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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859155
• Other study ID #: 07081980
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 5, 2016
• Start date: January 2009
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: ANVISA (NATIONAL HEALTH SURVEILLANCE AGENCY) Brazil':'
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• T4 Colorectal cancer -

Exclusion Criteria:

• Non primary Colorectal cancer -

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• Multivisceral en bloc resection surgery
Multivisceral en bloc resection for colorectal cancer in advance patients (T4)

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
University of Sao Paulo	Antonio Rocco Imperiale, CAIO SERGIO NAHAS, Carlos Frederico Sparapan Marques, Daher Cezar Chade, Dariane Sampaio Piato, Fabio Busnardo, Guilherme Cutait Cotti, Ivan Cecconello, Rodrigo Ambar Pinto, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior, William Carlos Nahas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	diseases free survival	3 years	Yes
Secondary	Recurrence	months after local or systemic recurrence for colorectal cancer	3 years	Yes