Radial Reload Open LAR Case Series

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Anterior Resection, Proctosigmoid Resection, Rectal 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 for the treatment of rectal cancer. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision. 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 open low anterior resection or anterior proctosigmoidectomy | Device: Covidien Radial Reload Stapler with Tri-Staple Technology<br>* Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staple Line | The surgeons ability to achieve a staple line at the desired level of the rectum. | Operative | 
| Distal Margins | 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 |
| --- | --- | --- |
| Usability: Visibility | Visibility measured by surgeon usability questionnaire. | Operatively | 
| Usability: Access | Access measured by surgeon usability questionnaire | Operatively | 
| Usability: Manueverability | Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate | Operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, stapler