Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Study Overview
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Brief Summary
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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

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: transanal anastomotic reinforcement
* Procedure: protective ileostomy group
* Device: a circular anal dilator (CAD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transanal anastomotic reinforcement<br>Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR) | Procedure: transanal anastomotic reinforcement<br>* 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.<br>Device: a circular anal dilator (CAD)<br>* Epo Flier, SapiMed SPA, Alessandria, Italy<br>|
| Active Comparator: protective ileostomy group<br>Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR) | Procedure: protective ileostomy group<br>* S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leak | anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis | 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the two operations | the duration in minutes of the two types of operation | Intraoperative | 
| Number of overall postoperative complications |  | 30 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal anastomosis, anastomotic leak, ileostomy, complications