Do beta-blockers reduce negative intrusive thoughts and anxiety in cancer survivors? - An emulated trial.

BACKGROUND: High rates of negative intrusive thoughts have been reported among cancer patients. Prevalent users of beta-blocker therapy have reported lower levels of cancer related intrusive thoughts than non-user. The aim of this study is to investigate if initiation of beta-blocker therapy reduces the prevalence and severity of intrusive thoughts (co-primary endpoints) and the prevalence of anxiety, depressed mood, and low quality of life (secondary endpoints) in cancer survivors. METHODS: Data on patient-reported outcomes from three cohort studies of Swedish patients diagnosed with colon, prostate or rectal cancer were combined with data on beta-blocker prescriptions retrieved from the Swedish Prescribed Drug Register. Two randomized controlled trials were emulated. Trial 1 had follow-up 1 year after diagnosis, trial 2 had follow-up 2 years after diagnosis, baseline in both trials was 12 months before follow-up. Those who initiated beta-blocker therapy between baseline and follow-up was assigned Active group, those who did not was assigned Control group. All endpoints were analysed using Bayesian ordered logistic regression. RESULTS: Trial 1 consisted of Active group, n = 59, and Control group, n = 3936. Trial 2 consisted of Active group, n = 87, and Control group, n = 3132. The majority of participants were men, 83% in trial 1 and 94% in trial 2. The prevalence and severity of intrusive thoughts were lower in the Active group in trial 1, but no significant differences between groups were found in either trial. The prevalence of depressed mood, worse quality of life and periods of anxiety were higher in the Active group in both trials with significant differences for quality of life in trial 1 and anxiety in trial 2. CONCLUSIONS: The emulated trials demonstrated no evidence of a protective effect of beta-blocker therapy against intrusive thoughts. The Active group had reduced quality of life and elevated anxiety compared to the Control group. TRIAL REGISTRATION: The three cohort studies were registered at isrctn.com/clinicaltrials.gov (ISRCTN06393679, NCT02530593 and NCT01477229).

Developing a multivariable prediction model of global health-related quality of life in patients treated for rectal cancer: a prospective study in five countries.

PURPOSE: Rectal cancer and its treatment have a negative impact on health-related quality of life (HRQoL). If risk factors for sustained low HRQoL could be identified early, ideally before the start of treatment, individualised interventions could be identified and implemented to maintain or improve HRQoL. The study aimed to develop a multivariable prediction model for global HRQoL 12 months after rectal cancer treatment. METHODS: Within COLOR II, a randomised, multicentre, international trial of laparoscopic and open surgery for rectal cancer, a sub-study on HRQoL included 385 patients in 12 hospitals and five countries. The HRQoL study was optional for hospitals in the COLOR II trial. EORTC QLQ-C30 and EORTC QLQ-CR38 were analysed preoperatively and at 1 and 12 months postoperatively. In exploratory analyses, correlations between age, sex, fatigue, pain, ASA classification, complications, and symptoms after surgery to HRQoL were studied. Bivariate initial analyses were followed by multivariate regression models. RESULTS: Patient characteristics and clinical factors explained 4-10% of the variation in global HRQoL. The patient-reported outcomes from EORTC QLQ-C30 explained 55-65% of the variation in global HRQoL. The predominant predictors were fatigue and pain, which significantly impacted global HRQoL at all time points measured. CONCLUSION: We found that fatigue and pain were two significant factors associated with posttreatment global HRQoL in patients treated for rectal cancer T1-T3 Nx. Interventions to reduce fatigue and pain could enhance global HRQoL after rectal cancer treatment. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov No. NCT00297791.

Patient reported long-term side effects on bowel function and anal pain in anal cancer survivors - 3- and 6-year results from the Swedish national ANCA study.

