Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: transanal anastomotic reinforcement; Procedure: protective ileostomy group; Device: a circular anal dilator (CAD)

• Registration Number: NCT02279771
• Lead Sponsor: Donato F Altomare

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

Not available

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Study Start: 2015-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transanal anastomotic reinforcement	transanal anastomotic reinforcement	Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
protective ileostomy group	protective ileostomy group	Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
transanal anastomotic reinforcement	a circular anal dilator (CAD)	Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)

Primary Outcome Measures

Name	Time	Method
anastomotic leak	30 postoperative days	anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis

Secondary Outcome Measures

Name	Time	Method
duration of the two operations	Intraoperative	the duration in minutes of the two types of operation
Number of overall postoperative complications	30 postoperative days