Spots Global Cancer Trial Database for Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

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Trial Identification

Brief Title: Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

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

Study ID: NCT02279771

Conditions

Rectal Cancer

Interventions

transanal anastomotic reinforcement

protective ileostomy group

a circular anal dilator (CAD)

Study Description

Brief Summary: 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

Detailed Description: