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RECRUITING
NCT05927584

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

View on ClinicalTrials.gov

Summary

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE). A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure. The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer. The main question it aims to answer are: • How frequently does LE allow for rectum preservation? Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

Official title: Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

145

Start Date

2024-05-13

Completion Date

2027-05-01

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

PROCEDURE

Transanal local excision

Transanal full thickness local excision

Locations (1)

Hospital Universitario de la Princesa

Madrid, Spain