Bowel dysfunction following pelvic organ cancer: a prospective study on the treatment effect in nurse-led late sequelae clinics.

BACKGROUND: Bowel dysfunction following treatment of pelvic organ cancer is prevalent and impacts the quality of life (QoL). The present study aimed to evaluate the feasibility and effects of treating bowel dysfunction in two nurse-led late sequelae clinics. MATERIAL AND METHODS: Treatment effects were monitored prospectively by patient-reported outcome measures collected at baseline and discharge. Change in bowel function was evaluated by 15 bowel symptoms, the St. Mark's Incontinence Score, the Patients Assessment of Constipation-Symptoms (PAC-SYM) score and self-rated bowel function. QoL was evaluated by the EuroQol 5-dimension 5-level (EQ-5D-5L) utility score and by measuring the impact of bowel function on QoL. RESULTS: From June 2018 to December 2021, 380 cancer survivors (46% rectal, 15% gynaecological, 13% anal, 12% colon, 12% prostate, and 2% other cancers) completed a baseline questionnaire and started treatment for bowel dysfunction. At referral, 96% of patients were multisymptomatic. The most frequent symptoms were faecal urgency (95%), fragmented defaecation (93%), emptying difficulties (92%), flatus/faecal incontinence (flatus 89%, liquid 59%, solid 33%), and obstructed defaecation (79%). In total, 169 patients were discharged from the clinics in the follow-up period. At discharge, 69% received conservative treatment only and 24% also received transanal irrigation; 4% were surgically treated; 3% discontinued treatment. Improvements were seen in all 15 bowel symptoms (p < 0.001), the mean St. Mark's Incontinence Score (12.0 to 9.9, p < 0.001), the mean PAC-SYM score (1.04 to 0.84, p < 0.001) and the mean EQ-5D-5L utility score (0.78 to 0.84, p < 0.001). Self-rated bowel function improved in 56% (p < 0.001) of cases and the impact of bowel function on QoL improved in 46% (p < 0.001). CONCLUSION: Treatment of bowel dysfunction in nurse-led late sequelae clinics is feasible and significantly improved bowel function and QoL.

Prospective evaluation of bowel function and quality of life after colon cancer surgery - is it time for routine screening for late sequelae?

AIM: Bowel dysfunction after colon cancer (CC) surgery is widely neglected in current follow up programmes. This study explored changes in bowel function and quality of life (QoL) from three (3 m) to twelve months (12 m) after surgery in CC patients undergoing right- or left-sided colon resection (RightSCR/LeftSCR) and investigated differences between the two groups 12 m after surgery. METHOD: CC patients undergoing surgical resection in 2018-2020 at five surgical departments were included in this population-based prospective cohort study. Included patients completed electronic surveys consisting of a collection of validated scores 3 m and 12 m after surgery. RESULTS: A total of 708 CC patients (423 RightSCR, 285 LeftSCR) were included. In RightSCR, no improvement was observed from 3 m to 12 m in most scores/items, on the contrary, symptom worsening in flatus- and faecal incontinence and urgency was observed (p < 0.05). Also, the proportion of patients rating their bowel function as very good/good decreased (p < 0.05) in this group. In LeftSCR improvement was found in flatus and faecal incontinence, urgency and night-time defaecation (p < 0.02), while no improvement was observed in the remaining scores/items. At 12 m, higher proportions of RightSCR than LeftSCR reported loose stools, incontinence and urgency (all p < 0.001), whereas LeftSCR more often reported hard stools and flatus incontinence (p < 0.05). Among all CC patients 18.3% reported bowel-related impairment of QoL at 12 m with no differences between the two groups. CONCLUSION: From 3 m to 12 m no significant change was observed in the majority of bowel function and QoL scores/items, however, some symptoms worsened in RightSCR, while a few improved in LeftSCR. Bowel dysfunction and impaired QoL were still common in both groups at 12 m, although the symptom pattern differed between the groups. These findings call for a systematic screening for bowel dysfunction to ensure early treatment of symptoms.