AIM: The primary therapeutic option for anal cancer treatment is chemoradiotherapy resulting in 80% survival. The aim of this study was to assess long-term bowel function impairment and anal pain at 3 and 6 years after anal cancer diagnosis, based on a hypothesis of an increase in impairment over time. A secondary aim was to investigate if chemoradiotherapy increased the risk for bowel impairment, compared to radiotherapy alone. METHOD: The ANal CAncer study (ANCA) consists of a national Swedish cohort of patients diagnosed with anal cancer between 2011-2013. Patients within the study were invited to respond to a study-specific questionnaire at 3- and 6-years after diagnosis. Descriptive analyses for the primary endpoint and ordinal logistic regressions for secondary endpoint were performed. RESULTS: A total of 388 patients (84%) were included in the study. At 3 years of follow-up, 264 patients were alive. A total of 195 of these patients (74%) answered a study specific questionnaire, and at 6 years 154 patients (67%). Fifty-seven percent experienced bowel urgency at both 3 and 6 years. There was an increased risk for repeated bowel movement within 1 h (OR 2.44 [95% CI: 1.08-5.61, p = 0.03]) at 3 years in patients who had been treated by chemoradiation compared to radiotherapy alone. CONCLUSIONS: Impairment in bowel function and anal pain after anal cancer treatment should be expected and remains after 6 years. This suggests that long-term follow-up may be necessary in some form after customary follow-up. The addition of chemotherapy increases long-term side effects of bowel function.

Patient reported long-term side effects from treatment on urinary and sexual function in anal cancer survivors - 3- and 6-year results from the Swedish national ANCA study.

AIM: The standard treatment for anal cancer is chemoradiotherapy. Most patients survive anal cancer but remain living with long-term side effects related to the treatment received. The aim of this study was to assess the occurrence of long-term impairment of urinary and sexual function at 3 and 6 years after diagnosis and to investigate the additive effect from chemotherapy in combined chemoradiotherapy on urinary incontinence, compared to radiotherapy alone. METHOD: The ANal CAncer study (ANCA) is based on a national Swedish cohort of patients diagnosed with anal cancer between 2011 and 2013. All identified patients within the study were invited to respond to a study-specific questionnaire at 3 and 6 years. Descriptive analyses for the primary endpoint were performed. To investigate a possible additional effect from chemotherapy logistic regression was used. RESULTS: A total of 388 patients were included in the study. At 3 years 264 patients were alive and invited to respond to an anal cancer specific questionnaire. The 3- and 6 year response rates were 195 (74%) and 155 patients (67%), respectively. The patient reported urinary function impairment at 3 years were urgency (63%), incomplete bladder emptying (47%), and incontinence (46%) and there was an absolute increase of the prevalence of urinary dysfunction in about 10% at 6 years. Three years after diagnosis, 77% reported that intercourse was not part of their sex life; this percentage increased at 6 years to 83%. We found no negative effect of chemotherapy in combined chemoradiotherapy versus radiotherapy alone on patient reported urinary incontinence. CONCLUSION: For anal cancer survivors, urinary function was impaired after 3 years and continued to deteriorate as measured at 6 years after diagnosis. Anal cancer and its treatment negatively affected sexual function for both men and women. This may explain why patients reported that sexual activity and frequency of intercourse was not of importance in their life.

Long-term results of a short-term home-based pre- and postoperative exercise intervention on physical recovery after colorectal cancer surgery (PHYSSURG-C): a randomized clinical trial.

