English translation and cross-cultural validation of the patient-reported outcome measurement-haemorrhoidal impact and satisfaction score (PROM-HISS)

Funding Information: The authors would like to thank the following persons for their contribution to the translation of the PROM-HISS: Ms Sadé Assmann, Ms Isabel Senden, Mr Robert Colin Parker, and Mrs Tamara Boerma. The first author of this study was funded by a grant from The Netherlands Organisation for Health Research and Development (ZonMw 852002023).Peer reviewe

Associations between alcohol consumption and anxiety, depression, and health-related quality of life in colorectal cancer survivors

Purpose  Alcohol consumption is a major risk factor for colorectal cancer (CRC). It is currently poorly understood, however, how alcohol and different alcoholic beverage types are related to psychosocial outcomes in CRC survivors.  Methods  We used data of N = 910 CRC survivors from the pooled EnCoRe and PROCORE cohorts and harmonized them into five time points: at diagnosis and 3, 6, 12, and 24 months post-diagnosis. Generalized estimated equation models were used to examine longitudinal associations of alcohol consumption, including consumption of beer, wine, and liquor, with anxiety, depression, and health-related quality of life (HRQoL), while correcting for sociodemographic, lifestyle, and clinical factors.  Results  Survivors were on average 67 years and 37% was female. In the first 2 years post-diagnosis, survivors who consumed more alcoholic drinks/week reported lower anxiety and depressive symptoms and better HRQoL on all domains and symptom scales. This was the case for moderate and heavy amounts of alcohol and mostly for consuming beer and wine, but not for liquor. Associations were more often significant for men and for younger persons (< 67 years at baseline).  Conclusions  Generally, alcohol consumption was observed to be longitudinally related to less anxiety and depression and better HRQoL in CRC survivors. Implications for Cancer Survivors Although alcohol consumption is generally unfavorable due to increased risk of carcinogenesis and worse prognosis after CRC, it seems to be associated with better psychosocial outcomes in the first 2 years after diagnosis and treatment. More research is needed to gain knowledge about reasons for drinking and causality. Netherlands Trial Registry (www.trialregister.nl, NL6904

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial):Study protocol for a multicentre randomized controlled trial

Background: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. Methods: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, >= 18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. Discussion: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost) effective treatment

Higher Serum Vitamin D Concentrations Are Longitudinally Associated with Better Global Quality of Life and Less Fatigue in Colorectal Cancer Survivors up to 2 Years after Treatment

BACKGROUND: Vitamin D status may be an important determinant of health-related quality of life of colorectal cancer survivors. The current study investigated longitudinal associations between serum 25-hydroxyvitamin D3 (25OHD3) concentrations and quality of life in stage I-III colorectal cancer survivors up to 2 years after treatment. METHODS: Patients with colorectal cancer (n = 261) were included upon diagnosis. Home visits (including blood sampling) were performed at diagnosis and at 6 weeks, 6 months, 1 year, and 2 years after treatment. Serum 25OHD3 concentrations were measured using LC/MS-MS and adjusted for season. Validated questionnaires were used to assess global quality of life and cognitive functioning (EORTC-QLQ-C30), fatigue (EORTC-QLQ-C30 and Checklist Individual Strength, CIS), and depression and anxiety (Hospital Anxiety and Depression Scale). Statistical analyses were performed using linear mixed models and adjusted for sex, age, time since diagnosis, therapy, comorbidities, physical activity, and body mass index. RESULTS: At diagnosis, 45% of patients were vitamin D deficient (<50 nmol/L). After treatment, 25OHD3 concentrations increased on average with 3.1 nmol/L every 6 months. In confounder-adjusted models, 20 nmol/L increments in 25OHD3 were longitudinally associated with increased global quality of life [β 2.9; 95% confidence interval (CI), 1.5-4.3] and reduced fatigue (EORTC-QLQ-C30 subscale: β -3.5; 95% CI, -5.3 to -1.8 and CIS: β -2.8; 95% CI, -4.7 to -0.9). Observed associations were present both within and between individuals over time. CONCLUSIONS: Higher concentrations of 25OHD3 were longitudinally associated with better global quality of life and less fatigue in colorectal cancer survivors. IMPACT: This study suggests that higher 25OHD3 concentrations may be beneficial for colorectal cancer survivors. Future intervention studies are needed to corroborate these findings

Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration

INTRODUCTION The goal of this project was to create an up-to-date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI. METHODS These guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher-level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus. RESULTS These guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients. CONCLUSION These multidisciplinary European guidelines provide an up-to-date comprehensive evidence-based framework with recommendations on the diagnosis and management of adult patients who suffer from FI

The Relation of Lifestyle with Inflammation at the Time of Diagnosis in Patients with Colorectal Cancer

Simple Summary Large intestinal cancer is one of the most common lifestyle-related types of cancer. However, the exact mechanism in the relation between adipose tissue, systemic inflammation and intestinal cancer remains unknown. Furthermore, there are many hypotheses regarding the pathways in which alcohol consumption, smoking, malnutrition and physical inactivity cause low-grade systemic inflammation. In this paper, we discuss the relation of lifestyle with inflammation, in terms of inflammatory markers at the time of diagnosis in intestinal cancer patients. Our findings suggest that an overall unhealthier lifestyle and a higher risk of malnutrition at the time of diagnosis were associated with elevated levels of inflammatory markers. These findings could contribute to formulating lifestyle advice in the future.Abstract Colorectal cancer is one of the most common lifestyle-related types of cancer. The exact pathophysiologic mechanism in the relation between (visceral) adipose tissue, systemic inflammation and colorectal cancer remains unknown. This study aimed to assess the association of lifestyle with markers of systemic inflammation at the time of diagnosis in stage I-III colorectal cancer patients. Patients (n = 298) with stage I-III colorectal cancer from three Dutch hospitals were included at diagnosis. Several lifestyle-related variables (MUST nutritional status score, WCRF/AICR healthy lifestyle score, active smoking, alcohol consumption and BMI) and inflammatory markers (plasma levels of IL-6, IL-8, IL-10, TNF &amp; alpha; and 'high sensitive' hsCRP) were measured at the time of diagnosis. Confounder-adjusted multivariable linear regression models were used to analyse how the lifestyle variables were associated with the inflammatory markers. Statistically significant associations were found between a better WCRF/AICR lifestyle score and lower levels of IL-6 and hsCRP. A medium and high risk of malnutrition according to the MUST score was associated with elevated levels of both IL-8 and hsCRP. An overall unhealthier lifestyle indicated by a lower WCRF/AICR lifestyle score and a higher risk of malnutrition according to the MUST score at the time of diagnosis was associated with elevated levels of inflammatory markers. These findings can contribute to formulating lifestyle advice to improve treatment outcomes and prognosis in patients having CRC in the future

Clinical efficacy of lead revisions during the test phase in sacral neuromodulation for fecal incontinence

Background Success rates of up to 80% have been reported for the SNM screening period in the treatment of fecal incontinence (FI). Some patients who have an unsuccessful index implantation are successfully treated with SNM after a lead revision. There is a lack of studies comparing the outcomes of successful index implantations and successful lead revision. Therefore, the results of index implantations were compared with lead revisions in a single-center cohort. Methods Patients treated with SNM for FI between 2008 and 2016 were retrospectively reviewed. Patients with a successful index implantation were compared with patients who underwent lead revision after SNM screening. Primary outcome was a decrease in episodes of fecal incontinence of >= 50% documented by a 3-week bowel habit diary. Results Two hundred sixty-one patients (232 index group, 29 revision group) were eligible for SNM. Two hundred thirty-one patients (208 index group, 23 revision group) received permanent SNM. Follow-up was 68.8 months for the index group and 62.2 months for the revision group. The number of episodes of FI decreased from 20.6 (SD 19.3) to 3.4 (SD 4.2) in the index group and from 12.6 (SD 5.8) to 2.0 (SD 2.3) in the revision group. This effect was maintained up to 5 and 2 years in the index and revision group, respectively. Adverse events such as loss of efficacy which required surgical intervention did not differ between the two groups. Conclusion Lead revision during the test phase is a valid option in patients with FI treated by SNM who suffer from loss of efficacy of the index electrode