected specimens were comparable, although significantly more lymph nodes were harvested in laparoscopic resections (median, 13 versus 11; p = 0.005). Disease-free survival after curative resection was better in the laparoscopic group (p = 0.04), but this was no longer significant after correction for potential confounders. CONCLUSIONS: This analysis of short-term results of laparoscopic versus conventional TME for low rectal cancer demonstrates that laparoscopic surgery is feasible and safe, resulting in similar oncologic outcomes with less blood loss, a trend towards less postoperative complications and shorter duration of hospital stay. Further randomized studies are needed to attribute to the body of evidence of equivalence or even superiority of laparoscopic resections compared to conventional resections for distal rectal cancer.

Representation of the elderly in trials of laparoscopic surgery for colorectal cancer.

AIM: Most patients with colorectal cancer are elderly, but there are few data on the optimal surgical treatment for this age group and most studies are observational. We have reviewed the characteristics of randomized trials reporting laparoscopic surgery for colorectal cancer to determine the degree to which the elderly are represented. METHOD: A search was conducted of the NIH clinical trial registry and the ISRCTN register for randomized trials on laparoscopic surgery for colorectal cancer. Trial characteristics and end-points were extracted from the registry website and supplemented by published results where available. RESULTS: Of 52 trial protocols the majority did not state any restrictions regarding cardiac [40 (77%)] or pulmonary function [41 (79%)]. More than half [30 (58%)] had no restrictions regarding American Society of Anesthesiologists score. Twenty-three (44%) trials excluded the elderly either simply on age or by comorbidity or organ function. When an upper age limit was set, half of the studies had no restriction regarding organ function, indicating that chronological age rather than physical condition was taken as the reason for exclusion. In 45 (86%) of the trials the average age of participants was < 70 years, and no details of concurrent disease were given. CONCLUSION: Participation of the elderly in trials of laparoscopic surgery for colorectal cancer is very limited. This should be remedied in future trials if adequate information on the majority of patients with colorectal cancer is to be obtained.

Health-related quality-of-life trajectories during/after surgery and adjuvant chemotherapy in patients with colon cancer.

PURPOSE: This study aims to evaluate quality of life trajectory during the first year after surgical treatment in patients with resectable primary colon cancer. METHODS: Patients with resectable primary colon cancer diagnosed between 2013 and 2019 who received surgical treatment and adjuvant chemotherapy if indicated were selected from the Prospective Dutch ColoRectal Cancer cohort study (PLCRC). Health-related quality of life (HR-QoL) was assessed using EORTC-QLQ-C30 questionnaire before surgery, and three and twelve months after surgery. HR-QoL scores varied between 0 and 100 and outcomes were compared according to age (< 70 years, ≥ 70 years), comorbidity (yes, no) and treatment type (adjuvant chemotherapy, surgical treatment only). The extent of resilience, defined as a recovery of HR-QoL to baseline level after a clinically relevant decline in HR-QoL at months, was calculated twelve months post-surgery. RESULTS: For all 458 patients, the mean age was 66.4 years (SD 9.5), 40% were aged 70 years and older and 68% were men. Baseline level of HR-QoL summary score was relatively high with a mean of 87.9 (SD 11.5), and did not significantly differ between older and younger patients. The strongest decline of HR-QoL compared to baseline was observed at three months with a gradual recovery over time. Fourteen percent of all patients were non-resilient or showed a late decline at twelve months post-surgery. Compared to younger patients, older patients who received adjuvant chemotherapy were less resilient (respectively, 53 and 32%, p = 0.07) and at risk of a late decline in HR-QoL 1 year post-surgery (respectively, 3% versus 16%, p = 0.02). Comorbidity status had no significant impact on the HR-QoL trajectory. CONCLUSION: Colon cancer treatment was associated with a decline in HR-QoL three months post-surgery, but most patients return to baseline level within twelve months. Still, particularly older patients who received adjuvant chemotherapy were less resilient and at risk of a late decline in HR-QoL. These data could help in patients counselling regarding colon cancer treatment.

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 > 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.

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 < 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 <0.01). Ten patients (36%) mentioned subjective recurrence of complaints, however, physical functioning improved on all HAGOS subscales (p <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.

