Jane Conyers, Mercer University College of Pharmacy
Anastomotic leakage, and its accompanying risk of infection, is a complication of colorectal resection in the treatment of rectal cancer. Temporary stoma have been used to divert fecal drainage and reduce the risk of leakage.  These temporary ileostomies and colostomies require a second operation to restore intestinal continuity. Guidelines for ostomy surgery noted evidence for differing surgical techniques for ostomy closure, but concluded there was insufficient evidence to provide guidance on the timing of ostomy reversal surgery. 
|Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial|
|Design||Randomized, controlled, multi-center trial; N= 112|
|Objective||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|
|Study Groups||Early closure (n= 55); standard closure (n= 57)|
|Methods||Total mesorectal excision (TME) surgical patients with temporary ileostomies were assessed on post-surgical days one and four for signs of infection or leakage. Computed tomography scans (CT-scan) were performed between days six and eight to check for anastomotic leakage. Patients were then assigned to early or standard surgical stoma closure. Patients were followed up at 3, 6, and 12 months after TME. Complications included skin irritation, stomal ulcer, parastomal infection, leakage outside appliance bag, high volume output, stenosis, prolapse, and retraction. Statistical significance was set at p< 0.0001.|
|Primary Outcome Measure||Mean total number of complications within 12 months after TME|
** Union for International Cancer Control
|Adverse Events||Common Adverse Events in early closure: skin irritation (3%), stomal ulcer (2%), parastomal infection (1%) leakage outside appliance bag (3%), high volume output (5%), stenosis (2%), other (1%)|
|Serious Adverse Events in early closure: renal failure due to high volume output (1.8%)|
|Percentage that Discontinued due to Adverse Events: 0%|
|Study Author Conclusions||In selected patients without clinical, radiological or endoscopic signs of a leakage early closure of the temporary ileostomy after surgery for rectal cancer resulted in a lower mean number of complications compared with late closure, and low numbers of severe complications in both groups.|
Early closure of stomas in this patient population would be associated with better quality of life, since it provides one less challenge in dealing with the primary cancer diagnosis. While a thorough examination of the anastomosis to ensure there are no signs of leakage would add to the total cost of the procedure, it may serve to decrease the total length of hospital stay. A strength of this study was the length of follow up time, which was sufficient to evaluate the safety of the early intervention. However, the study was limited by the missing baseline cancer stage stratification. With this data, outcomes could have been differentiated between early and late stage patients.
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- Hendren S, Hammond K, Glasgow SC, et al. Clinical practice guidelines for ostomy surgery. Dis Colon Rectum. 2015;58(4):375-87.
- Danielsen AK, Park J, Jansen JE, et al. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017;265(2):284-290.