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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectoscope (P201630551) | Device | Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events related to use of the device. | Safety. Clavien-Dindo classification will be used. | at immediate postoperative period |
| Evaluation of functionality | Categorical variable. 3 options:
| at surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D020700 | Proctoscopes |
| ID | Term |
|---|---|
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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Pilot Study
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| D013523 |
| Surgical Equipment |