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Radial Reload Laparoscopic LAR Case Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706822
Recruitment Status : Terminated (Slow recruitment)
First Posted : October 15, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Collaborators:
University Hospitals Cleveland Medical Center
Duke University
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: Covidien Radial Reload Stapler with Tri-Staple Technology Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Covidien Radial Reload Stapler with Tri-Staple Technology
Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic LAR or proctosigmoidectomy
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Operative ]
    The surgeon's ability to achieve a staple line at the desired level of the rectum.

  2. 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 [ Time Frame: Operative ]
    The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.


Secondary Outcome Measures :
  1. Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ]
    1. Access measured by surgeon usability questionnaire.

  2. Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ]
    2. Visibility measured by surgeon usability questionnaire

  3. Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree [ Time Frame: Operatively ]
    3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706822


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Medtronic - MITG
University Hospitals Cleveland Medical Center
Duke University
Investigators
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Principal Investigator: Conor Delaney, MD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01706822    
Other Study ID Numbers: COVLARL0287
First Posted: October 15, 2012    Key Record Dates
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases