Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Detailed Description
-----------------
Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence. Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction. The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

Official Title
-----------------
A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer

Conditions
-----------------
Rectal Cancer, Treatment, Postoperative Complications, Neoplasm Recurrence, Local, Survival Rate

Intervention / Treatment
-----------------
* Procedure: cylindrical abdominoperineal resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor within 6 cm of the anal verge, or with very narrow pelvis T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination Absence of distant metastases Absence of intestinal obstruction Exclusion Criteria: T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination with distant metastases with intestinal obstruction pregnancy or lactation allergic constitution to heterogeneous protein with operation contraindication with mental disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cylindrical abdominoperineal resection<br>patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer | Procedure: cylindrical abdominoperineal resection<br>* Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer<br>* Other names: Ruinuo;|
| abdominoperineal resection<br>patients underwent conventional abdominoperineal resection for advanced very low rectal cancer | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications |  | 08/01/2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years overall survival |  | 08/01/2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cylindrical abdominoperineal resection, rectal cancer, acellular dermal matrix, pelvic reconstruction, circumferential resection margin, overall survival