Chronic pain after colon cancer surgery: Translation and validation of a scoring system.

OBJECTIVE: The aim of this study was to translate and validate the chronic pain score (CP score) in a cohort of colon cancer patients. Chronic pain following colon cancer surgery is still poorly understood, in particular the lack of a validated tool for measuring chronic pain is a major issue as such an instrument is critical for evaluating the incidence and risk factors. The CP score was created using data from Danish rectal cancer patients. METHODS: Danish colorectal cancer survivors diagnosed between 2001 and 2014 completed the CP score and two quality of life (QoL) measures. Clinical data were obtained from a national database. Convergent validity was investigated by testing the association of the CP score with a single ad hoc QoL item and the EORTC QLQ-C30, and discriminative validity was tested as the score's ability to differentiate between gender and age groups. Sensitivity and specificity were evaluated by determining the ability of the score to identify patients with a major impact of pain on QoL. RESULTS: Responses from 7127 colon cancer were included. Convergent validity was confirmed, as the score was associated with both QoL measures (p < 0.001). Moreover, the score could differentiate between males/females and older/younger patients (p < 0.001, respectively), reflecting high discriminative validity. Finally, the score was able to identify patients with a major impact on QoL, with a sensitivity of 87% and specificity of 82%. CONCLUSION: The CP score is a valid tool for measuring chronic pain after colon cancer surgery and should be used to homogenize outcomes in future studies.

Validation of the Turkish translation of the low anterior resection syndrome (LARS) score.

BACKGROUND: Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to assess this syndrome and its impact on the quality of life in Danish patients. Recently versions in English and many other languages have been validated. The aim of this study was to validate the Turkish translation of the LARS score in patients who have undergone treatment for rectal cancer. METHODS: Rectal cancer patients who underwent low anterior resection in May 2000- May 2018 in three Turkish centers received the LARS score questionnaire, the European Organisation for Research and Treatment Of Cancer Core Quality of Life questionnaire [Ed.11] (EORTC QLQ-C30), and a single ad hoc quality of life question. The test-retest reliability of the LARS score was evaluated by asking a randomly selected subgroup of patients to repeat the assessment of the LARS score 2 to 4 weeks after their initial response. RESULTS: A total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses (129 males, 93 females, median age 64 years [range:24-87 years, IQR = 14]) There was a strong association between the LARS score and quality of life (p < 0.01) and the test-retest reliability was high. The intraclass correlation coefficient was 0.78 (95% CI 0.73-0.83) for the whole study group and 0.79 (95% CI 0.68-0.87) for the subgroup, indicating strong reliability. CONCLUSIONS: The Turkish translation of the LARS score has psychometric properties comparable with previously published results in similar studies. The Turkish version of the LARS score can be considered a valid and reliable tool for measuring LARS in Turkish rectal cancer patients. CLINICAL TRIAL REGISTRATION: NCT05289531.

Diet and bowel symptoms among colon cancer survivors.

BACKGROUND: Survival from colon cancer (CC) has improved considerably over the last decades, yet many survivors suffer from late sequelae from treatment. Typical symptoms of bowel dysfunction after treatment of CC are diarrhea, urge for defecation, fecal incontinence, bloating and constipation. Most CC survivors make dietary changes to alleviate bowel symptoms. We aimed to describe the self-perceived effects of diet on bowel function among CC survivors and the level of dietary information given. MATERIALS AND METHODS: In this cross-sectional study, CC patients from four surgical departments in Denmark completed surveys regarding the effects of diet on their bowel function and whether they had previously received dietary advice. Data concerning sociodemographic characteristics and the surgical procedure (right-sided or left-sided hemicolectomy) were collected from the Danish Colorectal Cancer Group database. Forty-four healthcare professionals specialized in CC completed a questionnaire on how they advise CC. Descriptive statistics were applied. RESULTS: Among 1544 patients invited, 1239 (80.4%) responded, and 844 met the inclusion criteria (53% males, median age 72.6 years, median time since surgery 742 days). Among these, 267 (32%) reported that food affected bowel function. Fat was perceived to have a negative effect in 193 (25%), spices in 149 (19%), sweets in 101 (13%) and meat in 99 (13%). There was no association between tumor site and food categories affecting bowel function (p = 0.078). Most healthcare professionals (93%) stated that their unit gave advice about diet, but only 24% of patients remembered such information. CONCLUSION: One-third of CC survivors perceive that food items, especially fat and spices have a negative impact on their bowel function. We found a major discrepancy between healthcare professionals reporting that they provide advice and the proportion of patients remembering this. There is an unmet need for further recognition of the role of diet in CC rehabilitation and for intervention studies of treatment principles.

