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
1 other identifier
observational
300
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 28, 2013
November 1, 2013
4.3 years
July 29, 2009
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative complications
08/01/2011
Secondary Outcomes (1)
3-years overall survival
08/01/2013
Study Arms (2)
cylindrical abdominoperineal resection
patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer
abdominoperineal resection
patients underwent conventional abdominoperineal resection for advanced very low rectal cancer
Interventions
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
Eligibility Criteria
hospitalized patients with rectal cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Chao Yang Hospitallead
- Shandong Provincial Hospitalcollaborator
- Shandong Cancer Hospital and Institutecollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Wuhan Universitycollaborator
- Shenyang Anorectal Hospitalcollaborator
- Beijing Luhe Hospitalcollaborator
Study Sites (7)
Beijing Luhe Hospital
Beijing, Beijing Municipality, 100000, China
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003, China
Zhongnan Hospital, Wuhan University
Wuhan, Hubei, 430077, China
Shenyang Anorectal Hospital
Shenyang, Liaoning, 110002, China
General Surgery, Shandong Provincial Hospital
Jinan, Shandong, 250022, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117, China
Related Publications (1)
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.
PMID: 17143848RESULT
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Head of General Surgery
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 28, 2013
Record last verified: 2013-11