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

Instituto de Investigación Hospital Universitario La Paz

Status: Unknown

Conditions: Oncological Rectal Surgery

Treatments: Device: Rectoscope (P201630551)

Study type: Interventional

Funder types: Other

Identifiers

NCT04899726

P201630551

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intervention

Experimental group

Description:

Oncology patients candidate for rectal surgery (tumors located up to 15 cm from the anal margin) and meet inclusion criteria. Rectoscope (P201630551) allows the identification of the distal section margin.

Treatment:

Device: Rectoscope (P201630551)