Patient reported outcome measures assessing quality of life in patients with an intestinal stoma: A systematic review.

AIM: Living with a stoma can greatly influence quality of life. The purpose of this systematic review was to identify all patient reported outcome measures (PROMs) assessing health related quality of life (HRQoL) or similar constructs related to an intestinal stoma and to evaluate their level of validation. METHODS: The study was reported in line with PRISMA guidelines. The protocol was registered in PROSPERO prior to the study. Eligible studies were any study investigating psychometric properties of a stoma-specific PROM. The databases MedLine, Embase, CINAHL and Cochrane Libraries were searched for eligible studies. Studies were screened on title and abstract, then full-text for eligibility. Data extraction on the study populations, PROM characteristics, psychometric properties as well as quality assessment using the COSMIN Risk of Bias checklist was performed. RESULTS: In total, 40 studies were included concerning the development and/or validation of 21 PROMs. For most PROMs, few psychometric properties were assessed. In general, quality of content validity was poor, quality of construct validity and reliability was good. Assessment of responsiveness was lacking. CONCLUSION: This systematic review offers an overview of existing PROMs measuring stoma-related HRQoL and their psychometric properties. A large number of PROMs exist and their measures overlap considerably. The PROMs generally have a low level of validation, emphasizing the need for future studies to further validate existing PROMs, rather than developing new ones.

Functional Outcomes and Quality of Life after Redo Anastomosis in Patients With Rectal Cancer: An International Multicenter Comparative Cohort Study.

