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

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: Colorectal Cancer
• Intervention / Treatment: Other: Wait list time

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

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

How is the study designed?

Number of groups / cohorts

4

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	5 years

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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