Radial Reload Open LAR Case Series
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.
Low Anterior Resection
Device: Covidien Radial Reload Stapler
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series|
- Staple Line [ Time Frame: Operative ] [ Designated as safety issue: No ]The surgeon's ability to achieve a staple line at the desired level of the rectum.
- Distal Margins [ Time Frame: Operative ] [ Designated as safety issue: No ]The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.
- Usability [ Time Frame: Operatively ] [ Designated as safety issue: No ]
- Access measured by surgeon usability questionnaire.
- Visibility measured by surgeon usability questionnaire.
- Maneuverability measured by surgeon usability questionnaire.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: Covidien Radial Reload Stapler||Device: Covidien Radial Reload Stapler|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717014
|Contact: Jessica Chowaniecemail@example.com|
|Contact: Jessica Carlsonfirstname.lastname@example.org|
|United States, Florida|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Shaun Crittenden 813-844-4069|
|Principal Investigator: Sowsan H. Rasheid, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Principal Investigator: Christopher Mantyh, MD|
|United States, Washington|
|Providence Medical Center||Recruiting|
|Spokane, Washington, United States, 99204|
|Contact: Joan Milton 509-474-4323|
|Principal Investigator: M. Shane McNevin, MD|