NCT04406974

Brief Summary

The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

4.9 years

First QC Date

May 24, 2020

Last Update Submit

December 7, 2023

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (4)

  • Survival after local recurrence

    3 years

  • Risk factors for local recurrence

    Preoperative data, about 1 month prior surgery

  • Complications after urinary reconstruction surgery for locally advanced cancer

    90 days

  • Patient experiences after local recurrence

    Indepth interviews with patients with local recurrence

    3 years postopeartively after local recurrence

Study Arms (2)

Patients with local recurrence

Procedure: Surgery or treatment for local recurrenceProcedure: Surgery for advanced colorectal cancer

Patients with advanced colorectal cancer

Procedure: Surgery or treatment for local recurrenceProcedure: Surgery for advanced colorectal cancer

Interventions

Surgery or treatment for local recurrencePROCEDURE

Surgery or treatment for local recurrence

Patients with advanced colorectal cancerPatients with local recurrence
Surgery for advanced colorectal cancerPROCEDURE

Surgery for advanced colorectal cancer

Patients with advanced colorectal cancerPatients with local recurrence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be identified using the local Swedish Colorectal Cancer Registry. Further selection will depend on the primary outcome in substudies.

You may qualify if:

  • Locally advanced rectal cancer
  • Local recurrence for colorectal cancer
  • Curative treatment for colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surgical Procedures, OperativeTherapeutics

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eva Angenete, MD. PhD

CONTACT

0760514441eva.angenete@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 29, 2020

Study Start

January 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

SE(1)