AIM: The aim of this work was to assess the effect of a short-term, home-based exercise intervention before and after colorectal cancer surgery on 12-month physical recovery within a previously reported randomized control trial (RCT). METHOD: PHYSSURG-C is an RCT in six participating hospitals in Sweden. Patients aged ≥20 years planned for elective colorectal cancer surgery were eligible. The intervention consisted of unsupervised moderate-intensity physical activity 2 weeks preoperatively and 4 weeks postoperatively. Usual care was control. The primary outcome measure in PHYSSURG-C was self-assessed physical recovery 4 weeks postoperatively. The predefined long-term follow-up outcomes included: self-assessed physical recovery 12 months postoperatively and reoperations and readmissions 91-365 days postoperatively. The statistical models were adjusted with tumour site (colon or rectum), neoadjuvant therapy (none, radiotherapy or chemo/radiotherapy) and type of surgery (open or laparoscopic). RESULTS: A total of 616 participants were available for the 12-month follow-up. Groups were balanced at baseline regarding demographic and treatment variables. There was no effect from the intervention on self-reported physical recovery [adjusted odds ratio (OR) 0.91, p = 0.60], the risk of reoperation (OR 0.97, p = 0.91) or readmission (OR 0.88, p = 0.58). CONCLUSION: The pre- and postoperative unsupervised moderate-intensity exercise intervention had no effect on long-term physical recovery after elective colorectal cancer surgery. There is still not enough evidence to support clinical guidelines on preoperative exercise to improve outcome after colorectal cancer surgery.

Suicide after colorectal cancer-a national population-based study.

AIM: A cancer diagnosis is often associated with physical as well as emotional distress. Previous studies indicate a higher risk for suicide in patients diagnosed with cancer. The aim of this study was to investigate the prevalence of death by suicide in a national cohort of patients with newly diagnosed colorectal cancer compared with a matched control group to determine if patients with colorectal cancer had an increased incidence of death by suicide. METHOD: This national Swedish cohort was retrieved from the register-based research database CRCBaSe, which includes all patients diagnosed with colorectal cancer between 1997-2006 (rectal) and 2008-2016 (colon) and six controls for each patient matched by age, sex, and county. Cause specific mortality due to suicide was modelled using Cox proportional hazards model and adjusted for known risk factors. RESULTS: The main analysis included patients operated for colorectal cancer, 55 578 patients compared with 307 888 controls. The first year after diagnosis the hazard ratio (HR) for suicide among patients operated for colorectal cancer was 1.86 (CI: 1.18-2.95) compared to controls. Suicide was more common among men than women (HR 2.08; 1.26-3.42 vs. 1.09; 0.32-3.75). A subgroup analysis of the 9198 patients who did not undergo surgery after diagnoses found a seven-fold increase of suicide (HR 7.03; 3.10-15.91). CONCLUSION: Suicide after surgery for colorectal cancer was almost twice as high as in the control group, mainly driven by excess mortality among men. Although the cases were few in the subgroup of nonoperated patients, the considerably higher risk of suicide indicates that more resources might be needed in this group. Evaluation of risk factors for suicide among patients with colorectal cancer should be performed for early identification of individuals at risk.

Survival in relation to time to start of curative treatment of colon cancer: A national register-based observational noninferiority study.

AIM: There are ample discussions regarding the timing of treatment, especially in the era after Covid that caused delay to treatment. The aim of this study was to determine whether a delayed start to curative treatment, within 29-56 days after a diagnosis of colon cancer, was noninferior to starting treatment within 28 days, with regard to all-cause mortality. METHOD: This is a national register-based observational noninferiority study, with a noninferiority margin of hazard ratio (HR) 1.1, including all patients treated with curative intent for colon cancer in Sweden between 2008 and 2016. The primary outcome was all-cause mortality. Secondary outcomes were length of hospital stay, readmissions and reoperations within 1 year after surgery. Exclusion criteria were emergency surgery, disseminated disease at diagnosis, missing diagnosis date and treatment for another cancer 5 years before colon cancer diagnosis. RESULTS: A total of 20 836 individuals were included. A period of 29-56 days from diagnosis to start of curative treatment was noninferior versus starting treatment within 28 days for the primary outcome of all-cause mortality (HR 0.95, 95% CI 0.89-1.00). Starting treatment within 29-56 days was associated with a shorter length of stay (average 9.2 vs. 10 days) but a higher risk of reoperation compared to within 28 days. Post hoc analyses demonstrated that surgical modality was driving survival rather than time to treatment. Overall survival was greater after laparoscopic surgery (HR 0.78, 95% CI 0.69-0.88). CONCLUSION: For patients with colon cancer, a period of up to 56 days from diagnosis to the start of curative treatment did not lead to worse overall survival.

Functional Outcomes of Emergency Surgery for Perforated Diverticulitis, Hinchey Grade III.

BACKGROUND: Laparoscopic lavage as a treatment for perforated diverticulitis, Hinchey III, has been found safe and feasible in randomized trials. A few studies have reported functional outcomes and quality of life as secondary outcomes. This study investigated distress associated with dysfunction of the bowel or stoma, functional outcomes, and quality of life 2-3 years after surgery in a national unselected cohort. METHODS: All patients in Sweden who underwent emergency surgery for perforated diverticulitis with purulent peritonitis (2016-2018) were invited to answer a comprehensive, study-specific questionnaire 2-3 years after the index surgery. RESULTS: Out of 499 potential patients, 226 returned the questionnaire, and 209 were included in the analysis. There was no statistically significant difference between laparoscopic lavage and resection in distress associated with dysfunction of the bowel or stoma (odds ratio [OR], 1.32 [95% CI, 0.91-1.92]; p = 0.015). Bowel dysfunction measured by the LARS score was significantly higher for the lavage group (OR, 1.65 [95% CI, 1.11-2.45]), while stoma was more frequent after resection surgery (40 vs 6%). CONCLUSIONS: Patients experienced long-term distress from bodily dysfunction after emergency surgery for perforated diverticulitis regardless of the technique used. Regular follow-up could benefit these patients. TRIAL REGISTRATION: The project was registered at ClinicalTrials.gov on 2017-11-06. Identifier: NCT03332550. Acronym: LapLav.

Sick leave and predictive factors for sick leave at 12 months after breast cancer surgery in the randomized controlled physical activity trial (PhysSURG-B).

OBJECTIVE: To evaluate sick leave 12 months after breast cancer surgery, to analyze the effect of adjuvant chemotherapy and to identify predictive factors for sick leave, based on a randomized controlled trial of a non-supervised physical activity intervention (PhysSURG-B). METHODS: Sick leave days (for patients age 18-67) were collected from the Swedish Social Insurance Agency, and compared between the intervention and control arm in the trial. A random forest model was used to analyze predictive factors for sick leave, including baseline patient and tumor characteristics as well as patient-reported outcomes measuring quality of life, personality traits, pain, anxiety and depression. RESULTS: A total of 203 patients were analyzed, and when comparing intervention to control, there was no differences in sick leave days (117 vs 55 days, odds ratio 1.21; 95% CI 0.75-1.96). Adjuvant chemotherapy significantly increased days of sick leave (323 vs 42 days, odds ratio 17.3; 95% CI 9.15-34.2). Factors predicting prolonged sick leave were adjuvant chemotherapy, young age, previous mental health problems and low quality of life (measured as FACT-B score) at baseline. CONCLUSION: A non-supervised physical activity intervention had no effect on sick leave 12 months after surgery. Significantly longer sick leave was seen in patients treated by adjuvant chemotherapy. Factors predicting prolonged sick leave can be recognized at baseline and utilized when designing future interventions.

Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence.

OBJECTIVE: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. SUMMARY OF BACKGROUND DATA: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. METHODS: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. RESULTS: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. CONCLUSION: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

Effect of Short-term Homebased Pre- and Postoperative Exercise on Recovery After Colorectal Cancer Surgery (PHYSSURG-C): A Randomized Clinical Trial.

