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

Overview

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

Full Title of Study: “A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2013

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.

Interventions

  • Procedure: cylindrical abdominoperineal resection
    • Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer

Arms, Groups and Cohorts

  • cylindrical abdominoperineal resection
    • patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer
  • abdominoperineal resection
    • patients underwent conventional abdominoperineal resection for advanced very low rectal cancer

Clinical Trial Outcome Measures

Primary Measures

  • postoperative complications
    • Time Frame: 08/01/2011

Secondary Measures

  • 3-years overall survival
    • Time Frame: 08/01/2013

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Chao Yang Hospital
  • Collaborator
    • Shandong Provincial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhen Jun Wang, Professor and Head of General Surgery – Beijing Chao Yang Hospital
  • Overall Official(s)
    • Zhen Jun Wang, M.D., Study Chair, Beijing Chao Yang Hospital
    • Yong Dai, M.D., Principal Investigator, Shandong Provincial Hospital
    • Heng Ma, M.D., Principal Investigator, Shandong Cancer Hospital and Institute
    • Qun Qian, M.D., Principal Investigator, Zhong Nan Hospital, Wuhan University
    • Xian Dong Zeng, M.D., Principal Investigator, Shenyang Anorectal Hospital
    • Jian Hua Cai, M.D., Principal Investigator, Beijing Luhe Hospital
    • Wei Tang Yuan, M.D., Principal Investigator, The First Affiliated Hospital of Zhengzhou University
  • Overall Contact(s)
    • Zhen Jun Wang, M.D., 86-013601393711, wang3zj@sohu.com

Citations Reporting on Results

Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.