Benchmarks in colorectal surgery: multinational study to define quality thresholds in high and low anterior resection.

BACKGROUND: Benchmark comparisons in surgery allow identification of gaps in the quality of care provided. The aim of this study was to determine quality thresholds for high (HAR) and low (LAR) anterior resections in colorectal cancer surgery by applying the concept of benchmarking. METHODS: This 5-year multinational retrospective study included patients who underwent anterior resection for cancer in 19 high-volume centres on five continents. Benchmarks were defined for 11 relevant postoperative variables at discharge, 3 months, and 6 months (for LAR). Benchmarks were calculated for two separate cohorts: patients without (ideal) and those with (non-ideal) outcome-relevant co-morbidities. Benchmark cut-offs were defined as the 75th percentile of each centre's median value. RESULTS: A total of 3903 patients who underwent HAR and 3726 who had LAR for cancer were analysed. After 3 months' follow-up, the mortality benchmark in HAR for ideal and non-ideal patients was 0.0 versus 3.0 per cent, and in LAR it was 0.0 versus 2.2 per cent. Benchmark results for anastomotic leakage were 5.0 versus 6.9 per cent for HAR, and 13.6 versus 11.8 per cent for LAR. The overall morbidity benchmark in HAR was a Comprehensive Complication Index (CCI®) score of 8.6 versus 14.7, and that for LAR was CCI® score 11.9 versus 18.3. CONCLUSION: Regular comparison of individual-surgeon or -unit outcome data against benchmark thresholds may identify gaps in care quality that can improve patient outcome.

Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study.

BACKGROUND: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. METHODS/DESIGN: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. DISCUSSION: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

Introduction of a colorectal cancer screening programme: results from a single-centre study.

AIM: In 2014, a national colorectal cancer (CRC) screening programme was launched in the Netherlands. It is difficult to assess for the individual patients with CRC whether the oncological benefits of surgery will outweigh the morbidity of the procedure, especially in early lesions. This study compares patient and tumour characteristics between screen-detected and nonscreen-detected patients. Also, we present an overview of treatment options and clinical dilemmas when treating patients with early-stage colorectal disease. METHOD: Between January 2014 and December 2016, all patients with nonmalignant polyps or CRC who were referred to the Department of Surgery of the Leiden University Medical Centre in the Netherlands were included. Baseline characteristics, type of treatment and short-term outcomes of patients with screen-detected and nonscreen-detected colorectal tumours were compared. RESULTS: A total of 426 patients were included, of whom 240 (56.3%) were identified by screening. Nonscreen-detected patients more often had comorbidity (P = 0.03), the primary tumour was more often located in the rectum (P = 0.001) and there was a higher rate of metastatic disease (P < 0.001). Of 354 surgically treated patients, postoperative adverse events did not significantly differ between the two groups (P = 0.38). Of 46 patients with T1 CRC in the endoscopic resection specimen, 23 underwent surgical resection of whom only 30.4% had residual invasive disease at colectomy. CONCLUSION: Despite differences in comorbidity, stage and surgical outcome of patients with screen-detected tumours compared to nonscreen-detected tumours were not significantly different. Considering its limited oncological benefits as well as the rate of adverse events, surgery for nonmalignant polyps and T1 CRC should be considered carefully.

Efficacy of eye movement desensitization and reprocessing therapy for fear of cancer recurrence among cancer survivors: a randomized single-case experimental design.

Background: Fear of cancer recurrence (FCR) is one of the greatest problems with which cancer survivors have to deal. High levels of FCR are characterized by intrusive thoughts about cancer-related events and re-experiencing these events, avoidance of reminders of cancer, and hypervigilance, similar to post-traumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) therapy focuses on these images and memories. It is effective in reducing PTSD and may be effective in reducing high levels of FCR.Objective: The aim of the present study is to investigate the effectiveness of EMDR for severe FCR in breast and colorectal cancer survivors.Method: A multiple-baseline single-case experimental design (n = 8) was used. Daily repeated measurements for FCR were taken during the baseline phase and treatment phase, post-treatment, and at the 3 month follow-up. Participants answered the Cancer Worry Scale (CWS) and the Fear of Cancer Recurrence Inventory, Dutch version (FCRI-NL) five times, i.e. at the start and at the end of each phase (baseline, treatment, post-treatment, and follow-up). The study was prospectively registered at clinicaltrials.gov (NL8223).Results: Visual analysis and effect size calculation by Tau-U were executed for the daily questionnaire on FCR. The weighted average Tau-U score was .63 (p < .01) for baseline versus post-treatment, indicating large change, and .53 (p < .01) between baseline and follow-up, indicating moderate change. The scores on the CWS and FCRI-NL-SF decreased significantly from baseline to follow-up.Conclusion: The results seem promising for EMDR therapy as a potentially effective treatment for FCR. Further research is recommended.