OBJECTIVE: To determine the effect of a short-term, unsupervised exercise intervention before and after colorectal cancer surgery on self-assessed physical recovery. SUMMARY OF BACKGROUND DATA: Preoperative exercise interventions could help improve recovery after colorectal cancer surgery and is currently recommended. METHODS: A randomized, parallel, open-label trial in six university or regional hospitals in Sweden. Inclusion criteria were age ≥20 years and planned elective colorectal cancer surgery. Participants were randomized to either a physical activity intervention with aerobic activity and inspiratory muscle training 2 weeks pre- and 4 weeks postoperatively or usual care. The primary outcome measure was self-assessed physical recovery 4 weeks postoperatively. Analyses were performed according to intention to treat. Outcome assessors were masked regarding the intervention while both participants and physiotherapists were informed due to the nature of the intervention. RESULTS: Between January 22, 2015, and May 28, 2020, 761 participants were recruited and assigned to either intervention (I) (n = 379) or control (C) (n = 382). After exclusions 668 participants (I = 317, C = 351) were included in the primary analysis. There was no effect from the intervention on the primary outcome measure (adjusted odds ratio 0.84, 95% confidence interval 0.62-1.15) with 13% and 15% of participants feeling fully physically recovered in I and C, respectively. There were no reported adverse events. CONCLUSIONS: There was no effect from a physical activity intervention before and after colorectal cancer surgery on short-term self-assessed physical recovery. The results from this study call for reconsiderations regarding current recommendations for preoperative physical activity interventions.

Symptoms and diagnosis of local recurrence after rectal cancer treatment.

AIM: The prognosis for local recurrence after rectal cancer treatment is poor. A minority of patients are eligible for surgery with curative intent, which could possibly be improved by earlier detection. The aim of this study was to determine symptoms at presentation and how local recurrence was diagnosed, and to identify alarm symptoms for local recurrence as opposed to symptoms found among patients after surgery for rectal cancer in general. METHODS: In a population-based retrospective cohort (cohort A), all patients who had undergone resection surgery for rectal cancer in the region of Västra Götaland, Sweden, diagnosed 2010-2014, were identified through the Swedish ColoRectal Cancer Registry. After a follow-up period of at least five years, medical records were reviewed to identify patients diagnosed with local recurrence. Data on symptoms, diagnostic procedures and treatment of local recurrence were retrieved. A prospective cohort of patients who had undergone surgery for rectal cancer without local recurrence (the QoLiRECT-study, cohort B) was used for comparison regarding symptoms at two years after treatment. RESULTS: Cohort A consisted of 1208 patients, out of whom 78 (6%) were diagnosed with local recurrence. Forty-six patients were diagnosed between scheduled follow-up visits. Fifty-eight patients were symptomatic at the time of diagnosis, and the most common symptoms were pain, bleeding and urogenital symptoms. Pain was more common in patients with local recurrence when comparing cohort A with cohort B. CONCLUSION: A majority of patients with local recurrence were diagnosed outside of the scheduled follow-up. Most of the patients were symptomatic at diagnosis. Symptoms were common in patients after rectal cancer surgery in general, however pain was more common in patients with local recurrence and could represent an alarm symptom.

Long-term survival after treatment for primary anal cancer- results from the Swedish national ANCA cohort study.

BACKGROUND: Squamous cell carcinoma of the anus is increasing in incidence but remains a rare disease with good 3- and 5-year recurrence free and overall survival rates of 63%-86%. The treatment includes chemoradiotherapy, mainly with 5-fluoruracil (5FU) and mitomycin. The aim of this study was to describe long-term (up to 9 years after treatment) oncological outcome and the types of treatments given, in a Swedish national cohort of patients diagnosed with anal cancer between 2011 and 2013. METHOD: Patients were identified in the Swedish Cancer Registry. Patients still alive were contacted and asked for consent. Clinical data were retrieved from National Patient Register at the Swedish National Board of Health and Welfare and from medical records. Unadjusted and adjusted analyses were performed for overall survival. RESULTS: Three hundred and eighty-eight patients were included in the study of which 338 patients (87%) received treatment with a curative intent. Follow up was 85 months (0-113 months) for patients treated with curative intent (information missing in one patient) 7.5 months (0-55) for patients with treated with a palliative intent. Curative treatment varied and consisted of both chemoradiotherapy and radiotherapy (46-64 Gy) alone. 5-FU, mitomycin and cisplatin were the most used chemotherapy agents. Five-year overall survival for patients treated with curative intent was 73%. In an adjusted analysis 5-FU and mitomycin is associated with a lower mortality than 5-FU and cisplatin but the association was weaker (HR 1.61 (95% CI: 0.904; 2.85) than in the unadjusted analysis. CONCLUSIONS: In this national cohort overall five-year survival was 73% for patients treated with curative intent. As reported by others our results indicate that 5-FU and mitomycin C should be the preferred chemotherapy in treatment for cure.

