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

NCT04788368 | Completed

• 1 other identifier: TRECA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Patients treated with TEM - transanala microsurgery

Early rectal cancer treated with TEM - full thickness resection

Procedure: Surgical resection

Patients treated with ESD

Early rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection

Procedure: Surgical resection

Patients treated with EMR

Early rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

Surgical resection with either of the above mentioned techniques

Patients treated with EMR; Patients treated with ESD; Patients treated with TEM - transanala microsurgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with rectal cancer treated with a local resection

You may qualify if:

• Rectal cancer resected by local resection

You may not qualify if:

• All other types of resection or treatment for rectal cancer

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)