Radial Reload Laparoscopic LAR Case Series

Study Overview
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Brief Summary
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To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.

Official Title
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Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Laparoscopic Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Covidien Radial Reload Stapler with Tri-Staple Technology


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Covidien Radial Reload Stapler with Tri-Staple Technology<br>Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic LAR or proctosigmoidectomy | Device: Covidien Radial Reload Stapler with Tri-Staple Technology<br>* Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | The surgeon's ability to achieve a staple line at the desired level of the rectum. | Operative | 
| The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum. | Operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 1. Access measured by surgeon usability questionnaire. | Operatively | 
| Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 2. Visibility measured by surgeon usability questionnaire | Operatively | 
| Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate | Operatively |