Intraoperative adverse events as a risk factor for local recurrence of rectal cancer after resection surgery.

AIM: Failure to achieve a radical resection as well as intraoperative rectal perforation are important risk factors for local recurrence after rectal cancer surgery, but the importance of other intraoperative adverse events for the prognosis is unknown. The aim of this study was to assess the occurrence of intraoperative adverse events during rectal cancer surgery, and to determine whether these were associated with an increased risk of local recurrence. METHODS: A retrospective population-based cohort study was undertaken, including all patients in Region Västra Götaland, Sweden, who had undergone primary resection surgery for rectal cancer diagnosed between 2010 and 2014, registered in the Swedish Colorectal Cancer Registry. Data were retrieved from the registry and through review of the medical records. RESULTS: In total, 1208 patients were included in the study of whom 78 (6%) developed local recurrence during the follow-up period of at least 5 years. Intraoperative adverse events were common and occurred in 62/78 (79%) of patients with local recurrence compared to 604/1130 (53%) of patients without local recurrence. In multivariate analysis intraoperative adverse events were found to be an independent risk factor for local recurrence of rectal cancer, as were nonradical resection, a high pathological T stage, the presence of lymph node metastases, type of surgery and refraining from rectal washout during anterior resection and Hartmann's procedure. CONCLUSIONS: Intraoperative adverse events were found to be an independent risk factor for local recurrence of rectal cancer and could possibly be used together with other known risk factors to select patients for intensified postoperative surveillance.

Patient-reported QoL in anal cancer survivors 3 and 6 years after treatment-results from the Swedish national ANCA study.

PURPOSE: The impact of anal cancer treatment for the patients is best evaluated by the patients themselves. The purpose of this study was to investigate quality of life (QoL) in patients with anal cancer at 3 and 6 years after treatment. METHODS: A Swedish national cross-sectional prospective cohort study with patients diagnosed with anal cancer between 2011 and 2013. Patients were invited to respond to a QoL questionnaire at 3 and 6 years, with focus on bowel, urinary and sexual function, social and mental function, co-morbidity, lifestyle, daily activities, personal characteristics, and perceived QoL. It also contained questions on the severity of the symptoms regarding occurrence, frequency, and duration and the level of "bother" experienced related to functional symptoms. QoL and prevalence of bother with urinary, sexual, bowel dysfunction, and anal pain were described. The prevalence of impaired QoL was compared with a healthy reference population. The association between QoL and experiencing bother was quantified by regression models. RESULTS: From an original cohort of 464 patients with anal cancer, 264 (57%) were alive and contacted at 3 years and 230 (50%) at 6 years. One hundred ninety-five (74%) patients responded to the 3-year and 152 (66%) to the 6-year questionnaire. Sixty percent reported low QoL at both 3 and 6 years. Impaired QoL was more prevalent among patients with major bother due to bowel dysfunction (at 3 years RR 1.42, 95% CI (1.06-1.9) p-value 0.020, at 6 years RR 1.52, 95% CI (1.03-2.24) p-value 0.034) and urinary dysfunction (at 6 years RR 1.44, 95% CI (1.08-1.91) p-value 0.013). There was a tendency to a positive relationship between the number of bodily functions causing bother and risk for impaired QoL. CONCLUSION: Patients treated for anal cancer reported bother regarding several bodily functions as well as poor QoL both at 3 and 6 years without much improvement. Bother was also associated with low QoL indicating that function-related bother should be addressed.

