Rectal Cancer Clinical Trial
Official title:
Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal
resection rectum is still a debate.
This study purpose is to demonstrate that preventive loop ileostomy is characterized by a
higher readmission rate caused by dehydration, in comparison with the loop colostomy.
Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is
proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication
that reduces quality of life of patients and increases the risk of disease reccurence.
The presence of preventive stoma is an effective way to avoid this complication that is why
it's included to treatment protocols for the middle and low ampullary rectal cancers is
undisputed by the most of surgeons. However, the type of preventive stoma is under discussion
yet and remains to be an urgent issue.
The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often
for the protection of low colorectal anastomoses. In the western countries the preferred
method is double barreled ileostomy due to more rapid formation and closure, as well as due
to lower rate of stoma-related morbidity.
In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of
defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and
related hospital admissions, along with series of unproven advantages.
Presented study will allow to reveal the early and late postoperative morbidity rate and the
related hospital re-admissions in real-life clinical practice of Russia from the standpoints
of evidence- based medicine, to define indications and contraindications for each type of
"low" colorectal anastomosis protection with the least risk for the patient.
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