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

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.

Conditions

• Rectal Cancer
• Rectum Neoplasm

Interventions

PROCEDURE

Transanal local excision

Transanal full thickness local excision

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Complejo Hospitalario Universitario de Vigo

  collaborator OTHER

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  lead OTHER

Principal Investigators

• Rodrigo Tovar Perez, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

• Carlos Cerdán Santacruz, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

• Óscar Cano Valderrama, PhD · Complejo Hospitalario Universitario de Vigo

• Francisco Jiménez Escovar, PhD · Hospital de Galdakao Usansolo

• Blas Flor Lorente, PhD · Hospital Politécnico Universitario la Fe

• Javier García Septiem, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

• Rodrigo Oliva Pérez, PhD · Hospital Alemão Oswaldo Cruz

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-13

Primary Completion

2027-03-01

Completion

2027-05-01

Countries

• Spain

Study Locations