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NCT04788368 Clinical Trial

TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland

Rectal Neoplasms Clinical Trial

— TRECA  

Official title:
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04788368
Other study ID # TRECA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2021

Study information
Verified date November 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Rectal cancer resected by local resection Exclusion Criteria: - All other types of resection or treatment for rectal cancer

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical resection
Surgical resection with either of the above mentioned techniques

Locations
Country Name City State
Sweden Sahlgrenska University Hospital 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 Pathological clear margins Pathological examination of the specimen showing free margins 1-2 months after surgery
Primary Complications after surgery Complications graded using the Clavien Dindo classification 90 days after surgery
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