Description of the Safety and Functionality of a Rectoscope (P201630551)

Instituto de Investigación Hospital Universitario La Paz15 enrolled

Overview

Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon. Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Oncological Rectal Surgery

Interventions

Rectoscope (P201630551)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women over 18 years old. * Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not. * Patients who accept their participation in this study, after explaining the study details. * Patients who sign the informed consent. Exclusion Criteria: * Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer. * Patients who do not accept their participation in this study.

Outcomes

Primary Outcomes

Number of adverse events related to use of the device.

Safety. Clavien-Dindo classification will be used.

Time frame: at immediate postoperative period

Evaluation of functionality

Categorical variable. 3 options: 1. the device has worked without problems 2. the device has worked, but with problems 3. the device could not carry out its function.

Time frame: at surgery