Colorectal Cancer
Conditions
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.
Interventions
Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler
Sponsors
University Hospitals Cleveland Medical Center
Duke University
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Covidien Radial Reload Stapler With Tri-Staple Technology |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10.8 |
| Body Mass Index (BMI) | 27.0 kg/m2 STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 165.0 centimeters STANDARD_DEVIATION 11.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
| Weight | 73.9 kilograms STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 4 / 8 |
Outcome results
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.
Time frame: Operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | 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 | 7 participants |
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.
Time frame: Operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | 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 | 6 participants |
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.
Time frame: Operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | Radial Reload (RR) easy to place in pelvis | 62.5 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | RR was easy to get low in the pelvis | 87.5 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | RR was easy to place in the colon and the rectum | 50 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | Was the rectum contained in device after clamping | 50 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | RR retained an adequate amount of tissue | 75 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | Was the rectum transected with one firing | 12.5 % of cases surgeon agree/strongly agree |
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
Time frame: Operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 62.5 % of cases surgeon agree/strongly agree |
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
Time frame: Operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | Visibility was adequate when RR was used | 87.5 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | Did the instrument impede the visibility | 0 % of cases surgeon agree/strongly agree |