NCT02859155

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

5.1 years

First QC Date

August 1, 2016

Last Update Submit

August 5, 2016

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Survival

    diseases free survival

    3 years

Secondary Outcomes (1)

  • Recurrence

    3 years

Study Arms (1)

Multiviceral resection colorectal cancer

OTHER

Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer

Procedure: Multivisceral en bloc resection surgery

Interventions

Multivisceral en bloc resection surgeryPROCEDURE

Multivisceral en bloc resection for colorectal cancer in advance patients (T4)

Multiviceral resection colorectal cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T4 Colorectal cancer -

You may not qualify if:

  • Non primary Colorectal cancer -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28591336DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 8, 2016

Study Start

January 1, 2009

Primary Completion

February 1, 2014

Study Completion

April 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share