Radial Reload Laparoscopic LAR Case Series

Phase 4

Terminated

• Conditions: Colorectal Cancer
• Interventions: Device: Covidien Radial Reload Stapler with Tri-Staple Technology

• Registration Number: NCT01706822
• Lead Sponsor: Medtronic - MITG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2015-02-13
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Results First Posted: 2015-03-18
• Last Update Posted: 2015-03-18

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.
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

• 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 laparoscopic LAR or proctosigmoidectomy

Primary Outcome Measures

Name	Time	Method
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	Operative	The surgeon's ability to achieve a staple line at the desired level of the rectum.
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	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
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree	Operatively	1. Access measured by surgeon usability questionnaire.
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree	Operatively	3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree	Operatively	2. Visibility measured by surgeon usability questionnaire

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States