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

• Conditions: Postoperative Complications; Survival Rate; Rectal Cancer; Treatment; Neoplasm Recurrence, Local

• Registration Number: NCT00949273
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative complications	08/01/2011

Secondary Outcome Measures

Name	Time	Method
3-years overall survival	08/01/2013

Trial Locations

Locations (7)

Beijing Luhe Hospital; 🇨🇳 Beijing, Beijing, China

General Surgery, Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China

The first Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Zhongnan Hospital, Wuhan University; 🇨🇳 Wuhan, Hubei, China

Shenyang Anorectal Hospital; 🇨🇳 Shenyang, Liaoning, China

General Surgery, Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China