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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: Surgical resection

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with rectal cancer treated with a local resection

Description

Inclusion Criteria:

• Rectal cancer resected by local resection

Exclusion Criteria:

• All other types of resection or treatment for rectal cancer

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with TEM - transanala microsurgery; Early rectal cancer treated with TEM - full thickness resection	Procedure: Surgical resection; Surgical resection with either of the above mentioned techniques
Patients treated with ESD; Early rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection	Procedure: Surgical resection; Surgical resection with either of the above mentioned techniques
Patients treated with EMR; Early rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection	Procedure: Surgical resection; Surgical resection with either of the above mentioned techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological clear margins	Pathological examination of the specimen showing free margins	1-2 months after surgery
Complications after surgery	Complications graded using the Clavien Dindo classification	90 days after surgery

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Rectal Neoplasms
• Other Study ID Numbers: TRECA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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