Evaluating Safety and Feasibility of the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter 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:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating Safety and Feasibility of the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series|
- Safety [ Time Frame: 30 Day follow-up ] [ Designated as safety issue: Yes ]Safety: evaluated through reported adverse events which include complications.
- Feasibility [ Time Frame: Operatively ] [ Designated as safety issue: No ]Assessed by a) the surgeon's ability to achieve a staple line at the desired level of the rectum, and b) by adequate distal margins (defined as >2 cm or >1 cm with clear histologic evaluation in the low rectum.
- Device Usability and Access as measured by Surgeon opinion [ 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:||November 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Covidien Radial Reload Stapler||Device: Covidien Radial Reload Stapler|
|Contact: Jessica Chowaniecemail@example.com|
|Contact: Jessica Carlsonfirstname.lastname@example.org|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|