Rectal CancerTAMISNCT02626728
A Prospective Feasibility Study for TAMIS
An observational study of Rectal Cancer, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- laparoscopic assisted transanal surgery (TAMIS)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Oct 2016
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.
Who may be able to join
- rectal cancer with histological diagnosis
- tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.
- suitable for elective resection
Who cannot join
- preoperative magnetic resonance imaging (MRI) showing diameter of tumor size >6 cm
- American Society of Anesthesiologists (ASA) class IV and V
- anticipated need of intensive care unit (ICU)
- history of previous major abdominal surgery
- computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs
- obese patient with body mass index >35kg/m2
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- those, who do not understand the requirements of the protocol
- pregnancy
- more than one colorectal tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer
Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.
- Conditions
- Rectal Cancer
- Being tested
- laparoscopic assisted transanal surgery (TAMIS)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic assisted transanal surgery (TAMIS)Procedure or surgery
all patients included recieve laparoscopic assisted transanal minimally invasive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
Clavien-Dindo
Measured: 30-days
Secondary outcomes (2)
mortality
death within 30-days
Measured: 30-days
short-term oncological result
cancer-free resection margins
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionOct 2016
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
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Willaume Christoffersen, Hvidovre University Hospital
- Investigators
- Mette W Christoffersen, M.D, PhD, Study chair, Hvidovre Hospital University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626728
- Sponsor's protocol ID
- 123-TAMIS
- Acronym
- TAMIS
- Status last verified
- Nov 2016
- First submitted
- 8 Dec 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02626728
- Acronym / sponsor ID
- TAMIS / 123-TAMIS
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Dec 2015 (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.
Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.
Key inclusion criteria (3 listed)
- rectal cancer with histological diagnosis
- tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.
- suitable for elective resection
Key exclusion criteria (9 listed)
- preoperative magnetic resonance imaging (MRI) showing diameter of tumor size >6 cm
- American Society of Anesthesiologists (ASA) class IV and V
- anticipated need of intensive care unit (ICU)
- history of previous major abdominal surgery
- computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs
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 |
|---|---|---|
| laparoscopic assisted transanal surgery (TAMIS)all patients included recieve laparoscopic assisted transanal minimally invasive surgery | Procedure or surgery | – |
Primary outcome
morbidity
Time frame: 30-days
Clavien-Dindo
2 secondary outcomes
mortality
Time frame: 30-days
short-term oncological result
Time frame: 30-days
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 22 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Mette W Christoffersen, M.D, PhD study chair
Hvidovre Hospital University of Copenhagen
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 Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 9 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 22 Nov 2016. 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 Denmark. 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?
morbidity (time frame: 30-days). 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 22 Nov 2016.