Rectal CancerNCT05108753
Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China
An observational study of Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 2 sites in China.
Trial summary
Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Procedure/Surgery
- How many people
- 175 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2017to 30 Sep 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: rectal cancer
Who may be able to join
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of rectal carcinoma
- Undergoing transanal total mesorectal excision
Who cannot join
- Pregnant or lactating women
- Synchronous rectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Emergency procedure
Trial locations and contacts
2 sites in 1 country.
China2 sites
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020
Shanghai Minimally Invasive Surgery Center
Shanghai
About this study
Official title: Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China: Retrospective Study of the First Twenty-five Cases in Seven High-volume Centers
Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.
- Conditions
- Rectal Cancer
- Being tested
- Procedure/Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/SurgeryOther
Transanal Total Mesorectal Excision
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 5 patients underwent TaTME under proctoring Receives: Other: Procedure/Surgery | |
| Group 2 | the first 10 patients underwent TaTME without proctoring Receives: Other: Procedure/Surgery | |
| Group 3 | the second 10 patients underwent TaTME without proctoring Receives: Other: Procedure/Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of anastomotic leakage
according to the International Rectal Cancer Study Group
Measured: thirty days after surgery
Secondary outcomes (3)
incidence of Defecation disorders
A Wexner score >10 indicated the existence of defecation dysfunction
Measured: 6 months after surgery
incidence of positive distal resection margin
A positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM
Measured: 30 days after surgery
incidence of positivecircumferential resection margin
The positive circumferential resection margin (CRM) was defined as the presence of tumor cells within 1 mm from the CRM
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 posted5 Nov 2021
- Study start1 Feb 2017
- Primary completion30 Apr 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108753
- Sponsor's protocol ID
- MISC-TaTME-RETRO
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China: Retrospective Study of the First Twenty-five Cases in Seven High-volume Centers
- ClinicalTrials.gov ID
- NCT05108753
- Acronym / sponsor ID
- MISC-TaTME-RETRO
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Nov 2021 (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.
Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Procedure/Surgery5 patients underwent TaTME under proctoring |
| Group 2 | – | Other: Procedure/Surgerythe first 10 patients underwent TaTME without proctoring |
| Group 3 | – | Other: Procedure/Surgerythe second 10 patients underwent TaTME without proctoring |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- rectal cancer
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of rectal carcinoma
- Undergoing transanal total mesorectal excision
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Synchronous rectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Emergency procedure
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 |
|---|---|---|
| Procedure/SurgeryTransanal Total Mesorectal Excision | Other | Group 1, Group 2, Group 3 |
Primary outcome
incidence of anastomotic leakage
Time frame: thirty days after surgery
according to the International Rectal Cancer Study Group
3 secondary outcomes
incidence of Defecation disorders
Time frame: 6 months after surgery
incidence of positive distal resection margin
Time frame: 30 days after surgery
incidence of positivecircumferential resection margin
Time frame: 30 days after 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 5 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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, run by Shanghai Minimally Invasive Surgery Center at 2 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 5 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
incidence of anastomotic leakage (time frame: thirty days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2021.