Radial Reload Open LAR Case Series

Medtronic - MITG8 enrolled

Overview

The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Anterior Resection Proctosigmoid Resection Rectal Cancer

Interventions

Covidien Radial Reload Stapler with Tri-Staple TechnologyDEVICE

Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject is able to understand and sign Informed Consent Form. 2. The subject is between 18-85 years of age. 3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer. 4. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision. Exclusion Criteria: 1. Any female patient, who is pregnant, suspected pregnant, or nursing. 2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule. 3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Locations (3)

University of South Florida

Tampa, Florida, United States

Duke University

Durham, North Carolina, United States

Providence Medical Center

Spokane, Washington, United States

Outcomes

Primary Outcomes

Staple Line

The surgeons ability to achieve a staple line at the desired level of the rectum.

Time frame: Operative

Distal Margins

The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.

Time frame: Operative

Secondary Outcomes

Usability: Visibility

Visibility measured by surgeon usability questionnaire.

Time frame: Operatively

Usability: Access

Access measured by surgeon usability questionnaire

Time frame: Operatively

Usability: Manueverability

Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate

Time frame: Operatively

Data from ClinicalTrials.gov

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