Radial Reload Laparoscopic LAR Case Series

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01706822
• Other study ID #: COVLARL0287
• Status: Terminated
• Phase: Phase 4
• First received: October 11, 2012
• Last updated: March 17, 2015
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

4. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Device:
• Covidien Radial Reload Stapler with Tri-Staple Technology
Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Medtronic - MITG	Duke University, University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No