Affiliation:
1. Department of Colorectal Surgery, National Cancer Center Hospital East , Kashiwa , Japan
2. Biostatistics Division, Center for Research Administration and Support, National Cancer Center Hospital East , Kashiwa , Japan
Abstract
Abstract
Background
Currently, hand-sewn anastomosis is the standard procedure for inter-sphincteric resection (ISR); however, distal purse-string suturing during transanal total mesorectal excision (TaTME) has allowed a single-stapling technique (SST). Although it was originally intended for cases requiring anastomosis of 2 cm or more above the anorectal junction (ARJ), SST could be safely performed in ISR. The aim of this trial is to determine the superiority of SST over hand-sewn anastomosis in ISR with TaTME.
Methods
The Super SST trial is a multicentre randomized clinical trial comparing stapled and hand-sewn anastomoses in ISR with TaTME. The trial will recruit patients scheduled for TaTME with anastomosis below the ARJ, who will be allocated 1:1 to receive either hand-sewn or stapled anastomosis. The primary endpoint is anastomosis-related complications within 30 postoperative days. Secondary endpoints include all early and late complications, operating time, reoperation, mortality rate, length of postoperative hospital stay, readmission, incidence of anal pain and rectal mucosal prolapse, length of temporary stoma retention, the proportion of patients with a temporary stoma at 1 year after surgery, and anorectal function at 1 year after surgery.
Conclusion
This trial will provide important clinical insights for new and promising anastomotic options for patients with very low rectal cancer.
Registration number: UMIN000047818 (https://www.umin.ac.jp/ctr/index-j.htme).
Publisher
Oxford University Press (OUP)
Cited by
2 articles.
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