This is the Scientific Surgery Archive, which contains all randomized clinical trials in surgery that have been identified by searching the top 50 English language medical journal issues since January 1998. Compiled by Jonothan J. Earnshaw, former Editor-in-Chief, BJS
Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma‐related complications (ISI trial). BJS 2018; 105: 637-644.
Published: 1st March 2018
Authors: M. F. Sier, D. D. Wisselink, D. T. Ubbink, R. J. Oostenbroek, G. J. Veldink, B. Lamme et al.
Background
Ileostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous
Method
This randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma‐related quality of life and costs of stoma‐related materials and reinterventions.
Results
Between April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4
Conclusion
Intracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma‐related complications did not differ between the two techniques. Registration number: NTR2369 (
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