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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2022-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Oncological Rectal Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot Study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rectoscope (P201630551)

Intervention Type DEVICE

Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.

Interventions

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Rectoscope (P201630551)

Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No