Oncological Rectal Surgery
Conditions
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.
Interventions
DEVICERectoscope (P201630551)
Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events related to use of the device. | at immediate postoperative period | Safety. Clavien-Dindo classification will be used. |
| 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. |
Countries
Spain
Outcome results
None listed