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

• Sponsor: Beijing Chao Yang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00949273
• Collaborator: Shandong Provincial Hospital (Other), Shandong Cancer Hospital and Institute (Other), The First Affiliated Hospital of Zhengzhou University (Other), Wuhan University (Other), Shenyang Anorectal Hospital (Other), Beijing Luhe Hospital (Other)
• Enrollment: 300
• Locations: 7
• Duration (Months): 52
• Patients Per Site: 42.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Treatment; Postoperative Complications; Neoplasm Recurrence, Local; Survival Rate	Procedure: cylindrical abdominoperineal resection

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• 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
• Study Start Date: Jul 1, 2009
• Anticipated Primary Completion Date: Nov 1, 2013
• Anticipated Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Ruinuo
abdominoperineal resection patients underwent conventional abdominoperineal resection for advanced very low rectal cancer

Outcome Measures

Primary Outcome Measures

1. postoperative complications [08/01/2011]

Secondary Outcome Measures

1. 3-years overall survival [08/01/2013]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Beijing Luhe Hospital	Beijing	Beijing	China	100000
2	General Surgery, Beijing Chao Yang Hospital	Beijing	Beijing	China	100020
3	The first Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450003
4	Zhongnan Hospital, Wuhan University	Wuhan	Hubei	China	430077
5	Shenyang Anorectal Hospital	Shenyang	Liaoning	China	110002
6	General Surgery, Shandong Provincial Hospital	Jinan	Shandong	China	250022
7	Shandong Cancer Hospital and Institute	Jinan	Shandong	China	250117

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 Chao Yang Hospital
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhen Jun Wang, Professor and Head of General Surgery, Beijing Chao Yang Hospital
• ClinicalTrials.gov Identifier: NCT00949273
• Other Study ID Numbers: CAPR0668
• First Posted: Jul 30, 2009
• Last Update Posted: Nov 28, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Zhen Jun Wang, Professor and Head of General Surgery, Beijing Chao Yang Hospital: cylindrical abdominoperineal resection; rectal cancer; acellular dermal matrix; pelvic reconstruction; circumferential resection margin; overall survival
• Additional relevant MeSH terms: Rectal Neoplasms; Neoplasm Recurrence, Local; Recurrence; Postoperative Complications

Study Results

No Results Posted as of Nov 28, 2013