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

Not Applicable

• Conditions: Oncological Rectal Surgery
• Interventions: Device: Rectoscope (P201630551)

• Registration Number: NCT04899726
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-14
• Status Verified: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Rectoscope (P201630551)	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of functionality	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.	at immediate postoperative period	Safety. Clavien-Dindo classification will be used.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain