Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment (Tidop)

We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Time to treatment

• Study Type: Observational
• Enrollment (Actual): 40000

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41132
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients registered with a diagnosis of colorectal cancer in Sweden between 2008-2016

Description

Inclusion Criteria:

• Diagnosed with colorectal cancer 2008-2016 in Sweden

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal cancer patients; Patients diagnosed with colonrectal cancer between 2008-2016	Other: Time to treatment; Treatment before or after 4 weeks after diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Hospital stay	90 days
Re-operations within 3 months	Surgical procedures registered within 3 months after the procedure date	90 days
Re-admissions within 3 months	Readmissions registered within 3 months after the procedure date	90 days
Radical surgery	Defined as R0 resection	90 days

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ACTUAL): July 15, 2021
• Study Completion (ACTUAL): September 15, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (ACTUAL): September 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

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: Tidop

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data is extracted from CRCBaSe, (ColoRectal Cancer Data Base) a combination of several registries in Sweden and thus the sharing option will be decided by that work group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No