Patients who experience high fear of cancer recurrence (FCR) often have intrusive memories and images about (future) cancer-related events.Eye movement desensitization and reprocessing (EMDR) therapy can focus on these intrusions.EMDR therapy is found to be a promising therapy for patients experiencing high FCR.

National cohort study on postoperative risks after surgery for submucosal invasive colorectal cancer.

Background: The decision to perform surgery for patients with T1 colorectal cancer hinges on the estimated risk of lymph node metastasis, residual tumour and risks of surgery. The aim of this observational study was to compare surgical outcomes for T1 colorectal cancer with those for more advanced colorectal cancer. Methods: This was a population-based cohort study of patients treated surgically for pT1-3 colorectal cancer between 2009 and 2016, using data from the Dutch ColoRectal Audit. Postoperative complications (overall, surgical, severe complications and mortality) were compared using multivariable logistic regression. A risk stratification table was developed based on factors independently associated with severe complications (reintervention and/or mortality) after elective surgery. Results: Of 39 813 patients, 5170 had pT1 colorectal cancer. No statistically significant differences were observed between patients with pT1 and pT2-3 disease in the rate of severe complications (8·3 versus 9·5 per cent respectively; odds ratio (OR) 0·89, 95 per cent c.i. 0·80 to 1·01, P = 0·061), surgical complications (12·6 versus 13·5 per cent; OR 0·93, 0·84 to 1·02, P = 0·119) or mortality (1·7 versus 2·5 per cent; OR 0·94, 0·74 to 1·19, P = 0·604). Male sex, higher ASA grade, previous abdominal surgery, open approach and type of procedure were associated with a higher severe complication rate in patients with pT1 colorectal cancer. Conclusion: Elective bowel resection was associated with similar morbidity and mortality rates in patients with pT1 and those with pT2-3 colorectal carcinoma.

Multicentre study of surgical referral and outcomes of patients with benign colorectal lesions.

Background: A multicentre cohort study was performed to analyse the motivations for surgical referral of patients with benign colorectal lesions, and to evaluate the endoscopic and pathological characteristics of these lesions as well as short-term surgical outcomes. Methods: Patients who underwent surgery for a benign colorectal lesion in 15 Dutch hospitals between January 2014 and December 2017 were selected from the pathology registry. Lesions were defined as complex when at least one of the following features was present: size at least 40 mm, difficult location according to the endoscopist, previous failed attempt at resection, or non-lifting sign. Results: A total of 358 patients were included (322 colonic and 36 rectal lesions). The main reasons for surgical referral of lesions in the colon and rectum were large size (33·5 and 47 per cent respectively) and suspicion of invasive growth (31·1 and 58 per cent). Benign lesions could be categorized as complex in 80·6 per cent for colonic and 80 per cent for rectal locations. Surgery consisted of local excision in 5·9 and 64 per cent of colonic and rectal lesions respectively, and complicated postoperative course rates were noted in 11·2 and 3 per cent. In the majority of patients, no attempt was made to resect the lesion endoscopically (77·0 per cent of colonic and 83 per cent of rectal lesions). Conclusion: The vast majority of the benign lesions referred for surgical resection could be classified as complex. Considering the substantial morbidity of surgery for benign colonic lesions, reassessment for endoscopic resection by another advanced endoscopy centre seems to be underused and should be encouraged.

Antecedentes: Se realizó un estudio de cohorte multicéntrico para analizar los motivos de la derivación quirúrgica de pacientes con lesiones colorrectales benignas y evaluar las características endoscópicas y patológicas de estas lesiones, así como los resultados quirúrgicos a corto plazo. Métodos: A partir de un registro anatomopatológico, se seleccionaron los pacientes que se sometieron a cirugía por una lesión colorrectal benigna en 15 hospitales holandeses entre enero de 2014 y diciembre de 2017. Se definió como lesión compleja aquella que presentaba, al menos, una de las siguientes características: tamaño > 40 mm, ubicación difícil según el endoscopista, fracaso previo de la resección o signo de no­elevación. Resultados: Se incluyeron 358 pacientes (322 lesiones de colon y 36 rectales). Las principales razones para la derivación quirúrgica de las lesiones de colon y recto fueron el gran tamaño (34% y 47%) y la sospecha de crecimiento invasivo (31% y 58%). Las lesiones benignas se consideraron complejas en el 81% de los casos del colon y en el 80% del recto. La cirugía consistió en una exéresis local en el 6% y el 64% y se observó una tasa de complicaciones postoperatorias del 11% y el 3% de las lesiones de colon y recto, respectivamente. En la mayoría de los casos, no se intentó la resección endoscópica de la lesión (77% en colon y 83% en recto). Conclusión: La gran mayoría de las lesiones benignas derivadas para la resección quirúrgica podrían clasificarse como complejas. Considerando la notable morbilidad de la cirugía de las lesiones benignas de colon, debería contemplarse y fomentarse la reevaluación de la resección endoscópica en un centro de endoscopia avanzada.

Risk factors for faecal incontinence after rectal cancer treatment.

BACKGROUND: Low anterior resection (LAR) may result in faecal incontinence. This study aimed to identify risk factors for long-term faecal incontinence after total mesorectal excision (TME) with or without preoperative radiotherapy (PRT). METHODS: Between 1996 and 1999, patients with operable rectal cancer were randomized to TME with or without PRT. Eligible patients who underwent LAR were studied retrospectively at 2 years (399 patients) and 5 years (339) after TME. RESULTS: At 5 years after surgery faecal incontinence was reported by 61.5 per cent of patients who had PRT and 38.8 per cent of those who did not (P < 0.001). Excessive blood loss and height of the tumour were associated with long-term faecal incontinence, but only in patients treated with PRT. CONCLUSION: Faecal incontinence is likely to occur after PRT and TME, especially when the perineum is irradiated.

Colorectal cancer screening: Systematic review of screen-related morbidity and mortality.

BACKGROUND: Implementation of mass colorectal cancer screening, using faecal occult blood test or colonoscopy, is recommended by the European Union in order to increase cancer-specific survival by diagnosing disease in an earlier stage. Post-colonoscopy complications have been addressed by previous systematic reviews, but morbidity of colorectal cancer screening on multiple levels has never been evaluated before. AIM: To evaluate potential harm as a result of mass colorectal cancer screening in terms of complications after colonoscopy, morbidity and mortality following surgery, psychological distress and inappropriate use of the screening test. METHODS: A systematic review of all literature on morbidity and mortality attributed to colorectal cancer screening, using faecal occult blood test or colonoscopy, from each databases' inception to August 2016 was performed. A meta-analysis was conducted to examine the pooled incidence of major complications of colonoscopy (major bleedings and perforations). RESULTS: Sixty studies were included. Five out of seven included prospective studies on psychological morbidity reported an association between participation in a colorectal screening program and psychological distress. Serious morbidity from colonoscopy in asymptomatic patients included major bleedings (0.8/1000 procedures, 95% CI 0.18-1.63) and perforations (0.07/1000 procedures, 95% CI 0.006-0.17). CONCLUSIONS: Participation in a colorectal cancer screening program is associated with psychological distress and can cause serious adverse events. Nevertheless, the short duration of psychological impact as well as the low colonoscopy complication rate seems reassuring. Because of limited literature on harms other than perforation and bleeding, future research on this topic is greatly needed to contribute to future screening recommendations.

Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study.

PURPOSE: Preoperative short-term radiotherapy improves local control in patients treated with total mesorectal excision (TME). This study was performed to assess the presence and magnitude of long-term side effects of preoperative 5 x 5 Gy radiotherapy and TME. Also, hospital treatment was recorded for diseases possibly related to late side effects of rectal cancer treatment. PATIENTS AND METHODS: Long-term morbidity was assessed in patients from the prospective randomized TME trial, which investigated the efficacy of 5 x 5 Gy before TME surgery for mobile rectal cancer. Dutch patients without recurrent disease were sent a questionnaire. RESULTS: Results were obtained from 597 patients, with a median follow-up of 5.1 years. Stoma function, urinary function, and hospital treatment rates did not differ significantly between the treatment arms. However, irradiated patients, compared with nonirradiated patients, reported increased rates of fecal incontinence (62% v 38%, respectively; P < .001), pad wearing as a result of incontinence (56% v 33%, respectively; P < .001), anal blood loss (11% v 3%, respectively; P = .004), and mucus loss (27% v 15%, respectively; P = .005). Satisfaction with bowel function was significantly lower and the impact of bowel dysfunction on daily activities was greater in irradiated patients compared with patients who underwent TME alone. CONCLUSION: Although preoperative short-term radiotherapy for rectal cancer results in increased local control, there is more long-term bowel dysfunction in irradiated patients than in patients who undergo TME alone. Rectal cancer patients should be informed on late morbidity of both radiotherapy and TME. Future strategies should be aimed at selecting patients for radiotherapy who are at high risk for local failure.

Prognostic relevance of occult tumour cells in lymph nodes in colorectal cancer.

AIMS: Presently, in Europe the treatment of node-negative colorectal cancer (CRC) patients consists of surgical resection of the primary tumour without adjuvant systemic therapy. However, up to 30% of these patients will develop disease recurrence. These high-risk patients are possibly identified by occult tumour cell (OTC) assessment in lymph nodes. In this paper, studies on the clinical relevance of OTC in lymph nodes are reviewed. METHODS: A literature search was conducted in the National Library of Medicine by using the keywords colonic, rectal, colorectal, neoplasm, adenocarcinoma, cancer, lymph node, polymerase chain reaction, mRNA, immunohistochemistry, micrometastases and isolated tumour cells. Additional articles were identified by cross-referencing from papers retrieved in the initial search. RESULTS: The upstaging percentages through OTC assessment and the prognostic relevance of OTC in lymph nodes vary among studies, which is related to differences in techniques used to detect OTC. CONCLUSIONS: We conclude that OTC examination techniques should be standardized to illuminate whether OTC in lymph nodes can reliably identify high-risk node-negative patients.

Therapeutic strategies in gastric cancer.

Gastric cancer continues to be a major public health problem and is the second most common cause of cancer-related deaths in the world. These statistics led the American Society of Clinical Oncology (ASCO) International Affairs Committee to choose gastric cancer as the topic for the International Symposium held at the 2003 ASCO Annual Meeting. Dr Yoshiaki Ito will discuss the role of RUNX3 in the genesis and progression of human gastric cancer. Dr Pelayo Correa will present a compelling argument on the use of Helicobacter pylori therapy and antioxidants in selected high-risk population as chemoprevention strategies for gastric cancer. The controversy regarding the role of extended lymph node dissection for gastric cancer will be discussed by Dr Cornelis J.H. Van De Velde and Dr Mitsuru Sasako. Dr Van De Velde will present the European surgical approach to gastric cancer, and Dr Sasako will review the Japanese experience. The issues of whether certain patients benefit from more aggressive surgical dissection and the potential risks compared with benefits will also be discussed. Dr John Macdonald will discuss the role of adjuvant chemotherapy and adjuvant chemoradiotherapy in resected gastric cancer, as well as the role of chemotherapy in metastatic gastric cancer.

Surgical quality assurance in rectal cancer treatment: the key to improved outcome.

Surgery is the key to cure for patients with rectal cancer. Surgical techniques are evolving with conventional blunt dissection being increasingly abandoned for the sake of total mesorectal excision (TME), leading to favourable clinical and functional outcome. Surgical quality assurance programmes, involving training of general surgeons to adopt the TME technique, have proven to be feasible and result in improved outcome compared to historical controls. In this overview, developments in rectal cancer treatment are highlighted, the relation of surgeon and/or hospital volume with treatment outcome is discussed, and future directions in optimising rectal cancer treatment are considered.

The feasibility and reliability of sentinel node mapping in colorectal cancer.

AIMS: Sentinel node mapping (SNM) has been introduced in colorectal cancer (CRC) to improve staging by facilitating occult tumour cell (OTC) assessment in lymph nodes that are most likely to be tumour-positive. In this paper, studies on the feasibility and reliability of SNM in CRC are reviewed. METHODS: A literature search was conducted in the National Library of Medicine by using the keywords colonic, rectal, colorectal, neoplasm, adenocarcinoma, cancer and sentinel. Additional articles were identified by cross-referencing from papers retrieved in the initial search. RESULTS: There is a large variation in identification rates and false-negative rates mainly due to the learning curve effect, differences in SNM technique and tumour stage. CONCLUSIONS: We conclude that SNM in CRC is technically feasible. Standardization of SNM procedures is mandatory to resolve the debate on the reliability of sentinel node status for predicting the tumour status of all lymph nodes. Only then can adjuvant treatment of patients upstaged by OTC detection in sentinel nodes be justified.

Quality assurance of surgery in gastric and rectal cancer.

