Colorectal NeoplasmLATANCT02324556
A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial
An observational study of Colorectal Neoplasm, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed. Primary endpoint is clinical and pathologic examination of the specimen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasm
- How many people
- 6 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2015to Jun 2015
- 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: Rectal cancer possible to operate with an anterior resection.
Who may be able to join
- presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
- possible to operate with laparoscopic technique
- possible to operate in regard to concomitant disease
- giving informed consent to participate
Who cannot join
- -Participation in other trials in conflict with the protocol and end-points the LATA-trial
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
NU-sjukvården
Trollhättan
About this study
Official title: A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial
All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.
Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.
Read the detailed description
The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.
It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.
- Conditions
- Colorectal Neoplasm
- Keywords
- Rectal Cancer, Surgery, Laparoscopy
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic total mesorectal excision | Patients operated with laparoscopic total mesorectal surgery for rectal cancer | |
| transanal total mesorectal excision | Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of specimens with grade I specimen according to Quirke
Comparison with control group
Measured: 4 weeks postoperatively
Secondary outcomes (3)
Conversion rate
Measured: day of surgery
Re-admission
Measured: 30 days
Postoperative complications scored according to Clavien-Dindo within the first 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Patients are currently being operated in the robot instead due to logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, M.D., Ph.D., Principal investigator, Sahlgrenska Universitetssjukhuset/Östra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324556
- Sponsor's protocol ID
- LATA
- Acronym
- LATA
- Status last verified
- Apr 2020
- First submitted
- 27 Nov 2014
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial
- ClinicalTrials.gov ID
- NCT02324556
- Acronym / sponsor ID
- LATA / LATA
- Conditions
- Colorectal Neoplasm
- Keywords
- Rectal Cancer, Surgery, Laparoscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patients are currently being operated in the robot instead due to logistics
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Dec 2014 (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.
All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.
Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.
Detailed description
The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.
It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic total mesorectal excision | – | –Patients operated with laparoscopic total mesorectal surgery for rectal cancer |
| transanal total mesorectal excision | – | –Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rectal cancer possible to operate with an anterior resection.
Key inclusion criteria (4 listed)
- presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
- possible to operate with laparoscopic technique
- possible to operate in regard to concomitant disease
- giving informed consent to participate
Key exclusion criteria (1 listed)
- -Participation in other trials in conflict with the protocol and end-points the LATA-trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of specimens with grade I specimen according to Quirke
Time frame: 4 weeks postoperatively
Comparison with control group
3 secondary outcomes
Conversion rate
Time frame: day of surgery
Re-admission
Time frame: 30 days
Postoperative complications scored according to Clavien-Dindo within the first 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Patients are currently being operated in the robot instead due to logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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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.
Eva Angenete, M.D., Ph.D. principal investigator
Sahlgrenska Universitetssjukhuset/Östra
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 Colorectal Neoplasm, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 1 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: stopped early, as of the sponsor's last update on 28 Apr 2020. 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 Sweden. 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 was stopped early (reason given: Patients are currently being operated in the robot instead due to logistics). Results are not available in the source record.
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?
Number of specimens with grade I specimen according to Quirke (time frame: 4 weeks postoperatively). 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 28 Apr 2020.