Low Rectal CancerTAMISNCT02488577
Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer
A study testing Transanal minimally invasive total mesorectal excision and transanal minimally invasive locoregional resection in people with Low Rectal Cancer, run by Osama Mohammad Ali ElDamshety.
Trial summary
Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Rectal Cancer
- What is being tested?
- Transanal minimally invasive total mesorectal excision and transanal minimally invasive locoregional resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- T2 N0 low rectal cancer
Who cannot join
- patients unfit for laparoscopic resection
- Unwilling to share in the study
About this study
Official title: Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study
Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.
- Conditions
- Low Rectal Cancer
- Being tested
- Transanal minimally invasive total mesorectal excision, transanal minimally invasive locoregional resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal minimally invasive total mesorectal excisionProcedure or surgery
transanal minimally invasive locoregional resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TAMIS TME | Active comparator | T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision. Receives: Procedure: Transanal minimally invasive total mesorectal excision |
| TAMIS-Local | Active comparator | T2 N0 Cases which will undergo transanal minimally invasive locoregional resection. Receives: Procedure: transanal minimally invasive locoregional resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall percent of postoperative complications.
the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.
Measured: 30 days
Secondary outcomes (2)
Hospital stay
Number of Days starting from the admission till discharge
Measured: 30 days
Recurrence.
number of local and distant recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osama Mohammad Ali ElDamshety
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osama Mohammad Ali ElDamshety, Mansoura University
- Investigators
- Sherif Kotb, M.D., PhD., Study director, Professor of surgical oncology Mansoura universityOsama Eldamshety, PhD, Principal investigator, surgical oncology Mansoura universityAdel Fathi, M.D., Principal investigator, surgical oncology Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488577
- Sponsor's protocol ID
- MISS-TRICKR2
- Acronym
- TAMIS
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2015
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study
- ClinicalTrials.gov ID
- NCT02488577
- Acronym / sponsor ID
- TAMIS / MISS-TRICKR2
- Conditions
- Low Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Osama Mohammad Ali ElDamshetyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 2 Jul 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.
Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAMIS TME | Active comparator | Procedure: Transanal minimally invasive total mesorectal excisionT2 N0 Cases which undergo transanal minimally invasive total mesorectal excision. |
| TAMIS-Local | Active comparator | Procedure: transanal minimally invasive locoregional resectionT2 N0 Cases which will undergo transanal minimally invasive locoregional resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- T2 N0 low rectal cancer
Key exclusion criteria (2 listed)
- patients unfit for laparoscopic resection
- Unwilling to share in the study
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 minimally invasive total mesorectal excision | Procedure or surgery | TAMIS TME |
| transanal minimally invasive locoregional resection | Procedure or surgery | TAMIS-Local |
Primary outcome
Overall percent of postoperative complications.
Time frame: 30 days
the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.
2 secondary outcomes
Hospital stay
Time frame: 30 days
Recurrence.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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.
Sherif Kotb, M.D., PhD. study director
Professor of surgical oncology Mansoura university
Osama Eldamshety, PhD principal investigator
surgical oncology Mansoura university
Adel Fathi, M.D. principal investigator
surgical oncology Mansoura university
Questions about this trial
What is this clinical trial studying?
A study testing Transanal minimally invasive total mesorectal excision and transanal minimally invasive locoregional resection in people with Low Rectal Cancer, run by Osama Mohammad Ali ElDamshety.
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 1 inclusion and 2 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Overall percent of postoperative complications. (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 12 Sep 2018.