BACKGROUND: Redo anastomosis can be considered in selected patients with persistent leakage, stenosis, or local recurrence. It is technically challenging, and little is known about the functional outcomes after this seldomly performed type of surgery. OBJECTIVE: The aim of this study was to compare functional outcomes and the quality of life between redo anastomosis and primary successful anastomosis following total mesorectal excision for rectal cancer. DESIGN: This study was designed as an international multicenter comparative cohort study. SETTINGS: The study was conducted in 3 tertiary referral centers in the Netherlands, Belgium, and France. PATIENTS: Patients undergoing redo anastomosis were compared with patients with a primary successful anastomosis after total mesorectal excision for rectal cancer. MAIN OUTCOME MEASURES: Low anterior resection syndrome score, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30, and EORTC QLQ-CR29 questionnaires were used to assess outcomes. RESULTS: In total, 170 patients were included; 52 underwent redo anastomosis and 118 were controls. Major low anterior resection syndrome occurred in 73% after redo anastomosis compared with 68% following primary successful anastomosis (p = 0.52). The redo group had worse EORTC QLQ-CR29 mean scores for fecal incontinence (p = 0.03) and flatulence (p = 0.008). There were no differences in urinary (p = 0.48) or sexual dysfunction, either in men (p = 0.83) or in women (p = 0.76). Significantly worse scores in the redo group were found for global health (p = 0.002), role (p = 0.049) and social function (p = 0.006), body image (p = 0.03), and anxiety (p = 0.02). LIMITATIONS: This study is limited by the possible response bias. CONCLUSIONS: Redo anastomosis is associated with significantly worse quality of life compared with primary successful anastomosis. However, major low anterior resection syndrome was comparable between groups and should not be a reason to preclude restoration of bowel continuity in highly motivated patients. See Video Abstract at http://links.lww.com/DCR/B565. RESULTADOS FUNCIONALES Y DE CALIDAD DE VIDA POSTERIOR A LA RECONSTRUCCIN DE LA ANASTOMOSIS EN PACIENTES CON CNCER DE RECTO ESTUDIO INTERNACIONAL MULTICNTRICO DE COHORTE COMPARATIVO: ANTECEDENTES:Se puede considerar reconstruir la anastomosis en pacientes seleccionados con fuga persistente, estenosis o recidiva local. Esto es técnicamente desafiante y poco se sabe sobre los resultados funcionales después de este tipo de cirugía que rara vez se realiza.OBJETIVO:El objetivo de este estudio fue comparar resultados funcionales y la calidad de vida entre reconstrucción de la anastomosis y la anastomosis primaria exitosa posterior de la escisión total de mesorrecto (TME) por cáncer de recto.DISEÑO:Este estudio fue diseñado como un estudio internacional multicéntrico de cohorte comparativo.ENTORNO CLINICO:El estudio se llevó a cabo en tres centros de referencia terciarios en Holanda, Bélgica y Francia.PACIENTES:Los pacientes sometidos a reconstrucción de anastomosis fueron comparados con pacientes con anastomosis primaria exitosa después de TME por cáncer de recto.PRINCIPALES MEDIDAS DE VALORACION:Los cuestionarios; Escala de Síndrome de Resección Anterior Baja (LARS), EORTC QLQ-C30, y QLQ-CR29, fueron utilizados para evaluar los resultados.RESULTADOS:En total, se incluyeron 170 pacientes; 52 reconstrucción de anastomosis y 118 controles. LARS ocurrió en el 73% posterior a la reconstrucción de la anastomosis en comparación con el 68% posterior a la anastomosis primaria exitosa (p = 0,52). El grupo de reconstrucción tuvo peores puntuaciones medias de EORTC QLQ-CR29 para incontinencia fecal (p = 0,03) y flatulencia (p = 0,008). No hubo diferencias en disfunción urinaria (p = 0,48) o sexual, ni en hombres (p = 0,83) ni en mujeres (p = 0,76). Se encontraron puntuaciones significativamente peores en el grupo de reconstrucción para salud global (p = 0,002), desempeño (p = 0,049) y función social (p = 0,006), imagen corporal (p = 0,03) y ansiedad (p = 0,02).LIMITACIONES:La limitación de este estudio es el posible sesgo de respuesta.CONCLUSIONES:La reconstrucción de la anastomosis se asocia con una calidad de vida significativamente peor en comparación con los pacientes con anastomosis primaria exitosa. Sin embargo, LARS fue comparable entre los grupos y no debería ser una razón para impedir la restauración de la continuidad intestinal en pacientes muy motivados. Consulte Video Resumen en http://links.lww.com/DCR/B565.

Patient-led follow-up reduces outpatient doctor visits and improves patient satisfaction. One-year analysis of secondary outcomes in the randomised trial Follow-Up after Rectal CAncer (FURCA).

BACKGROUND: FURCA (Follow-Up after Rectal Cancer) is a multi-centre randomised trial comparing patient-led follow-up with standard outpatient follow-up. This paper reports one-year follow-up data from the FURCA trial on selected secondary outcomes including type and number of contacts, patient-reported involvement and satisfaction with health care services during follow-up. MATERIAL AND METHODS: Patients with rectal cancer (stage < IV) from four Danish surgical centres were randomised (1:1) into intervention (education and self-referral to project nurse) or standard follow-up (routine clinical doctor visits). The present analysis involved data on hospital contacts during the first year after surgery, patient involvement and satisfaction measured at one year, and baseline patient-reported and clinical variables. RESULTS: Of 512 eligible patients, 168 were allocated to patient-led follow-up (intervention) and 168 to standard follow-up (control). The total number of hospital contacts in the intervention arm did not differ significantly from the number of contacts in the control arm (p = 0.44). More patients had ≥15 contacts in the intervention arm than in the control arm (p = 0.004). The total number of outpatient doctor visits was significantly lower in the intervention arm (p < 0.001). Patients in both arms rated involvement and satisfaction high; yet patients in the intervention arm scored significantly higher on two of six items regarding involvement and all five items regarding satisfaction. Of the 168 patients in the intervention arm, 43% made direct contact (self-referral) to the project nurse, and 14 of these patients (8%) had ≥4 contacts. The primary reason for self-referral was bowel dysfunction. DISCUSSION: The findings indicate the value of a patient-led follow-up program in terms of direct access and more individually tailored intervention based on patients' needs, with most tasks being managed by nurses. Patient-led follow-up came with improved patient-perceived involvement and satisfaction; thus, it was both acceptable and favourable for the patients.

