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Clinical Trials/NCT04899726
NCT04899726
Unknown
Not Applicable

Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery

Instituto de Investigación Hospital Universitario La Paz1 site in 1 country15 target enrollmentJuly 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oncological Rectal Surgery
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Enrollment
15
Locations
1
Primary Endpoint
Evaluation of functionality
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 14, 2020
End Date
September 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Evaluation of functionality

Time Frame: at surgery

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.

Number of adverse events related to use of the device.

Time Frame: at immediate postoperative period

Safety. Clavien-Dindo classification will be used.

Study Sites (1)

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