Rectal CancerNCT05933785
the Value of Transanal Endoscopic ISR
An observational study of Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 2 sites in China.
Trial summary
The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. 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 endoscopic ISR
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jan 2018to 30 May 2023
- 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: patient with low and ultra-low 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
- preoperative stage as (y) cT1-3N0-2M0
- lower margin of the tumor less than 5cm from the anus
- tumor diameter ≤5cm
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, 200025
Shanghai Minimally Invasive Surgery Center
Shanghai
About this study
Official title: The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer
The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- transanal endoscopic ISR
- 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 endoscopic ISRProcedure or surgery
perform ISR using laparoscopy through transanal port
| Study group | Role | What they receive |
|---|---|---|
| transanal endoscopic ISR | Not described Receives: Procedure: transanal endoscopic ISR | |
| traditional ISR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
anal preservation rate
No conversion to APR and closure was closed within 1 year after surgery
Measured: 1 year after sugery
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start2 Jan 2018
- Primary completion30 Jun 2021
- Study completion30 May 2023
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
- 260 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
- NCT05933785
- Sponsor's protocol ID
- taE-ISR
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2023
- Last updated
- 7 Mar 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT05933785
- Acronym / sponsor ID
- taE-ISR
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 Jul 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 Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal endoscopic ISR | – | Procedure: transanal endoscopic ISR |
| traditional ISR | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with low and ultra-low rectal cancer
Key inclusion criteria (6 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of rectal carcinoma
- preoperative stage as (y) cT1-3N0-2M0
- lower margin of the tumor less than 5cm from the anus
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 |
|---|---|---|
| transanal endoscopic ISRperform ISR using laparoscopy through transanal port | Procedure or surgery | transanal endoscopic ISR |
Primary outcome
anal preservation rate
Time frame: 1 year after sugery
No conversion to APR and closure was closed within 1 year after surgery
2 secondary outcomes
incidence of Defecation disorders
Time frame: 6 months after surgery
incidence of positive distal 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 7 Mar 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.
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 6 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 7 Mar 2024. 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?
anal preservation rate (time frame: 1 year after sugery). 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 7 Mar 2024.