Systematic screening for late sequelae after colorectal cancer-a feasibility study.

AIM: The aim of this study was to test the feasibility of a new method for systematic screening for late sequelae (LS) following colorectal cancer treatment. METHOD: Patients with colorectal cancer from five Danish hospitals were invited to complete a survey about LS at 3, 12, 24 and 36 months after surgery as part of their follow-up. The survey consisted primarily of validated tools, supplemented by a few ad hoc items, measuring bowel, urinary and sexual dysfunction, pain and quality of life and an additional question regarding request for contact. Patients completed surveys electronically or on paper. RESULTS: Of the 1721 invited patients, 1386 (80.5%) were included (1085 with colon cancer and 301 with rectal cancer) of whom 72.5% responded electronically. Patients responding electronically were 7.6 years younger than those responding on paper (P < 0.001). Since some patients answered more than once, the dataset consisted of 2361 surveys. Patients with colon cancer requested phone contact in 19.0% of the surveys, and 8.4% were referred to treatment for LS, primarily bowel dysfunction. Among patients with rectal cancer, 30.8% requested phone contact and 16.2% were referred for treatment of LS, mainly due to bowel and sexual dysfunction. CONCLUSION: This is the first paper investigating a new method of systematic screening for LS following colorectal cancer using electronic patient-reported outcome measures. The study shows that in the Danish population a high response rate can be obtained with this method and that close to three-quarters of patients respond electronically. Patients with rectal cancer had a higher need for phone contact and treatment of LS than patients with colon cancer.

Long-term gastrointestinal sequelae in colon cancer survivors: prospective pilot study on identification, the need for clinical evaluation and effects of treatment.

AIM: The aim of the present pilot study was to describe the type and frequency of long-term gastrointestinal symptoms within a well-defined cohort of colon cancer survivors, their wish for clinical evaluation and treatment outcomes. METHOD: A screening survey was sent to colon cancer survivors 12, 24 and 36 months after surgery. Based on their main symptoms, patients who wished to have a consultation were referred to the gastroenterological or surgical unit of our late cancer sequelae clinic. Treatment effect was monitored by questionnaires on bowel symptoms and the EuroQol five-dimensional (EQ-5D) quality-of-life score. RESULTS: Overall, 953 patients who had survived colon cancer received the screening survey and 767 replied (response rate 80.5%). Of these, 76 (9.9%; 95% CI 7.9%-12.2%) were referred for algorithm-based clinical evaluation and treatment of bowel dysfunction. The majority were women (69.7%) who had undergone a right-sided colonic resection (65.8%). Patients reported various symptoms, mainly including urgency, fragmented defaecation, loose stools and incontinence for liquid stools. Patients with emptying difficulties and low anterior resection syndrome-like symptoms were referred to the surgical unit and patients with diarrhoea were referred to the gastroenterological unit for clinical work-up. Our main endpoint, mean EQ-5D index after treatment, was improved compared with baseline (baseline 0.809, after treatment 0.846; p = 0.049). After treatment, self-rated bowel function and several bowel symptoms were improved as well. CONCLUSION: This study highlights the importance of identifying colon cancer survivors in need of treatment of late gastrointestinal sequelae and clinical management in a multidisciplinary team setting.

