Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
August 5, 2016 updated by: Leonardo Alfonso Bustamante, University of Sao Paulo
Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- T4 Colorectal cancer -
Exclusion Criteria:
- Non primary Colorectal cancer -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Multiviceral resection colorectal cancer
Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
|
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: 3 years
|
diseases free survival
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence
Time Frame: 3 years
|
months after local or systemic recurrence for colorectal cancer
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
August 1, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 8, 2016
Study Record Updates
Last Update Posted (Estimate)
August 8, 2016
Last Update Submitted That Met QC Criteria
August 5, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07081980
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.