Left-sided Colon Resection
Conditions
Brief summary
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
Detailed description
Surgical staplers have been utilized in colorectal procedures since the early 20th century, with intraluminal staplers used to create the anastomosis since 1979. Successful utilization of these devices, whether in open or laparoscopic procedures, requires extensive training and experience. Even with experience, device issues such as stapler misfire, incomplete firing, low surgeon satisfaction, etc., may occur. In a retrospective study of 349 colorectal resections, 67 (19%) procedures had some type of technical error. The most frequently reported issues from the analysis were positive leak tests, difficulty placing or removing the stapler, and inadequate donuts. Surgeons may also experience psychological or physical stress during procedures due to complications, workload, or other factors. Patients scheduled to undergo a left-sided colon resection, and who meet study entry criteria, may be enrolled. Investigators will perform each procedure using the powered circular stapler according to the instructions for use (IFU). There will be no blinding or planned-interim analysis. Procedures may be performed open or via minimally invasive surgery (MIS) according to institutional standard-of-care (SOC). Use of a hand port and robotic assistance are permissible providing the powered circular stapler is used to create the anastomosis. Conversion from laparoscopic to open surgery is permissible under the protocol at the surgeon's discretion for the patient's safety. The final scheduled study visit will occur 28 days post-procedure (routinely scheduled follow-up with surgeon). Follow-up by phone is permissible when an on-site visit is not planned or is more than six weeks post-operative.
Interventions
DEVICELeft-sided colon resection
Left-sided colon resection with powered stapler
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler; 2. Willing to give consent and comply with all study-related evaluations; and 3. At least 18 years of age.
Exclusion criteria
1. Enrollment in a concurrent clinical study; 2. Pregnancy; 3. Physical or psychological condition which would impair study participation; 4. Emergency surgery; 5. ASA Class ≥ IV; 6. The subject is judged unsuitable for study participation by the Investigator; or 7. Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections; 9\. Anastomosis not distal from splenic flexure of the colon 10. Anastomosis of the colon not attempted 11. Subjects with any intraoperative findings identified by the surgeon that would preclude attempting an anastomosis with a circular stapler.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Stapler Performance Issues | Intraoperative | A stapler performance issue is defined as a failure of the ECHELON CIRCULAR Powered Stapler to perform per its instructions for use. This includes but is not limited to difficulty placing or removing the stapler, stapler misfire/failure of the device to fully fire, staple line defects, incomplete or thin donuts, tissue damage, positive intraoperative leak test, detached components, unformed staples, or any other device failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SURG-TLX Questionnaire | Collected postoperative for intraoperative stress | The Surgery Task Load index (SURG-TLX) questionnaire was completed by the participating surgeon following each procedure. The questionnaire was used to provide an assessment of surgical stress (surgeon) associated with the procedure (defined as the creation of the anastomosis). There are six specific components (mental, physical, temporal, task, situational, and distractions) that are used for evaluating the surgeon experience after each surgery is performed. Each component is scored on a 0 to 100 scale with lower scores representing a low response on that component and higher scores indicating a high response on that component. An overall score is also calculated as the average of the six components for each procedure. |
Countries
Belgium, Germany, Spain, United Kingdom, United States
Participant flow
Recruitment details
All subjects who underwent surgery and had an anastomosis attempted with the ECHELON CIRCULAR Powered stapler were included in performance and safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| ECHELON CIRCULAR Powered Stapler Use of the ECHELON CIRCULAR Powered Stapler | 168 |
| Total | 168 |
Baseline characteristics
| Characteristic | ECHELON CIRCULAR Powered Stapler |
|---|---|
| Age, Continuous | 59.9 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 11 Participants |
| Race (NIH/OMB) White | 149 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 168 |
| other Total, other adverse events | 32 / 168 |
| serious Total, serious adverse events | 13 / 168 |
Outcome results
Primary
Percentage of Participants With Stapler Performance Issues
A stapler performance issue is defined as a failure of the ECHELON CIRCULAR Powered Stapler to perform per its instructions for use. This includes but is not limited to difficulty placing or removing the stapler, stapler misfire/failure of the device to fully fire, staple line defects, incomplete or thin donuts, tissue damage, positive intraoperative leak test, detached components, unformed staples, or any other device failure.
Time frame: Intraoperative
Population: Number of subjects with at least performance issue.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ECHELON CIRCULAR Powered Stapler | Percentage of Participants With Stapler Performance Issues | 11.9 Percentage of subjects |
Secondary
SURG-TLX Questionnaire
The Surgery Task Load index (SURG-TLX) questionnaire was completed by the participating surgeon following each procedure. The questionnaire was used to provide an assessment of surgical stress (surgeon) associated with the procedure (defined as the creation of the anastomosis). There are six specific components (mental, physical, temporal, task, situational, and distractions) that are used for evaluating the surgeon experience after each surgery is performed. Each component is scored on a 0 to 100 scale with lower scores representing a low response on that component and higher scores indicating a high response on that component. An overall score is also calculated as the average of the six components for each procedure.
Time frame: Collected postoperative for intraoperative stress
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Situational Stress (How anxious did you feel while performing the procedure?) | 38.6 Scores on a Scale | Standard Deviation 27.3 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Distractions (How distracting was the operating environment?) | 26.5 Scores on a Scale | Standard Deviation 21 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Overall Score | 38.0 Scores on a Scale | Standard Deviation 21.6 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Mental Demands (How mentally fatiguing was the procedure?) | 44.9 Scores on a Scale | Standard Deviation 27.8 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Physical Demands (How physically fatiguing was the procedure?) | 37.9 Scores on a Scale | Standard Deviation 26.5 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Temporal Demands (How hurried or rushed was the pace of the procedure?) | 30.3 Scores on a Scale | Standard Deviation 22.6 |
| ECHELON CIRCULAR Powered Stapler | SURG-TLX Questionnaire | Task Complexity (How complex was the procedure?) | 50.3 Scores on a Scale | Standard Deviation 28.6 |