Multimodality and quality controlled treatment result in improved treatment outcome in patients with solid tumours. Quality assurance focuses on identifying and reducing variations in treatment strategy. Treatment outcome is subsequently improved through the introduction of programs that reduce treatment variations to an acceptable level and implement standardised treatment. In chemotherapy and radiotherapy, such programmes have been introduced successfully. In surgery however, there has been little attention for quality assurance so far. Surgery is the mainstay in the treatment of patients with gastric and rectal cancer. In gastric cancer, the extent of surgery is continuously being debated. In Japan, extended lymph node dissection is favoured whereas in the West this type of surgery is not routinely performed with two large European trials concluding that there is no survival benefit from regional lymph node clearance. Post-operative chemoradiation is part of the standard treatment in the United States, although its role in combination with adequate surgery has not been established yet. These global differences in treatment policy clearly relate to the extent and quality of surgical treatment. As for gastric cancer, surgical treatment of rectal cancer patients determines patient's prognosis to a large extent. With the introduction of total mesorectal excision, local control and survival have improved substantially. Most rectal cancer patients receive adjuvant treatment, either pre- or post-operatively. The efficacy of many adjuvant treatment regimens has been investigated in combination with conventional suboptimal surgery. Traditional indications of adjuvant treatment might have to be re-examined, considering the substantial changes in surgical practise. Quality assurance programs enable the introduction of standardised and quality controlled surgery. Promising adjuvant regimens should be investigated in combination with optimal surgery.

Low Maruyama index surgery for gastric cancer: blinded reanalysis of the Dutch D1-D2 trial.

A quantitative estimate of residual nodal disease after gastric cancer surgery, the Maruyama index of unresected disease (MI), proved to be a strong independent predictor of survival in a large U.S. adjuvant chemoradiation study in which surgical undertreatment was frequent. Data from the Dutch D1-D2 Lymphadenectomy Trial permit an opportunity to assess the prognostic value of this variable in a cohort with lower-stage disease treated with minimum D-1 lymphadenectomy and no adjuvant chemoradiation. Blinded to survival, and excluding those cases with missing information, the MI was calculated for 648 of the original 711 patients treated with curative intent. Survival was assessed by log-rank and multivariate Cox regression analysis. All patients have been followed for a minimum of 11 years. Overall Dutch trial findings were not affected by the absence of 63 cases with incomplete data. As expected, the median MI was 26, much lower than in the previous U.S. study. In contrast to the D level, MI < 5 proved to be a strong predictor of survival by both univariate and multivariate analysis. The MI was an independent predictor of both overall survival [P = 0.016; hazard ratio (HR) = 1.45; 95% confidence interval (CI) 1.07-1.95] and relapse risk (P = 0.010; HR = 1.72; 95% CI 1.14-2.60). A strong dose-response reaction with respect to the MI and survival was also observed. We conclude that in this trial low-MI surgery is associated with enhanced survival, whereas outside of certain subgroups routine D2 lymphadenectomy is not. This observation suggests that surgeons might have more of an impact on patient survival by achieving a low-MI operation than a particular D level. A compelling dose-response effect reveals that the MI is a quantitative yardstick for assessing the adequacy of lymphadenectomy in gastric cancer.

Risk factors for anastomotic failure after total mesorectal excision of rectal cancer.

BACKGROUND: Anastomotic leakage is a major complication of rectal cancer surgery. The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision (TME). METHODS: Between 1996 and 1999, patients with operable rectal cancer were randomized to receive short-term radiotherapy followed by TME or to undergo TME alone. Eligible Dutch patients who underwent an anterior resection (924 patients) were studied retrospectively. RESULTS: Symptomatic anastomotic leakage occurred in 107 patients (11.6 per cent). Pelvic drainage and the use of a defunctioning stoma were significantly associated with a lower anastomotic failure rate. A significant correlation between the absence of a stoma and anastomotic dehiscence was observed in both men and women, for both distal and proximal rectal tumours. In patients with anastomotic failure, the presence of pelvic drains and a covering stoma were both related to a lower requirement for surgical reintervention. CONCLUSION: Placement of one or more pelvic drains after TME may limit the consequences of anastomotic failure. The clinical decision to construct a defunctioning stoma is supported by this study.

Managing rectal cancer: the Dutch experience.

One of the major problems in the treatment of rectal cancer has been the inability to achieve local control. Traditional surgery, now outmoded, involves blunt digital dissection and was associated with a high incidence of local recurrence. In an attempt to improve local control and survival, many adjuvant treatment modalities have been investigated. In the context of conventional nonstandardized surgical procedures, pre-operative radiotherapy has been shown to improve local control and overall survival. In recent years treatment outcome has been extensively improved by the introduction of the TME technique first described by Heald. This has resulted in such low recurrence rates and improved survival that the question had to be answered whether pre-operative short-term radiotherapy is still beneficial in TME treated patients. The question was answered in the TME trial set up by the Dutch ColoRectal Cancer Group that randomised between standardized and quality-controlled TME surgery alone and TME surgery preceded by short-term pre-operative radiotherapy. This paper reviews the developments in the treatment of resectable rectal cancer, highlights the results from the Dutch TME trial, and considers future directions in improving outcome.