Preoperative Group Consultation Prior to Surgery for Colorectal Cancer-an Explorative Study of a New Patient Education Method.

Patients with colorectal cancer may lack information about the disease and treatment. In 2017, a group consultation before start of surgery was introduced at a university hospital in western Sweden to inform about the disease, treatment, and ongoing scientific studies. The primary aim of this study was to explore the experience of the patients attending the group consultation. Based on semi-structured interviews with patients with colorectal cancer, a questionnaire was constructed and administered to patients, both those attending and those not attending the group consultation. In total, 124 patients were included and the response rate was 86%. A majority of patients attending the group consultation would recommend it to someone else with the same illness. Of the patients attending the group consultation, 81% (30/37) patients agreed, fully or partially, that attending the group consultation had increased their sense of control and 89% (33/37) that the information they received at the group consultation increased their feeling of participation in the treatment. Preoperative group consultation is a feasible modality for informing and discussing the upcoming treatment for colorectal cancer with the patients, and the patients who attended the group setting appreciated it. Attending the group consultation increased the patients' feeling of active participation in their treatment and their sense of control, which could possibly both improve their experience of their illness and facilitate recovery. CLINICALTRIALS.GOV IDENTIFIER: NCT03888313.

Methods of Colostomy Construction: No Effect on Parastomal Hernia Rate: Results from Stoma-const-A Randomized Controlled Trial.

OBJECTIVE: The primary objective of this trial was to compare the parastomal hernia rates 1 year after the construction of an end colostomy by 3 surgical techniques: cruciate incision, circular incision in the fascia and using prophylactic mesh. Secondary objectives were evaluation of postoperative complications, readmissions/reoperations, and risk factors for parastomal hernia. SUMMARY OF BACKGROUND DATA: Colostomy construction techniques have been explored with the aim to improve function and reduce stoma complications, but parastomal herniation is frequent with an incidence of approximately 50%. METHODS: A randomized, multicenter trial was performed in 3 hospitals in Sweden and Denmark; all patients scheduled to receive an end colostomy were asked to participate. Parastomal hernia within 12 months was determined by computed tomography of the abdomen in prone position and by clinical assessment. Complications, readmissions, reoperations, and risk factors were also assessed. RESULTS: Two hundred nine patients were randomized to 1 of the 3 arms of the study. Patient demographics were similar in all 3 groups. Assessment of parastomal hernia was possible in 185 patients. The risk ratio (95% confidence interval) for parastomal hernia was 1.25 (0.83; 1.88), and 1.22 (0.81; 1.84) between cruciate versus circular and cruciate versus mesh groups, respectively. There were no statistically significant differences between the groups with regard to parastomal hernia rate. Age and body mass index were found to be associated with development of a parastomal hernia. CONCLUSION: We found no significant differences in the rates of parastomal hernia within 12 months of index surgery between the 3 surgical techniques of colostomy construction.

Surgeon heterogeneity significantly affects functional and oncological outcomes after radical prostatectomy in the Swedish LAPPRO trial.

