Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.

June 12, 2020 updated by: Stephanie Garcia Botello, Fundación para la Investigación del Hospital Clínico de Valencia

Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.: A COHORT STUDY

This work is an original clinical research article describing the relationship between wait list tome for colorectal cancer patients and long-term survival. These findings are particularly relevant for management of surgical wait lists during crisis such as the Covid-19 pandemic. The lack of a relationship between wait list time and disease free survival and tendency for improved survival in the 4-6 week imply some colorectal cancer operations can be safely delayed during times of limited resources.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Surgical wait list time is a major problem in many health-care systems and its influence on survival is unclear. The aim of this study is to assess the impact of the wait list time on long term disease-free survival in patients scheduled for colorectal cancer resection.

Materials and Methods A prospective, single center study was carried out in patients with stage I-III colorectal cancer scheduled for surgery between 2012-2017 at a Colorectal Surgery Unit of a tertiary care center. Wait list time was defined as the time from completion of diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks. The outcome variables were 2- and 5-year disease free survival. Screening for disease progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography scan. Data was collected prospectively and subsequently analyzed.

Study Type

Observational

Enrollment (Actual)

602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who had American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas were selected, with "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

Description

Inclusion Criteria:

  • American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas
  • With "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

Exclusion Criteria:

  • Emergency surgery,
  • More than one primary site,
  • Synchronous metastasis or peritoneal carcinomatosis at the time of surgery
  • If they received neoadjuvant chemoradiotherapy
  • If they had a local transanal excision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wait list time 0-2 weeks
Other: Wait list time
Wait list time 2-4 weeks
Other: Wait list time
Wait list time 4-6 weeks
Other: Wait list time
Wait list time > 6 weeks
Other: Wait list time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (ACTUAL)

June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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