Radial Reload Open LAR Case Series

Not Applicable

Terminated

• Conditions: Rectal Cancer; Low Anterior Resection; Proctosigmoid Resection
• Interventions: Device: Covidien Radial Reload Stapler with Tri-Staple Technology

• Registration Number: NCT01717014
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-02
• Results First Submitted: 2015-02-13
• Results First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Results First Posted: 2015-03-02
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Covidien Radial Reload Stapler with Tri-Staple Technology	Covidien Radial Reload Stapler with Tri-Staple Technology	Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy

Primary Outcome Measures

Name	Time	Method
Staple Line	Operative	The surgeons ability to achieve a staple line at the desired level of the rectum.
Distal Margins	Operative	The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.

Secondary Outcome Measures

Name	Time	Method
Usability: Access	Operatively	Access measured by surgeon usability questionnaire
Usability: Visibility	Operatively	Visibility measured by surgeon usability questionnaire.
Usability: Manueverability	Operatively	Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate

Trial Locations

Locations (3)

Providence Medical Center; 🇺🇸 Spokane, Washington, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Duke University; 🇺🇸 Durham, North Carolina, United States