Rectal CancerNCT06380855
Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)
An observational study of Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Flexible colonoscope assisted hybrid transanal total mesorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2022to 24 Aug 2025
- 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: All patients suitable for transanal endoscopic surgery
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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Liang Kang, MD, PhD, 008613602886833, eonkang@163.com
About this study
The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury.
Read the detailed description
Endoscopic technique has become an indispensable part of Natural orifice transluminal endoscopic surgery (NOTES). However, the upper gastrointestinal tract is easy to cause severe leakage complications, which mainly limits the application of endoscopy in rectum. Herein, investigators propose purse suture closing distal rectum and full-layer incision of the rectal wall using flexible endoscopic from anal to assist in hybrid transanal total mesorectal resection (taTME).Further reduce the damage of anus caused by taTME.
- Conditions
- Rectal Cancer
- Being tested
- Flexible colonoscope assisted hybrid transanal total mesorectal resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible colonoscope assisted hybrid transanal total mesorectal resectionProcedure or surgery
Endoscopic pursestring suture (EPSS) was performed at the distance from 1cm to the inferior edge of the tumor by a double-channel flexible colonoscope. An endoloop was inserted through one channel. Meanwhile, the endoclips was inserted through the other channel one by one to fix the endoloop around the rectal wall. And then the endoloop was tightened slowly. After completing the routine lavage lumen, a full-thickness, circumferential dissection was performed by flexible colonoscope following taTME surgical principle until it converged with the laparoscopy group.
| Study group | Role | What they receive |
|---|---|---|
| Flexible colonoscope assisted taTME group | Flexible colonoscope assisted hybrid transanal total mesorectal resection (taTME) group Receives: Procedure: Flexible colonoscope assisted hybrid transanal total mesorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of operation
Whether it is necessary to switch to other surgical methods
Measured: 1 years 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 posted24 Apr 2024
- Study start24 Aug 2022
- Primary completion24 Aug 2025 (estimated)
- Study completion24 Aug 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380855
- Sponsor's protocol ID
- GIHSYSU-34
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)
- ClinicalTrials.gov ID
- NCT06380855
- Acronym / sponsor ID
- GIHSYSU-34
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 24 Aug 2025 (estimated)
- Study completion
- 24 Aug 2025 (estimated)
- First posted
- 24 Apr 2024 (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 investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury.
Detailed description
Endoscopic technique has become an indispensable part of Natural orifice transluminal endoscopic surgery (NOTES). However, the upper gastrointestinal tract is easy to cause severe leakage complications, which mainly limits the application of endoscopy in rectum. Herein, investigators propose purse suture closing distal rectum and full-layer incision of the rectal wall using flexible endoscopic from anal to assist in hybrid transanal total mesorectal resection (taTME).Further reduce the damage of anus caused by taTME.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible colonoscope assisted taTME group | – | Procedure: Flexible colonoscope assisted hybrid transanal total mesorectal resectionFlexible colonoscope assisted hybrid transanal total mesorectal resection (taTME) group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients suitable for transanal endoscopic surgery
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 |
|---|---|---|
| Flexible colonoscope assisted hybrid transanal total mesorectal resectionEndoscopic pursestring suture (EPSS) was performed at the distance from 1cm to the inferior edge of the tumor by a double-channel flexible colonoscope. An endoloop was inserted through one channel. Meanwhile, the endoclips was inserted through the other channel one by one to fix the endoloop around the rectal wall. And then the endoloop was tightened slowly. After completing the routine lavage lumen, a full-thickness, circumferential dissection was performed by flexible colonoscope following taTME surgical principle until it converged with the laparoscopy group. | Procedure or surgery | Flexible colonoscope assisted taTME group |
Primary outcome
Success rate of operation
Time frame: 1 years after the surgery
Whether it is necessary to switch to other surgical methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
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 Sun Yat-sen University 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 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 24 Apr 2024. 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 Liang Kang, MD. and Phd. (020-38455369, kangl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of operation (time frame: 1 years after the 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 24 Apr 2024.