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Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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
Conditions
Interventions
Transanal local excision
Transanal full thickness local excision
Locations (1)
Hospital Universitario de la Princesa
Madrid, Spain