Low Anterior Resection, Proctosigmoid Resection, Rectal Cancer
Conditions
Keywords
rectal cancer, stapler
Brief summary
The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.
Interventions
Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler
Sponsors
Duke University
Providence Medical Research Center
University of South Florida
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 for the treatment of rectal cancer. 4. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.
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 |
|---|---|---|
| Staple Line | Operative | The surgeons ability to achieve a staple line at the desired level of the rectum. |
| Distal Margins | 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 |
|---|---|---|
| Usability: Visibility | Operatively | Visibility measured by surgeon usability questionnaire. |
| Usability: Access | Operatively | Access measured by surgeon usability questionnaire |
| Usability: Manueverability | Operatively | Manueverability 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 open low anterior resection or anterior proctosigmoidectomy | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Covidien Radial Reload Stapler With Tri-Staple Technology |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 14.8 |
| Body Mass Index (BMI) | 29.0 kg/m2 STANDARD_DEVIATION 6.1 |
| 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 | 175.1 centimeters STANDARD_DEVIATION 4.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 88.7 kilograms STANDARD_DEVIATION 18 |
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
Distal Margins
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 | Distal Margins | 8 participants |
Primary
Staple Line
The surgeons 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 | Staple Line | 7 participants |
Secondary
Usability: Access
Access measured by surgeon usability questionnaire
Time frame: Operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | Radial Reload (RR) easy to place in pelvis | 100 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | RR was able to get low in pelvis | 100 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | RR was easy to place in the colon & rectum | 100 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | Was rectum contained in the device after clamping | 12.5 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | RR retained an adequate tissue during clamping | 100 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Access | Was the rectum transected in one firing | 12.5 % of cases surgeon agree/strongly agree |
Secondary
Usability: Manueverability
Manueverability 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 | Usability: Manueverability | 87.5 % of cases surgeon agree/strongly agree |
Secondary
Usability: Visibility
Visibility measured by surgeon usability questionnaire.
Time frame: Operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Visibility | Visibility adequate when RR was used operatively | 100 % of cases surgeon agree/strongly agree |
| Covidien Radial Reload Stapler With Tri-Staple Technology | Usability: Visibility | Did instrument impede visibility | 0 % of cases surgeon agree/strongly agree |