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

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00949273
Enrollment
300
Registered
2009-07-30
Start date
2009-07-31
Completion date
2013-11-30
Last updated
2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cylindrical abdominoperineal resection, rectal cancer, acellular dermal matrix, pelvic reconstruction, circumferential resection margin, overall survival

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

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

PROCEDUREcylindrical abdominoperineal resection

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

Sponsors

Shandong Provincial Hospital
CollaboratorOTHER_GOV
Shandong Cancer Hospital and Institute
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Wuhan University
CollaboratorOTHER
Shenyang Anorectal Hospital
CollaboratorOTHER
Beijing Luhe Hospital
CollaboratorOTHER
Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
postoperative complications08/01/2011

Secondary

MeasureTime frame
3-years overall survival08/01/2013

Countries

China

Contacts

Primary ContactZhen Jun Wang, M.D.
wang3zj@sohu.com86-013601393711
Backup ContactJia Gang Han, M.D.
wzhj611@163.com86-013522867841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026