Rectal CancerNCT00949273
Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer
An observational study of Rectal Cancer and Treatment, run by Beijing Chao Yang Hospital at 7 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Treatment, Postoperative Complications
- What is being tested?
- cylindrical abdominoperineal resection
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 7 sitesChina
- Study dates
- Jul 2009to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients with rectal cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Luhe Hospital
Beijing, Beijing Municipality, 100000
Jian Hua Cai, M.D., caijianhua10020@163.com
Jian Hua Cai, M.D.
- Recruiting
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
Jia Gang Han, M.D., 86-013522867841, hjg512@yahoo.com.cn
Zhen Jun Wang, M.D.
- Recruiting
General Surgery, Shandong Provincial Hospital
Jinan, Shandong, 250022
Yong Dai, M.D., 86-013708933989
Yong Dai, M.D.
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Heng Ma, M.D., 86-013954191086
Heng Ma, M.D.
- Recruiting
Shenyang Anorectal Hospital
Shenyang, Liaoning, 110002
Xian Dong Zeng, M.D., zeng_xiandong@sina.com
Xian Dong Zeng, M.D.
- Recruiting
Zhongnan Hospital, Wuhan University
Wuhan, Hubei, 430077
Qun Qian, M.D., 86-013517110773
Qun Qian, M.D.
- Recruiting
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003
Wei Tang Yuan, M.D., 86-013673384555
Wei Tang Yuan, M.D.
About this study
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
The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer
Read the 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.
- Conditions
- Rectal Cancer, Treatment, Postoperative Complications, Neoplasm Recurrence, Local, Survival Rate
- Being tested
- cylindrical abdominoperineal resection
- Keywords
- cylindrical abdominoperineal resection, rectal cancer, acellular dermal matrix, pelvic reconstruction, circumferential resection margin, overall survival
- Medical subject headings
- Rectal Neoplasms, Postoperative Complications, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cylindrical abdominoperineal resectionProcedure or surgery
Also called Ruinuo
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| cylindrical abdominoperineal resection | patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer Receives: Procedure: cylindrical abdominoperineal resection | |
| abdominoperineal resection | patients underwent conventional abdominoperineal resection for advanced very low rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Measured: 08/01/2011
Secondary outcomes (1)
3-years overall survival
Measured: 08/01/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Shandong Cancer Hospital and Institute, The First Affiliated Hospital of Zhengzhou University, Wuhan University, Shenyang Anorectal Hospital, Beijing Luhe Hospital
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Zhen Jun Wang, M.D., Study chair, Beijing Chao Yang HospitalYong Dai, M.D., Principal investigator, Shandong Provincial HospitalHeng Ma, M.D., Principal investigator, Shandong Cancer Hospital and InstituteQun Qian, M.D., Principal investigator, Zhong Nan Hospital, Wuhan UniversityXian Dong Zeng, M.D., Principal investigator, Shenyang Anorectal HospitalJian Hua Cai, M.D., Principal investigator, Beijing Luhe HospitalWei Tang Yuan, M.D., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949273
- Sponsor's protocol ID
- CAPR0668
- Status last verified
- Nov 2013
- First submitted
- 29 Jul 2009
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17143848
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00949273
- Acronym / sponsor ID
- CAPR0668
- Conditions
- Rectal Cancer, Treatment, Postoperative Complications, Neoplasm Recurrence, Local, Survival Rate
- Keywords
- cylindrical abdominoperineal resection, rectal cancer, acellular dermal matrix, pelvic reconstruction, circumferential resection margin, overall survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Shandong Cancer Hospital and Institute, The First Affiliated Hospital of Zhengzhou University, Wuhan University, Shenyang Anorectal Hospital, Beijing Luhe Hospital
- Study start
- Jul 2009
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cylindrical abdominoperineal resection | – | Procedure: cylindrical abdominoperineal resectionpatients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer |
| abdominoperineal resection | – | –patients underwent conventional abdominoperineal resection for advanced very low rectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with rectal cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cylindrical abdominoperineal resectionAlso: RuinuoExtended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer | Procedure or surgery | cylindrical abdominoperineal resection |
Primary outcome
postoperative complications
Time frame: 08/01/2011
1 secondary outcome
3-years overall survival
Time frame: 08/01/2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Results publication: PubMed 17143848Holm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Jun Wang, M.D. study chair
Beijing Chao Yang Hospital
Yong Dai, M.D. principal investigator
Shandong Provincial Hospital
Heng Ma, M.D. principal investigator
Shandong Cancer Hospital and Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Treatment, run by Beijing Chao Yang Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Jun Wang, M.D. (86-013601393711, wang3zj@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 08/01/2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.