Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Donato F Altomare140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Rectal Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement. Distal margin of the tumor at least 6 cm form the anal verge Staged as follows prior to neoadjuvant chemoradiation: Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery Exclusion Criteria: * Squamous cell carcinoma * Adenocarcinoma Stage T1, * T4 with one of the following: with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) * Unresectable primary rectal cancer or Inability to complete R0 resection. * Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis * Recurrent rectal cancer * Previous pelvic malignancy * Inability to sign informed consent * Pregnancy

Outcomes

Primary Outcomes

anastomotic leak

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

Time frame: 30 postoperative days

Secondary Outcomes

duration of the two operations

the duration in minutes of the two types of operation

Time frame: Intraoperative

Number of overall postoperative complications