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Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)

Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)

a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired.

Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.

transanal anastomotic reinforcement

S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.

protective ileostomy group

Epo Flier, SapiMed SPA, Alessandria, Italy

a circular anal dilator (CAD)

Donato F Altomare, MD

Maria Di Lena, MD

Arcangelo Picciariello, MD

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery

anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis

the duration in minutes of the two types of operation

Spots Global Cancer Trial Database for a circular anal dilator (cad)