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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04406974
Other study ID # Lokalrecidiv i VGR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2024

Study information

Verified date December 2023
Source Sahlgrenska University Hospital, Sweden
Contact Eva Angenete, MD. PhD
Phone 0760514441
Email eva.angenete@vgregion.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 1, 2024
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Locally advanced rectal cancer - Local recurrence for colorectal cancer - Curative treatment for colorectal cancer Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival after local recurrence 3 years
Primary Risk factors for local recurrence Preoperative data, about 1 month prior surgery
Primary Complications after urinary reconstruction surgery for locally advanced cancer 90 days
Primary Patient experiences after local recurrence Indepth interviews with patients with local recurrence 3 years postopeartively after local recurrence
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