An interventional study of Rectoscope (P201630551) in Oncological Rectal Surgery, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Other
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.
Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Rectoscope (P201630551)
Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.
Number of adverse events related to use of the device.
Safety. Clavien-Dindo classification will be used.
Time frame: at immediate postoperative period
Evaluation of functionality
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.
Time frame: at surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Hospital Universitario La Paz