Normative Data for the Low Anterior Resection Syndrome Score (LARS Score).

OBJECTIVE: To provide normative data for the Low Anterior Resection Syndrome (LARS) score. BACKGROUND: The LARS score is a validated and frequently used tool measuring bowel dysfunction after sphincter sparing surgery for rectal cancer. The interpretation of LARS score results has previously been limited by the lack of normative data. METHODS: An age and sex-stratified random sample of 3440 citizens from the general population was drawn from the Danish civil registration system (age range 20-89 years, 50% females). A brief questionnaire including the LARS score and health-related items were distributed electronically or by post. RESULTS: A total of 1875 (54.5%) responded, 54.0% were females. In the age group 50 to 79 years, relevant for most rectal cancer studies, the response rate was 70.5% (n = 807). In this specific age group, 18.8% of the females and 9.6% of the males had a LARS score ≥30, corresponding to the LARS score category "major LARS" (P = 0.001), and the median (interquartile range) LARS score was 16 (7-26) and 11 (4-22), respectively (P < 0.001). Responders with physical disease had a statistically significant higher risk of a LARS score ≥30, compared with responders without any physical disease (odds ratio 2.2, 95% confidence interval 1.6-2.9, P < 0.001). CONCLUSIONS: A LARS score ≥30 (major LARS) is common in the general population, especially in the age group 50 to 79 years. Normative data for the LARS score are now available and can be taken into account when interpreting LARS score results in scientific studies of bowel function after rectal cancer treatment.

Low Anterior Resection Syndrome and Quality of Life After Sphincter-Sparing Rectal Cancer Surgery: A Long-term Longitudinal Follow-up.

BACKGROUND: Despite low anterior resection syndrome being a well-known consequence of sphincter-preserving rectal cancer surgery, the long-term effect on bowel function and quality of life is not fully understood. OBJECTIVE: This study aimed to elucidate whether symptoms of low anterior resection syndrome change over time and if the correlation to quality of life is equivalent when measured at 2 time points. DESIGN: This prospective cohort study included measurements at 2 time points (5 years between; range, 7.1-16.1 years from surgery to second follow-up). SETTINGS: This multicenter study included patients from Sweden and Denmark. PATIENTS: Patients were included if they were ≥18 years of age and underwent curative rectal cancer surgery with either total or partial mesorectal excision. MAIN OUTCOME MEASURES: Outcomes were measured with the low anterior resection syndrome questionnaire including a question assessing the impact of bowel function on quality of life and with the validated quality-of-life questionnaire EORTC QLQ-C30. RESULTS: In total, 282 patients were included and there were no statistically significant differences in the distribution among the 3 groups (no, minor, and major low anterior resection syndrome) when comparing time points follow-up 1 with follow-up 2 (p = 0.455). At follow-up 2, 138 patients (49%) still experienced major impairment. No both statistically and clinically significant differences were seen in the mean score of EORTC QLQ-C30 when comparing the same low anterior resection syndrome group at follow-up 1 and follow-up 2, and the impact on quality of life was comparable. Global health status/quality of life was impaired in the major low anterior resection syndrome group at both follow-up 1 (p < 0.001) and follow-up 2 (p < 0.001). LIMITATIONS: The study design prevents an evaluation of causality. CONCLUSIONS: Difficulties with low anterior resection syndrome and the impact on patients' quality of life persist over time. See Video Abstract at http://links.lww.com/DCR/A762.

Differences in baseline characteristics and 1-year psychological factors between participants and non-participants in the randomized, controlled trial regarding patient-led follow-up after rectal cancer (FURCA).

