Radial Reload Laparoscopic LAR Case Series

Phase 4TerminatedNCT01706822

Medtronic - MITG8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

Covidien Radial Reload Stapler with Tri-Staple TechnologyDEVICE

Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Operative

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.

Time frame: Operative

Secondary Outcomes

Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree

1\. Access measured by surgeon usability questionnaire.

Time frame: Operatively

Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree

2\. Visibility measured by surgeon usability questionnaire

Time frame: Operatively

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

Time frame: Operatively

Data from ClinicalTrials.gov

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