Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Evaluation of functionality
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention
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.
Intervention: Rectoscope (P201630551) (Device)
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.
Secondary Outcomes
No secondary outcomes reported