Background: The ongoing multi-center randomized FURCA-trial investigates the effect of patient-led follow-up after rectal cancer, aiming at improving management of late effects and survivorship care. The purpose of this present sub-study was to identify potential systematic differences between participants and non-participants in the FURCA-trial, in regard to demographic and clinical factors at baseline, and in quality of life (QoL) and fear of cancer recurrence (FCR) after one year. Material and methods: The population comprised patients invited to the FURCA-trial during the first 13 months' recruitment. Clinical and demographic data was obtained at baseline and differences were significance tested. Non-participants were requested to fill in a short survey one year after primary surgery, while participants received the questionnaires as part of more comprehensive one-year follow-up. Results: In the first 13 months of the trial, 113 out of the 262 patients invited, declined to participate. The main reason reported for this was lack of energy surplus. Participants were younger than non-participants (p < .01), and nonparticipation was particularly evident among patients ≥ 80 years. More than half of the invited females declined to participate. Good WHO Performance status was associated with participation (p = .01), yet there were no statistically significant differences in Charlson Comorbidity Index, type of surgery, oncological treatment or UICC stages between participants and non-participants. By one year after surgery, there was no difference in FCR-level (p = .92) and QoL (p = .25) between the non-participants and control group participants. Conclusion: The sub-study found that participants and non-participants differed at baseline in regard to age, gender and performance status, which is supported by results from other studies. No between-group differences were found in psychological factors after one year. These findings are important for the generalisability of the upcoming results from the trial.

Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score.

OBJECTIVE: Bowel dysfunction is common following a restorative rectal cancer resection, but symptom severity and the degree of quality of life impairment is highly variable. An internationally validated patient-reported outcome measure, Low Anterior Resection Syndrome (LARS) score, now enables these symptoms to be measured. The study purpose was: (1) to develop a model that predicts postoperative bowel function; (2) externally validate the model and (3) incorporate these findings into a nomogram and online tool in order to individualise patient counselling and aid preoperative consent. DESIGN: Patients more than 1 year after curative restorative anterior resection (UK, median 54 months; Denmark (DK), 56 months since surgery) were invited to complete The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version3 (EORTC QLQ-C30 v3), LARS and Wexner incontinence scores. Demographics, tumour characteristics, preoperative/postoperative treatment and surgical procedures were recorded. Using transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines, risk factors for bowel dysfunction were independently assessed by advanced linear regression shrinkage techniques for each dataset (UK:DK). RESULTS: Patients in the development (UK, n=463) and validation (DK, n=938) datasets reported mean (SD) LARS scores of 26 (11) and 24 (11), respectively. Key predictive factors for LARS were: age (at surgery); tumour height, total versus partial mesorectal excision, stoma and preoperative radiotherapy, with satisfactory model calibration and a Mallow's Cp of 7.5 and 5.5, respectively. CONCLUSIONS: The Pre-Operative LARS score (POLARS) is the first nomogram and online tool to predict bowel dysfunction severity prior to anterior resection. Colorectal surgeons, gastroenterologist and nurse specialists may use POLARS to help patients understand their risk of bowel dysfunction and to preoperatively highlight patients who may require additional postoperative support.

Population-based normative data for the inflammatory bowel disease fatigue scale - IBD-F.

OBJECTIVE: Fatigue is a common concern among patients with inflammatory bowel disease (IBD). The Inflammatory Bowel Disease Fatigue (IBD-F) scale was developed in 2014 together with patients with IBD. The IBD-F comprises five questions about the frequency and severity of fatigue followed by 30 questions about the experience and impact of fatigue. All questions have generic character. Normative values are needed if the IBD-F scale is to be used extensively. This study aims to generate normative values for the IBD-F scale in a Danish background population. MATERIALS AND METHODS: An age- and gender-stratified random sample of 3460 Danes was drawn from the total population. The IBD-F and a few socio-demographic questions were administered electronically. RESULTS: Of the 3460 drawn individuals, 2952 citizens with electronic access were invited to participate, 1925 (65.2%) citizens accepted the invitation, and 1761 (59.7%) completed the IBD-F questionnaire. Overall, women had more fatigue than men (the frequency and severity, 7.2 vs. 6.6; p < .001) (the experience and impact, 17.0 vs. 13.5; p < .001). Fatigue was most marked for citizens <50 and ≥80 years old. Having no education, working part time, and morbidity were factors associated with more fatigue. Co-habitation was associated with less fatigue. The internal consistency in this population revealed Cronbach's alpha values >0.85. CONCLUSIONS: The IBD-F scale can be used in the background population and this study provides normative data for fatigue. Fatigue was higher for women and specific age groups. Several socio-demographic and morbidity variables were associated with fatigue.

