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

Capital Medical University

Status

Unknown

Conditions

Postoperative Complications

Treatment

Survival Rate

Neoplasm Recurrence, Local

Rectal Cancer

Treatments

Procedure: cylindrical abdominoperineal resection

Study type

Observational

Funder types

Other

Identifiers

NCT00949273

CAPR0668

Details and patient eligibility

About

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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