[Symptomatic gallstone disease: an indication for surgery]. / Symptomatisch galsteenlijden: een operatie-indicatie.

Three patients, men in the ages of 58, 66 and 56 years, respectively, had experienced 'warning colics' a considerable time before gallstone complications or severe recurrent colic. Ultrasonographically proven gallstones had not led to cholecystectomy. The 58-year-old man died of sepsis due to infected pancreatic necrosis; the other men underwent laparoscopic cholecystectomy, after which they recovered fully. Approximately 10-5% of the adult Dutch population have gallstones, but only 10% will develop symptoms. The annual risk for developing complicated gallstone disease is 1-2% in asymptomatic gallstone carriers. Of patients admitted with complicated gallstone disease, 58% have had prior 'warning colics'. Complicated gallstone disease can be prevented by timely treatment after recognition of warning colics. Cholecystectomy is indicated in patients with intermittent upper-abdominal pain and proven gallstones or sludge.

[Colorectal cancer surgery in the oldest Dutch patients: retrospective analysis of two national databases covering 2011 and 2012]. / Darmkankerchirurgie bij de oudste Nederlanders.

OBJECTIVE: Adequate decision-making concerning elderly patients with colorectal cancer requires accurate information regarding the risks of treatment. We analysed the post-operative outcomes and survival following colorectal resections in the oldest old patients (≥ 85 years old). DESIGN: Retrospective study. METHOD: We analysed the data from 2011 and 2012 of all patients with colorectal carcinoma, stage I-III, from two national databases, namely the Dutch Surgical Colorectal Audit registry (DSCA) and the Netherlands Cancer Registry (NKR). RESULTS: The study included over 1200 elderly patients. The postoperative complication rate was 41%. The frequency of cardiopulmonary complications rose rapidly with age, from 11% in those < 70 years to 38% in those aged > 85 years. The postoperative 30-day mortality rate was 10% for the oldest old patients, whereas it was 14% after three months, 24% after one year and 36% after two years. After correction for expected mortality in the general population, excess mortality for the oldest old was 12% in the first year and 3% in the second year. CONCLUSION: For patients aged ≥ 85 years who undergo surgical resection for colorectal carcinoma, high rates of cardiopulmonary complications and excess mortality in the first year after surgery are observed. We propose that these data could be analysed together with information regarding individual patients' health status, to enable optimisation of future decision-making regarding potential surgical intervention in elderly patients.

Non-surgical complications after laparoscopic and open surgery for colorectal cancer - A systematic review of randomised controlled trials.

BACKGROUND: Cardiac and pulmonary complications account for a large part of postoperative mortality, especially in the growing number of elderly patients. This review studies the effect of laparoscopic surgery for colorectal cancer on short term non-surgical morbidity. METHODS: A literature search was conducted to identify randomised trials on laparoscopic compared to open surgery for colorectal cancer with reported cardiac or pulmonary complications. RESULTS: The search retrieved 3302 articles; 18 studies were included with a total of 6153 patients. Reported median or mean age varied from 56 years to 72 years. The percentage of included patients with ASA-scores ≥ 3 ranged from 7% to 38%. Morbidity was poorly defined. Overall reported incidence of postoperative cardiac complications was low for both laparoscopic and open colorectal resection (median 2%). There was a trend towards fewer cardiac complications following laparoscopic surgery (OR 0.66, 95% CI 0.41-1.06, p = 0.08), and this effect was most marked for laparoscopic colectomy (OR 0.28, 95% CI 0.11-0.71, p = 0.007). Incidence of pulmonary complications ranged from 0 to 11% and no benefit was found for laparoscopic surgery, although a possible trend was seen in favour of laparoscopic colectomy (OR 0.78, 95% CI 0.53-1.13, p = 0.19). Overall morbidity rates varied from 11% to 69% with a median of 33%. CONCLUSION: Although morbidity was poorly defined, for laparoscopic colectomies, significantly less cardiac complications occurred compared with open surgery and a trend towards less pulmonary complications was observed. Subgroup analysis from two RCTs suggests that elderly patients benefit most from a laparoscopic approach based on overall morbidity rates.