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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00949273
• Other study ID #: CAPR0668
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2009
• Last updated: November 26, 2013
• Start date: July 2009
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Beijing Chao Yang Hospital
• Contact: Zhen Jun Wang, M.D.
• Phone: 86-013601393711
• Email: wang3zj[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm Recurrence, Local
• Postoperative Complications
• Rectal Cancer
• Rectal Neoplasms
• Recurrence
• Survival Rate
• Treatment

Intervention

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

Locations

Country	Name	City	State
China	Beijing Luhe Hospital	Beijing	Beijing
China	General Surgery, Beijing Chao Yang Hospital	Beijing	Beijing
China	General Surgery, Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Shenyang Anorectal Hospital	Shenyang	Liaoning
China	Zhongnan Hospital, Wuhan University	Wuhan	Hubei
China	The first Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	Beijing Luhe Hospital, Shandong Cancer Hospital and Institute, Shandong Provincial Hospital, Shenyang Anorectal Hospital, The First Affiliated Hospital of Zhengzhou University, Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Holm T, Ljung A, Häggmark 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications		08/01/2011	Yes
Secondary	3-years overall survival		08/01/2013	Yes