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Trial record 8 of 1002 for:    colon cancer AND resection

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

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Multivisceral en bloc resection surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Study Start Date : January 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Multiviceral resection colorectal cancer
Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
Procedure: Multivisceral en bloc resection surgery
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)




Primary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]
    diseases free survival


Secondary Outcome Measures :
  1. Recurrence [ Time Frame: 3 years ]
    months after local or systemic recurrence for colorectal cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T4 Colorectal cancer -

Exclusion Criteria:

  • Non primary Colorectal cancer -

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leonardo Alfonso Bustamante, M.D, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02859155     History of Changes
Other Study ID Numbers: 07081980
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases