Rectal CancerNCT05682794
Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort
An observational study of Rectal Cancer, run by Sun Yat-sen University.
Trial summary
The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- transanal total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 2,502 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2022
- 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: Low-mid rectal cancer within Stage III.
Who may be able to join
- Age between 18 and 80 years old
- Confirmed rectal adenocarcinoma cancer pathologically
- Tumor location ≦ 12 cm from the anal margin
- Willing and able to provide written informed consent for participation in this study
Who cannot join
- Distant metastasis before surgery
- More than one colorectal tumor at diagnosis
- Familial adenomatous polyposis
- Recurrent rectal cancer
- Undergo transanal minimally invasive surgery
- Undergo palliative treatment
- Undergo emergency surgery
About this study
Official title: Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort
The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.
Read the detailed description
Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.
- Conditions
- Rectal Cancer
- Being tested
- transanal total mesorectal excision
- Keywords
- Rectal cancer, taTME, Local recurrence
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal total mesorectal excisionProcedure or surgery
Also called laparoscopic total mesorectal excision
transanal TME
| Study group | Role | What they receive |
|---|---|---|
| taTME | patients who underwent transanal total mesorectal excision Receives: Procedure: transanal total mesorectal excision | |
| laTME | patients who underwent laparoscopic total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: 5 years after the surgery
disease-free survival ratev
Measured: 5 years after the surgery
Secondary outcomes (5)
Local recurrence rate
Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis
Measured: 3 years after the surgery
Cancer special survival rate
Cancer special survival was defined as the time from the date of primary rectal cancer resection to the date of death caused by rectal cancer.
Measured: 5 years after the surgery
Quality of the mesorectum specimen
The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete
Measured: 30 days after the surgery
CRM status
The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.
Measured: 30 days after the surgery
DRM status
The DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startJan 2014
- Primary completionOct 2022
- Study completionOct 2022
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 Sun Yat-sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Liang Kang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682794
- Sponsor's protocol ID
- GIHSYSU-32
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data can be obtained with a proper request.
Publications
Li Z, Liu H, Luo S, Hou Y, Zhou Y, Zheng X, Zhang X, Huang L, Zeng Z, Kang L. Long-term oncological outcomes of transanal versus laparoscopic total mesorectal excision for mid-low rectal cancer: a retrospective analysis of 2502 patients. Int J Surg. 2024 Mar 1;110(3):1611-1619. doi: 10.1097/JS9.0000000000000992.
PubMed 38091943
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort
- ClinicalTrials.gov ID
- NCT05682794
- Acronym / sponsor ID
- GIHSYSU-32
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, taTME, Local recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,502 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 12 Jan 2023 (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.
The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.
Detailed description
Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taTME | – | Procedure: transanal total mesorectal excisionpatients who underwent transanal total mesorectal excision |
| laTME | – | –patients who underwent laparoscopic total mesorectal excision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low-mid rectal cancer within Stage III.
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old
- Confirmed rectal adenocarcinoma cancer pathologically
- Tumor location ≦ 12 cm from the anal margin
- Willing and able to provide written informed consent for participation in this study
Key exclusion criteria (7 listed)
- Distant metastasis before surgery
- More than one colorectal tumor at diagnosis
- Familial adenomatous polyposis
- Recurrent rectal cancer
- Undergo transanal minimally invasive surgery
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 |
|---|---|---|
| transanal total mesorectal excisionAlso: laparoscopic total mesorectal excisiontransanal TME | Procedure or surgery | taTME |
Primary outcome
Overall survival rate
Time frame: 5 years after the surgery
disease-free survival ratev
Time frame: 5 years after the surgery
5 secondary outcomes
Local recurrence rate
Time frame: 3 years after the surgery
Cancer special survival rate
Time frame: 5 years after the surgery
Quality of the mesorectum specimen
Time frame: 30 days after the surgery
CRM status
Time frame: 30 days after the surgery
DRM status
Time frame: 30 days after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38091943Li Z, Liu H, Luo S, Hou Y, Zhou Y, Zheng X, Zhang X, Huang L, Zeng Z, Kang L. Long-term oncological outcomes of transanal versus laparoscopic total mesorectal excision for mid-low rectal cancer: a retrospective analysis of 2502 patients. Int J Surg. 2024 Mar 1;110(3):1611-1619. doi: 10.1097/JS9.0000000000000992.
- Individual participant dataSharing planned: Undecided. The data can be obtained with a proper request.
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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.
Liang Kang principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Sun Yat-sen University.
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: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 5 years after the 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 NCT05682794, 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 12 Jan 2023.