Our March commentary is on a paper about the EASY trial which found that while early closure of the temporary ileostomy was associated with fewer complications, there was no effect on quality of life.
The Paper
Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial). Br J Surg. 2018 Feb;105(3):244-251. doi: 10.1002/bjs.10680. Epub 2017 Nov 23. Park J, Danielsen AK, Angenete E, Bock D, Marinez AC, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J
Background
A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy.
Methods
Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Participants were recruited after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®).
Results
There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months.
Conclusion
Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on patients' HRQOL.
Commentary
What is known on the subject
There are limited data on quality of life after rectal resection for cancer. The literature is generally poor due to the heterogenous cohorts of patients included – high and low anterior resection, use of diverting stoma, radiotherapy or chemoradiotherapy.
What this study adds
This study has shown that early closure of stoma is safe and these results may indicate that stomas are not needed in many patients. Further work needs to be done in this area with regards to low anterior resection syndrome (LARS) and longer term follow up is required.
Study design: This was a prospective RCT study on low anterior resection patients who had a defunctioning stoma in hospitals in Denmark and Sweden. Patients were randomized post-resection to have an early closure of their defunctioning stoma – between 8 and 13 days after stoma creation and late closure of stoma – more than 12 weeks after stoma creation.
Primary endpoint
This was the mean number of complications after rectal resection and up to 12 months which had been published previously. In their paper in Annals of Surgery 2017 Feb;265(2):284-290 the mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (early closure of stoma) (1.2) compared with the control group (late closure) (2.9), P < 0.0001.
Secondary endpoints
Included outcomes were HRQOL and QOL at 3, 6 and 12 months. The tools used were the SF36, EORTC QLC-C-30 and QLQ-CR-29.
Patients
Between February 2011 and November 2015, 418 patients were assessed for eligibility. A total of 112 patients (26.8%) were randomized: 55 into the intervention group (early closure of stoma) and 57 to a control group (late closure). Apart from a larger proportion of women in the early closure group, demographic and clinical data were comparable in the two groups.
Results
Questionnaire responses were in the region of 90%, however incomplete EORTC QLC-C-30 questionnaires were given to 20 of the patients in the intervention group (early closure of stoma) and 16 in the control group (late closure). SF-36 scores were similar between the two groups except for the following significant differences: ‘physical role’ was significantly better in the early closure group at 3 months; body pain and mental health were significantly better in the late closure group at 12 months.
Author interpretation
Early reversal of stoma was safe. Health related quality of life did not differ within 12 months in patients who had an early or late closure of temporary stoma. Global related quality of life generally improved in the 6-12 month period but did not differ if the stoma was closed early or late.
Comments on the study
The paper is well written, and the limitations clearly defined. There are no pre-operative data available for comparison and no longer term data available. In depth analysis of clinical symptom patterns and psychological status in the two groups may shed light on the failure to find a difference in QOL related outcome measures in the two groups. No length of hospital stay or cost benefit analysis has been included.
Implications for colorectal practice
This study did not demonstrate a difference in most domains of quality of life for patients who had early or late closure of stoma.
An analysis of acceptability of a short term stoma verses a longer term stoma should be undertaken at the time of consenting for surgery to see if there is a reduction in anxiety levels. Long term, hospital stay and cost analysis are also needed.
The LARRIS Trial has suggested that restoration of continuity within 6 months is protective against LARS. Further studies of the effect of very early closure, as was done in this study, are also required in relation to the incidence of LARS.
Reference
Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Ann Surg. 2017 Feb;265(2):284-290.