Follow-up after rectal cancer: developing and testing a novel patient-led follow-up program. Study protocol.

BACKGROUND: The main treatment for non-metastatic rectal cancer (RC) is surgical resection. Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. Patients and clinicians have requested a more patient-centred follow-up, balancing the focus on detection of recurrence, and physiological and psychological late adverse effects. The current follow-up program primarily focuses on detection of recurrence, with less attention on late adverse effects. As a consequence, the randomized controlled trial Follow-up after Rectal Cancer (FURCA) has been launched, testing the effect of a new patient-led, follow-up program. The aim of this paper is to describe the methodology used in the FURCA study and to report results from the development of the patient-led, follow-up program. Adult patients, treated with curative intent for primary adenocarcinoma in the rectum are included from four Danish centers. MATERIAL AND METHODS: Patients are randomized into an intervention group, receiving standardized education and access to self-referral to an assigned project nurse, or a control group following the current follow-up program with routine medicals. The primary outcomes are symptom burden and quality of life, measured by the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire. Other outcome and demographic data are collected as patient-reported measures and register-based data. Results from developing the intervention: The education program is based on data from two focus group interviews and the feedback from experts. An algorithm is developed in order to qualify the research nurses' responses to patients' self-referral. Discussion and perspectives: The results of the FURCA study will strengthen the evidence base for RC follow-up, and qualify the ongoing transformation in cancer follow-up programs.

Predicting the Risk of Bowel-Related Quality-of-Life Impairment After Restorative Resection for Rectal Cancer: A Multicenter Cross-Sectional Study.

BACKGROUND: Restorative anterior resection is considered the optimal procedure for most patients with rectal cancer and is frequently preceded by radiotherapy. Both surgery and preoperative radiotherapy impair bowel function, which adversely affects quality of life. OBJECTIVE: This study aimed to report symptoms associated with and key predictors for bowel-related quality-of-life impairment. DESIGN: The study included a cross-sectional cohort. SETTINGS: This was a multicenter study from 12 United Kingdom centers. PATIENTS: A total of 578 patients with rectal cancer underwent curative restorative anterior resection between 2001 and 2012 (median, 5.25 years postsurgery). MAIN OUTCOME MEASURES: Patients completed outcome measures that assessed bowel dysfunction (low anterior resection syndrome score), incontinence (Wexner score), and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30), plus an anchor question: "Overall how does bowel function affect your quality of life?" RESULTS: The response rate was 80% (462/578). Overall, 85% (391/462) of patients reported bowel-related quality-of-life impairment, with 40% (187/462) reporting major impairment. A large difference in global quality of life (22 points; p < 0.001) was reported for "none" versus "major" impairment, with greatest symptom severity being diarrhea (25 points; p < 0.001), insomnia (24 points; p < 0.001), and fatigue (20 points; p < 0.001). Regression analysis identified major impairment in 60% and 45% of patients with low rectal cancer treated with and without preoperative radiotherapy compared with 47% and 33% of middle/upper rectal cancers with and without preoperative radiotherapy. LIMITATIONS: Advances in radiotherapy delivery and improvements in posttreatment symptom control, although currently of limited efficacy, imply that the content of this consent aid should be re-evaluated in 5 to 10 years. CONCLUSIONS: Before a restorative anterior resection, patients with rectal cancer should be informed that bowel-related quality-of-life impairment is common. The key risk factors are neoadjuvant therapy and a low tumor height. This study presents quality-of-life and functional outcome data, along with a consent aid, that will enhance this preoperative patient discussion.