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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Beijing Chao Yang Hospital
Sponsor:
Collaborators:
Shandong Provincial Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Wuhan University
Shenyang Anorectal Hospital
Beijing Luhe Hospital
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00949273
First received: July 29, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Rectal Cancer
Treatment
Postoperative Complications
Neoplasm Recurrence, Local
Survival Rate
Procedure: cylindrical abdominoperineal resection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 08/01/2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 3-years overall survival [ Time Frame: 08/01/2013 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

circumferential resection margin; bowel perforation; cross sectional tissue area outside the internal sphincter; mean distance from the internal sphincter to the anterior, posterior and lateral circumferential resection margins


Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cylindrical abdominoperineal resection
patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer
Procedure: cylindrical abdominoperineal resection
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
Other Name: Ruinuo
abdominoperineal resection
patients underwent conventional abdominoperineal resection for 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hospitalized patients with rectal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949273

Contacts
Contact: Zhen Jun Wang, M.D. 86-013601393711 wang3zj@sohu.com
Contact: Jia Gang Han, M.D. 86-013522867841 wzhj611@163.com

Locations
China, Beijing
Beijing Luhe Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jian Hua Cai, M.D.       caijianhua10020@163.com   
Principal Investigator: Jian Hua Cai, M.D.         
General Surgery, Beijing Chao Yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Jia Gang Han, M.D.    86-013522867841    hjg512@yahoo.com.cn   
Principal Investigator: Zhen Jun Wang, M.D.         
Sub-Investigator: Jia Gang Han, M.D.         
Sub-Investigator: Hua Chong Ma, M.D.         
Sub-Investigator: Yan Fu Du, M.D.         
Sub-Investigator: Min Zhe Li, M.D.         
China, Henan
The first Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450003
Contact: Wei Tang Yuan, M.D.    86-013673384555      
Principal Investigator: Wei Tang Yuan, M.D.         
China, Hubei
Zhongnan Hospital, Wuhan University Recruiting
Wuhan, Hubei, China, 430077
Contact: Qun Qian, M.D.    86-013517110773      
Principal Investigator: Qun Qian, M.D.         
China, Liaoning
Shenyang Anorectal Hospital Recruiting
Shenyang, Liaoning, China, 110002
Contact: Xian Dong Zeng, M.D.       zeng_xiandong@sina.com   
Principal Investigator: Xian Dong Zeng, M.D.         
China, Shandong
General Surgery, Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250022
Contact: Yong Dai, M.D.    86-013708933989      
Principal Investigator: Yong Dai, M.D.         
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250117
Contact: Heng Ma, M.D.    86-013954191086      
Principal Investigator: Heng Ma, M.D.         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Shandong Provincial Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Wuhan University
Shenyang Anorectal Hospital
Beijing Luhe Hospital
Investigators
Study Chair: Zhen Jun Wang, M.D. Beijing Chaoyang Hospital, Capital Medical University
Principal Investigator: Yong Dai, M.D. Shandong Provincial Hospital
Principal Investigator: Heng Ma, M.D. Shandong Cancer Hospital and Institute
Principal Investigator: Qun Qian, M.D. Zhong Nan Hospital, Wuhan University
Principal Investigator: Xian Dong Zeng, M.D. Shenyang Anorectal Hospital
Principal Investigator: Jian Hua Cai, M.D. Beijing Luhe Hospital
Principal Investigator: Wei Tang Yuan, M.D. The First Affiliated Hospital of Zhengzhou University
  More Information

Publications:
Responsible Party: Zhen Jun Wang, Professor and Head of General Surgery, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT00949273     History of Changes
Other Study ID Numbers: CAPR0668
Study First Received: July 29, 2009
Last Updated: November 26, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Chao Yang Hospital:
cylindrical abdominoperineal resection
rectal cancer
acellular dermal matrix
pelvic reconstruction
circumferential resection margin
overall survival

Additional relevant MeSH terms:
Neoplasm Recurrence, Local
Postoperative Complications
Rectal Neoplasms
Recurrence
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Disease Attributes
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014