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. 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. Patient characteristics and clinical factors explained 4–10

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 >= 20years 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.

OBJECTIVE:The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer.SUMMARY BACKGROUND DATA:Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery.METHODS:Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years. Primary endpoint was local recurrence at 3-year follow-up. Secondary endpoints included bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints.RESULTS:All 1044 patients included in the COLOR II trial were analyzed. There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer.CONCLUSION:Based on long-term morbidity outcomes, laparoscopic surgery for rectal cancer could be considered a routine technique as there are no differences with open surgery.

Previous studies regarding the comparative costs of laparoscopic and open surgery for rectal cancer provide ambiguous conclusions, and there are no large randomized trials or long-term follow-up.

To compare incremental costs of laparoscopic and open surgery for rectal cancer within a large randomized trial (COLOR II) with long-term follow-up. Data of clinical resource use from the randomized controlled trial COlorectal cancer Laparoscopic or Open Resection (COLOR) II was used to perform a prospective cost-minimization analysis. Some data were retrospectively collected for COLOR II-patients operated at the largest participating Swedish hospital (n=105). Sick leave data was provided by the Swedish social insurance agency. Unit costs were collected from Swedish sources. The primary outcome was the difference in mean cost between laparoscopic and open surgery. One-way sensitivity analysis was used to check robustness of the results. The COLOR II trial enrolled 1044 rectal cancer patients between 2004-2010 randomized between laparoscopic and open surgery 2:1. At the three-year follow-up data for the clinical variables used in the analysis were available for 74-89 % of patients. Laparoscopic surgery was more costly to the health care sector than the open technique, both at 28 days ($1910, 95% CI: 677 to 3143) and three years ($3854, 95%CI: 1527 to 6182) after surgery. There were, however, no differences in long-term costs to society between laparoscopic and open surgery ($684, 95% CI: -5799 to 7166). Results were sensitive to length of hospital stay, sick leave and the cost for stoma materials as demonstrated in one-way sensitivity analysis. The study found short and long-term cost differences for the health care sector. There was no significant difference in regards to long-term societal perspective. Future research is suggested to investigate the effects of sick leave costs using material from a greater number of patients.

BACKGROUND:This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer.METHODS:Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning, sexual enjoyment, male and female sexual problems, and micturition symptoms.RESULTS:Of 617 randomized patients, 385 completed this phase of the trial. Their mean age was 67·1 years. Surgery caused an anticipated reduction in genitourinary function after 4 weeks, with no significant differences between laparoscopic and open approaches. An improvement in sexual dysfunction was seen in the first year, but some male sexual problems persisted. Before operation 64·5 per cent of men in the laparoscopic group and 55·6 per cent in the open group reported some degree of erectile dysfunction. This increased to 81·1 and 80·5 per cent respectively 4 weeks after surgery, and 76·3 versus 75·5 per cent at 12 months, with no significant differences between groups. Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by 6 months. Adjusting for confounders, including radiotherapy, did not change these results.CONCLUSION:Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this.REGISTRATION NUMBER:NCT00297791 (http://www.clinicaltrials.gov).

Introduction: Rectal cancer treatment, especially abdominoperineal excision (APE), can cause sexual dysfunction. There are indications that pre-operative information regarding sexual dysfunction is inadequate. The aim of this study was to explore self reported sexual function in a group of patients operated with APE and the patients' remembrance of preoperative information more than one year after their surgical procedure. Methods: Consecutive patients with rectal cancer operated with APE in one institution between 2004 and 2009 were included. Data was collected from hospital records and the Swedish Colorectal cancer registry. A detailed questionnaire was sent out to the patients 13-84 months post-operatively. Results: One hundred and eight patients were alive in February 2011, 84 agreed to participate and 89% returned the questionnaire. Men and women did not differ regarding age, tumour stage, neoadjuvant treatment or type of surgical procedure. More men were involved in a relationship; men had more thoughts about sex, were less satisfied and were more bothered than women by their sexual dysfunction. A majority of patients did not retain sufficient knowledge from the preoperative information regarding sexual dysfunction. Discussion: This exploratory study shows that although sexual activity was similar between the two genders, men reported more bother by their self-reported sexual dysfunction after an APE than women did. However, both men and women felt that the preoperative information was inadequate. Conclusion: Surgeons should focus more on information about the risk of sexual dysfunction as well as on its treatment at follow-up. Trial registration: ClinicalTrials.gov, NCT01323166. (C) 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

BACKGROUND:Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12 months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.METHODS:The setting was a multicentre randomized trial (COLOR II) comparing laparoscopic and open surgery for rectal cancer. Involvement in the HRQL study of COLOR II was optional. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38, and EuroQol - 5D (EQ-5D™) before surgery, and 4 weeks, 6, 12 and 24 months after operation. Analysis was done according to the manual for each instrument.RESULTS:Of 617 patients in hospitals participating in the HRQL study of COLOR II, 385 were included. The HRQL deteriorated to moderate/severe degrees after surgery, gradually returning to preoperative values over time. Changes in EORTC QLQ-C30 and QLQ-CR38, and EQ-5D™ were not significantly different between the groups regarding global health score or any of the dimensions or symptoms at 4 weeks, 6 or 12 months after surgery.CONCLUSION:In contrast to previous studies in patients with colonic cancer, HRQL after rectal cancer surgery was not affected by surgical approach.REGISTRATION NUMBER:NCT00297791 (http://www.clinicaltrials.gov).