Colorectal NeoplasmsNCT02859155
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
A study testing Multivisceral en bloc resection surgery in people with Colorectal Neoplasms, run by University of Sao Paulo.
Trial summary
Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Multivisceral en bloc resection surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T4 Colorectal cancer -
Who cannot join
- Non primary Colorectal cancer -
About this study
Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.
Read the detailed description
Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.
- Conditions
- Colorectal Neoplasms
- Being tested
- Multivisceral en bloc resection surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivisceral en bloc resection surgeryProcedure or surgery
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
| Study group | Role | What they receive |
|---|---|---|
| Multiviceral resection colorectal cancer | Other | Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer Receives: Procedure: Multivisceral en bloc resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
diseases free survival
Measured: 3 years
Secondary outcomes (1)
Recurrence
months after local or systemic recurrence for colorectal cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionFeb 2014
- Study completionApr 2016
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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- CAIO SERGIO NAHAS, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior, Carlos Frederico Sparapan Marques, Rodrigo Ambar Pinto, Antonio Rocco Imperiale, Guilherme Cutait Cotti, William Carlos Nahas, Daher Cezar Chade, Dariane Sampaio Piato, Fabio Busnardo, Ivan Cecconello
- Responsible party
- Principal investigator, Leonardo Alfonso Bustamante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859155
- Sponsor's protocol ID
- 07081980
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Nahas CSR, Nahas SC, Ribeiro-Junior U, Bustamante-Lopez L, Marques CFS, Pinto RA, Imperiale AR, Cotti GC, Nahas WC, Chade DC, Piato DS, Busnardo F, Cecconello I. Prognostic factors affecting outcomes in multivisceral en bloc resection for colorectal cancer. Clinics (Sao Paulo). 2017 May;72(5):258-264. doi: 10.6061/clinics/2017(05)01.
PubMed 28591336
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02859155
- Acronym / sponsor ID
- 07081980
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- CAIO SERGIO NAHAS, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior, Carlos Frederico Sparapan Marques, Rodrigo Ambar Pinto, Antonio Rocco Imperiale, Guilherme Cutait Cotti, William Carlos Nahas, Daher Cezar Chade, Dariane Sampaio Piato, Fabio Busnardo, Ivan Cecconello
- Study start
- Jan 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Aug 2016 (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.
Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.
Detailed description
Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiviceral resection colorectal cancer | Other | Procedure: Multivisceral en bloc resection surgeryMultiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- T4 Colorectal cancer -
Key exclusion criteria (1 listed)
- Non primary Colorectal cancer -
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 |
|---|---|---|
| Multivisceral en bloc resection surgeryMultivisceral en bloc resection for colorectal cancer in advance patients (T4) | Procedure or surgery | Multiviceral resection colorectal cancer |
Primary outcome
Survival
Time frame: 3 years
diseases free survival
1 secondary outcome
Recurrence
Time frame: 3 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 8 Aug 2016.
- Derived from this study: PubMed 28591336Nahas CSR, Nahas SC, Ribeiro-Junior U, Bustamante-Lopez L, Marques CFS, Pinto RA, Imperiale AR, Cotti GC, Nahas WC, Chade DC, Piato DS, Busnardo F, Cecconello I. Prognostic factors affecting outcomes in multivisceral en bloc resection for colorectal cancer. Clinics (Sao Paulo). 2017 May;72(5):258-264. doi: 10.6061/clinics/2017(05)01.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multivisceral en bloc resection surgery in people with Colorectal Neoplasms, run by University of Sao Paulo.
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 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: finished, as of the sponsor's last update on 8 Aug 2016. 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?
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?
Survival (time frame: 3 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 NCT02859155, 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 8 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.