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.

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.

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.

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.

Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).

BACKGROUND: Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS: Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS: Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS: The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

The type of stoma matters-morbidity in patients with obstructing colorectal cancer.

PURPOSE: A loop colostomy may reduce the risk of severe intraabdominal complications in patients with obstructing colorectal cancer compared to an end colostomy. The aim of this study was to relate complications to the type of stoma, and a secondary aim was to evaluate whether the type of colostomy had an impact on time until oncological/surgical treatment. METHODS: All patients who underwent surgery and received a deviating colostomy due to obstructing colorectal cancer between January 2011 and December 2015 in five Swedish hospitals in Region Västra Götaland were included (n = 289). Patient charts were reviewed retrospectively. Patients alive in the end of 2016 were contacted and were sent a questionnaire including questions about stoma function and health-related quality of life. RESULTS: Some 289 patients were included; 147 received an end colostomy and 140 a loop colostomy. Two patients were excluded from the analysis due to missing data. There was no difference in complications at 90 days between the two groups, 44% (end colostomy) and 54% (loop colostomy) (odds ratio: 0.83 (95% CI: 0.49; 1.41). Time to start of treatment was similar in both groups. Patients with a loop colostomy had significantly higher stoma-related morbidity with retraction, prolapse, leakage and bandaging problems. No differences in quality of life were found. CONCLUSION: The hypothesis that a loop colostomy reduced complications could not be confirmed. An end colostomy should be the first choice in these patients particularly in patients who will have their colostomy for the remainder of their life to reduce stoma-related symptoms.

Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. BACKGROUND: A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. METHODS: Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. RESULTS: The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. CONCLUSIONS: It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.