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Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02859155
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
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
Information provided by (Responsible Party):
Leonardo Alfonso Bustamante, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date August 8, 2016
Study Start Date  ICMJE January 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
Survival [ Time Frame: 3 years ]
diseases free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
Recurrence [ Time Frame: 3 years ]
months after local or systemic recurrence for colorectal cancer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Official Title  ICMJE Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Procedure: Multivisceral en bloc resection surgery
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
Study Arms  ICMJE Multiviceral resection colorectal cancer
Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
Intervention: Procedure: Multivisceral en bloc resection surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2016)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • T4 Colorectal cancer -

Exclusion Criteria:

  • Non primary Colorectal cancer -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02859155
Other Study ID Numbers  ICMJE 07081980
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Leonardo Alfonso Bustamante, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP