Rectal CancerNCT01938027
The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Transanal total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging, (T1 or T2 or T3) with N0M0
- Rectal cancer located 4-12 cm from the anal verge
- ECOG performance status 2 or less
Who cannot join
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
- History of prior colorectal cancer or inflammatory bowel disease
- BMI > 30
- T3 rectal cancer not treated preoperatively with full-course chemoradiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Read the detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
- Conditions
- Rectal Cancer
- Being tested
- Transanal total mesorectal excision
- Keywords
- Rectal Neoplasms, Colorectal Neoplasms, transanal surgery
- Medical subject headings
- Rectal Neoplasms, Colorectal 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
Laparoscopy-assisted transanal total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Laparoscopy-assisted transanal total mesorectal excision Receives: Procedure: Transanal total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Mesorectal Excision(TME) quality
The quality of the mesorectum was determined using pathology reports and scored using three grades:
- Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
- Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
- Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
Measured: 1-5 years
Secondary outcomes (1)
30-day postoperative complications, No. of harvested LN
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jae Hwan Oh, National Cancer Center, Korea
- Investigators
- Jae Hwan Oh, MD, PHD, Principal investigator, NCC,Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938027
- Sponsor's protocol ID
- NCC-TAME
- Other IDs
- NCC-1210170
- Status last verified
- Mar 2015
- First submitted
- 4 Sep 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh JH, Park SC, Kim MJ, Park BK, Hyun JH, Chang HJ, Han KS, Sohn DK. Feasibility of transanal endoscopic total mesorectal excision for rectal cancer: results of a pilot study. Ann Surg Treat Res. 2016 Oct;91(4):187-194. doi: 10.4174/astr.2016.91.4.187. Epub 2016 Sep 30.
PubMed 27757396
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT01938027
- Acronym / sponsor ID
- NCC-TAME
- Conditions
- Rectal Cancer
- Keywords
- Rectal Neoplasms, Colorectal Neoplasms, transanal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Sep 2013 (estimated)
- 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 is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Procedure: Transanal total mesorectal excisionLaparoscopy-assisted transanal total mesorectal excision |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging, (T1 or T2 or T3) with N0M0
- Rectal cancer located 4-12 cm from the anal verge
- ECOG performance status 2 or less
Key exclusion criteria (8 listed)
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
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 excisionLaparoscopy-assisted transanal total mesorectal excision | Procedure or surgery | Transanal total mesorectal excision |
Primary outcome
Total Mesorectal Excision(TME) quality
Time frame: 1-5 years
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
1 secondary outcome
30-day postoperative complications, No. of harvested LN
Time frame: 1-5 years
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 26 Mar 2015.
- Derived from this study: PubMed 27757396Oh JH, Park SC, Kim MJ, Park BK, Hyun JH, Chang HJ, Han KS, Sohn DK. Feasibility of transanal endoscopic total mesorectal excision for rectal cancer: results of a pilot study. Ann Surg Treat Res. 2016 Oct;91(4):187-194. doi: 10.4174/astr.2016.91.4.187. Epub 2016 Sep 30.
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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.
Jae Hwan Oh, MD, PHD principal investigator
NCC,Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 5 inclusion and 8 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 26 Mar 2015. 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 South Korea. 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?
Total Mesorectal Excision(TME) quality (time frame: 1-5 years). 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 NCT01938027, 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 26 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.