Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multivisceral en bloc resection surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- T4 Colorectal cancer -
Exclusion Criteria:
- Non primary Colorectal cancer -
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multiviceral resection colorectal cancer
Arm Description
Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
Outcomes
Primary Outcome Measures
Survival
diseases free survival
Secondary Outcome Measures
Recurrence
months after local or systemic recurrence for colorectal cancer
Full Information
NCT ID
NCT02859155
First Posted
August 1, 2016
Last Updated
August 5, 2016
Sponsor
University of Sao Paulo
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
1. Study Identification
Unique Protocol Identification Number
NCT02859155
Brief Title
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Official Title
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiviceral resection colorectal cancer
Arm Type
Other
Arm Description
Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
Intervention Type
Procedure
Intervention Name(s)
Multivisceral en bloc resection surgery
Intervention Description
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
Primary Outcome Measure Information:
Title
Survival
Description
diseases free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Recurrence
Description
months after local or systemic recurrence for colorectal cancer
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T4 Colorectal cancer -
Exclusion Criteria:
Non primary Colorectal cancer -
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28591336
Citation
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.
Results Reference
derived
Learn more about this trial
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
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