OBJECTIVES: To evaluate how surgeon heterogeneity - the variation in outcomes between individual surgeons - influences functional and oncological outcomes after robot-assisted laparoscopic prostatectomy (RALP) and retropubic radical prostatectomy (RRP), and to assess whether surgeon heterogeneity affects the comparison between RALP and RRP. PATIENTS AND METHODS: Laparoscopic Prostatectomy Robot Open (LAPPRO) is a prospective, controlled, non-randomized trial performed at 14 Swedish centres with 68 operating surgeons. A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011. The endpoints were urinary incontinence, erectile dysfunction (ED) and recurrence at 24 months after surgery. Logistic regression models were built to evaluate surgeon heterogeneity and, secondarily, surgeon-specific factors were added to the models to investigate their influence on heterogeneity and the comparison between RALP and RRP. RESULTS: Among surgeons who performed at least 20 surgeries during the study period (n=25), we observed statistically significant heterogeneity for incontinence (P = 0.001), ED (P < 0.001) and rate of recurrent disease (P < 0.001). The significant heterogeneity remained when analysing only experienced surgeons with a stated experience of at least 250 radical prostatectomies (n=12). Among all participating surgeons (n=68), differences in surgeon volume explained 42% of the observed heterogeneity for incontinence (P = 0.003), 11% for ED (P = 0.03) and 19% for recurrence (P = 0.01). Taking surgeon volume into account when comparing RALP and RRP had a significant impact on the results. The effect was greatest for functional outcomes, and the additional adjustments for the surgeons' previous experience changed whether the difference between techniques was statistically significant or not. The surgeons' annual volume had the greatest effect on the recurrence rate. CONCLUSIONS: There was a large degree of heterogeneity among surgeons regarding both functional and oncological outcomes and this had a significant impact on the results when comparing RALP and RRP. Some of the observed heterogeneity was explained by differences in surgeon volume. Efforts to decrease heterogeneity are warranted and variation among surgeons must be accounted for when conducting comparative analyses between surgical techniques.

Urinary continence recovery and oncological outcomes after surgery for prostate cancer analysed by risk category: results from the LAParoscopic prostatectomy robot and open trial.

PURPOSE: To evaluate urinary continence (UC) recovery and oncological outcomes in different risk-groups after robot-assisted radical prostatectomy (RALP) and open retropubic radical prostatectomy (RRP). PATIENTS AND METHODS: We analysed 2650 men with prostate cancer from seven open (n = 805) and seven robotic (n = 1845) Swedish centres between 2008 and 2011 in a prospective non-randomised trial, LAPPRO. UC recovery was defined as change of pads less than once in 24 h. Information was collected through validated questionnaires. Rate of positive surgical margins (PSM) and biochemical recurrence (BCR), defined as prostate-specific antigen (PSA) > 0.25 mg/ml, were recorded. We stratified patients into two risk groups (low-intermediate and high risk) based on the D'Amico risk classification system. RESULT: Among men with high-risk prostate cancer, we found significantly higher rates of UC recovery up to 24 months after RRP compared to RALP (66.1% vs 60.5%) RR 0.85 (CI 95% 0.73-0.99) while PSM was more frequent after RRP compared to RALP (46.8% vs 23.5%) RR 1.56 (CI 95% 1.10-2.21). In the same group no significant difference was seen in BCR. Overall, however, BCR was significantly more common after RRP compared to RALP at 24 months (9.8% vs 6.6%) RR 1.43 (Cl 95% 1.08-1.89). The limitations of this study are its non-randomized design and the relatively short time of follow-up. CONCLUSIONS: Our study indicates that men with high-risk tumour operated with open surgery had better urinary continence recovery but with a higher risk of PSM than after robotic-assisted laparoscopic surgery. No significant difference was seen in biochemical recurrence.  TRIAL REGISTRATION: ISRCTN06393679.

Collaboration in colorectal surgical research.

Surgical research has been under-powered, under-funded and under-delivered for decades. A solution may be to form large research collaborations and thereby enable implementation of successful interventional trials as well as robust international observational studies with thousands of patients. There are many such research collaborations in colorectal surgery, and in this paper we have highlighted the experiences from the West Midlands Research Collaborative (WMRC), the Scandinavian Surgical Outcomes Research Group (SSORG) and the European Society of Coloproctology. With active research networks, it is possible to deliver large, high-quality studies and provide high-level evidence for solving important clinical questions in an efficient and timely manner.