Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer
NCT ID: NCT00949273
Last Updated: 2013-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2009-07-31
2013-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cylindrical abdominoperineal resection
patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer
cylindrical abdominoperineal resection
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
abdominoperineal resection
patients underwent conventional abdominoperineal resection for advanced very low rectal cancer
No interventions assigned to this group
Interventions
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cylindrical abdominoperineal resection
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* with distant metastases
* with intestinal obstruction
* pregnancy or lactation
* allergic constitution to heterogeneous protein
* with operation contraindication
* with mental disorder
18 Years
80 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
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
Beijing Chao Yang Hospital
OTHER
Responsible Party
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Zhen Jun Wang
Professor and Head of General Surgery
Principal Investigators
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Zhen Jun Wang, M.D.
Role: STUDY_CHAIR
Beijing Chao Yang Hospital
Yong Dai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Heng Ma, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Qun Qian, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhong Nan Hospital, Wuhan University
Xian Dong Zeng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shenyang Anorectal Hospital
Jian Hua Cai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Luhe Hospital
Wei Tang Yuan, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Beijing Luhe Hospital
Beijing, Beijing Municipality, China
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital, Wuhan University
Wuhan, Hubei, China
Shenyang Anorectal Hospital
Shenyang, Liaoning, China
General Surgery, Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Jian Hua Cai, M.D.
Role: primary
Jia Gang Han, M.D.
Role: primary
Wei Tang Yuan, M.D.
Role: primary
Qun Qian, M.D.
Role: primary
Xian Dong Zeng, M.D.
Role: primary
Yong Dai, M.D.
Role: primary
Heng Ma, M.D.
Role: primary
References
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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.
Other Identifiers
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CAPR0668
Identifier Type: -
Identifier Source: org_study_id