Rectal CancerNCT03416699
Chinese TaTME Registry Collaborative
An observational study of Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2017to 15 Nov 2021
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with middle-lower rectal neoplasms who are suitable and willing to accept TaTME procedure and also agree with the registry
Who may be able to join
- malignant or benign neoplasms of the rectum
- the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- tolerable to surgery
- be able to understand and willing to participate in this registry with signature
Who cannot join
- patients requiring emergency surgery such as obstruction，perforation and bleeding
- tumor involving adjacent organs, anal sphincter, or levator ani muscle
- muti-focal colorectal cancer
- preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
- history of inflammatory bowel disease or familial adenomatous polyposis
- can not tolerate the surgery
Show all 10Show fewer
- history of serious mental illness
- pregnancy or lactating women
- preoperative uncontrolled infection
- the researchers believe the patients should not enrolled in
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
Hongwei Yao, M.D., +8613611015609, yaohongwei@medmail.com.cn
About this study
Official title: Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.
- Conditions
- Rectal Cancer
- Keywords
- Transnal Total Mesorectal Excision, Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of circumferential resection margin (CRM) of the specimens
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
Measured: 10 days after surgery
The grade score of the specimens integrity
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
Measured: 10 days after surgery
Secondary outcomes (6)
local recurrence rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3 years after surgery
disease free survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
overall survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
the incidence of postoperative complications
the incidence of postoperative complications after transanal total mesorectal excision.
Measured: 30 days after surgery
the severity of postoperative complication assessed by Clavien Dindo grade
the severity of postoperative complication after transanal total mesorectal assessed by Clavien Dindo grade
Measured: 30 days after surgery
the grade of anastomotic leakage
the grade of anastomotic leakage for patients who develop anastomotic leakage after transanal total mesorectal excision assessed by the grading system proposed by International Study Group of Rectal Cancer (ISREC).
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start15 Nov 2017
- Primary completion15 Nov 2018 (estimated)
- Study completion15 Nov 2021 (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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital, Huashan Hospital, Dongguan Kanghua Hospital, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Nanchong Central Hospital, Sino-Japanese Friendship Hospital of Jilin University, Koo Foundation Sun Yat-Sen Cancer Center, Shangdong Linzi District People's Hospital, Peking University People's Hospital, Nantong University, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, The First Affiliated Hospital of Nanchang University, Nanjing PLA General Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Xiamen University, Sichuang Zigong First People's Hospital, Beijing Chao Yang Hospital, Peking University Third Hospital, Jinhua Central Hospital, Beijing Hospital, The First Affiliated Hospital of Zhengzhou University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University General Hospital, LanZhou University, Chinese PLA General Hospital, Cancer Hospital of Guizhou Province, First Hospital of China Medical University, First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416699
- Sponsor's protocol ID
- CTRC
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Q, Yang X, Teng Q, Guo Q, Qin L, Lv Z, Zhou D, Ren M. Reasonable Collocation of Two Different Functional 3D Laparoscopes May Improve the Efficiency of Transanal Total Mesorectal Excision Surgery Using a Synchronous Two-Team Approach? J Laparoendosc Adv Surg Tech A. 2023 Feb;33(2):194-199. doi: 10.1089/lap.2022.0326. Epub 2022 Jul 22.
PubMed 35867023
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Transanal Total Mesorectal Excision Registry Collaborative: A Nationwide Registry Study
- ClinicalTrials.gov ID
- NCT03416699
- Acronym / sponsor ID
- CTRC
- Conditions
- Rectal Cancer
- Keywords
- Transnal Total Mesorectal Excision, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital, Huashan Hospital, Dongguan Kanghua Hospital, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Nanchong Central Hospital, Sino-Japanese Friendship Hospital of Jilin University, Koo Foundation Sun Yat-Sen Cancer Center, Shangdong Linzi District People's Hospital, Peking University People's Hospital, Nantong University, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, The First Affiliated Hospital of Nanchang University, Nanjing PLA General Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Xiamen University, Sichuang Zigong First People's Hospital, Beijing Chao Yang Hospital, Peking University Third Hospital, Jinhua Central Hospital, Beijing Hospital, The First Affiliated Hospital of Zhengzhou University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University General Hospital, LanZhou University, Chinese PLA General Hospital, Cancer Hospital of Guizhou Province, First Hospital of China Medical University, First Affiliated Hospital of Chongqing Medical University
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 31 Jan 2018 (actual)
- 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.
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with middle-lower rectal neoplasms who are suitable and willing to accept TaTME procedure and also agree with the registry
Key inclusion criteria (4 listed)
- malignant or benign neoplasms of the rectum
- the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- tolerable to surgery
- be able to understand and willing to participate in this registry with signature
Key exclusion criteria (10 listed)
- patients requiring emergency surgery such as obstruction，perforation and bleeding
- tumor involving adjacent organs, anal sphincter, or levator ani muscle
- muti-focal colorectal cancer
- preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
- history of inflammatory bowel disease or familial adenomatous polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive rate of circumferential resection margin (CRM) of the specimens
Time frame: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
The grade score of the specimens integrity
Time frame: 10 days after surgery
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
6 secondary outcomes
local recurrence rate
Time frame: 3 years after surgery
disease free survival rate
Time frame: 3-year after surgery
overall survival rate
Time frame: 3-year after surgery
the incidence of postoperative complications
Time frame: 30 days after surgery
the severity of postoperative complication assessed by Clavien Dindo grade
Time frame: 30 days after surgery
the grade of anastomotic leakage
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 35867023Li Q, Yang X, Teng Q, Guo Q, Qin L, Lv Z, Zhou D, Ren M. Reasonable Collocation of Two Different Functional 3D Laparoscopes May Improve the Efficiency of Transanal Total Mesorectal Excision Surgery Using a Synchronous Two-Team Approach? J Laparoendosc Adv Surg Tech A. 2023 Feb;33(2):194-199. doi: 10.1089/lap.2022.0326. Epub 2022 Jul 22.
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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.
1 site 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, run by Beijing Friendship Hospital at 1 site 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 10 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hongwei Yao, M.D. (+8613611015609, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of circumferential resection margin (CRM) of the specimens (time frame: 10 days after surgery). The study lists 2 primary outcomes in all. 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 NCT03416699, 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 31 Jan 2018.