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.
Patients age 18 years or older.
Histologic proof of infiltrating rectal adenocarcinoma. or
Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.
Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .
Patients younger than 18 years old.
Rectal neoplasms different from adenocarcinoma.
Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.
Any other clinical stage other than cT1N0M0 (any T>1, N+, or M+).
Adults diagnosed with early stage rectal cancer, meaning clinical TNM staging cT1N0M0, programmed to receive Local Excision as an exclusive therapy according to each center´s standard practice.
Cohort
Prospective
Transanal local excision
Procedure/SurgeryTransanal full thickness local excision
Success rate
Rate of patients with no need of Total Mesorectal Excision after follow-up
Morbidity rate
Postoperative complication rate, description, and severity according to Clavien Dindo classification
Radicality of resection
Describe the rate of margin tumor infiltration
Histological poor outcome predictor rate
Describe the rate of lymphatic, vascular and perineural invasion, histological grade, mean submucosal invasion depth
Radical rescue surgery specimen quality
Describe the quality of Total Mesorectal Excision specimen in terms of mesorectal fascia integrity
Click on the lead sponsor to view all of their trials.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
Hospital Alemão Oswaldo Cruz
Collaborator
Hospital Universitario La Fe
Collaborator
Complejo Hospitalario Universitario de Vigo
Collaborator
