Trial Information

Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)

Experimental intervention: Low anterior resection for rectal cancer < 12 cm from the anal
verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close
to the aorta, mobilization of the splenic flexure, radical lymph node dissection and
side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon
(3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by
introducing the stapler from the anus by the assistant surgeon while the surgeon is holding
the descending colon in the correct position. The anastomosis is performed on the
antimesenteric aspect of the descending colon. The length of the blind end is measured and
the integrity of the anastomosis is tested intraoperatively. The intended minimal distal
clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed
regularly which is intended to be closed 3 months postoperatively.

Control intervention: Low anterior resection for rectal cancer with total mesorectal
excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization
of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch
anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with
a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is
done by introducing the stapler from the anus by the assistant surgeon while the surgeon is
holding the descending colon in the correct position. The integrity of the anastomosis is
tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2
cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3
months postoperatively.

Follow-up per patient: 24 months postoperatively