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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04788368
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Study Description
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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.

Condition or disease Intervention/treatment
Rectal Neoplasms Procedure: Surgical resection

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 2 Months
Official Title: TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pathological clear margins [ Time Frame: 1-2 months after surgery ]
    Pathological examination of the specimen showing free margins

  2. Complications after surgery [ Time Frame: 90 days after surgery ]
    Complications graded using the Clavien Dindo classification


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rectal cancer treated with a local resection
Criteria

Inclusion Criteria:

  • Rectal cancer resected by local resection

Exclusion Criteria:

  • All other types of resection or treatment for rectal cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788368


Contacts
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Contact: Eva Angenete, MD. PhD +46760514441 eva.angenete@vgregion.se
Contact: Eva Angenete 0760514441 eva.angenete@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Daniel Rydbeck, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Eva Angenete, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04788368    
Other Study ID Numbers: TRECA
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type