EPMCS-CA: A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Powered circular stapler used to complete anastomosis of colon |
Device: Left-sided colon resection
Left-sided colon resection with powered stapler
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler;
-
Willing to give consent and comply with all study-related evaluations; and
-
At least 18 years of age.
Exclusion Criteria:
-
Enrollment in a concurrent clinical study;
-
Pregnancy;
-
Physical or psychological condition which would impair study participation;
-
Emergency surgery;
-
ASA Class ≥ IV;
-
The subject is judged unsuitable for study participation by the Investigator; or
-
Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections;
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 35294-0016 |
| 2 | Colon & Rectal Clinic of Orlando | Orlando | Florida | United States | 32806 |
| 3 | AdventHealth Tampa | Tampa | Florida | United States | 33613 |
| 4 | Spectrum Health System | Grand Rapids | Michigan | United States | 49503 |
| 5 | Mt. Sinai Hospital / Mt. Sinai School of Medicine | New York | New York | United States | 10029 |
| 6 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 7 | Ziekenhuis Oost-Limburg | Genk | Belgium | 3600 | |
| 8 | Schon Klinik Neustadt | Neustadt | Germany | 23730 | |
| 9 | Hospital Universitario Virgen Rocio | Sevilla | Spain | 41013 | |
| 10 | University Hospitals Birmingham NHS | Birmingham | United Kingdom | B15 2TH | |
| 11 | St Jame's University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 12 | St. Mary's Hospital | London | United Kingdom |
Sponsors and Collaborators
- Ethicon Endo-Surgery
Investigators
- Principal Investigator: Daniel Herzig, MD, Oregon Health and Science University
Study Documents (Full-Text)
More Information
Publications
None provided.- ESC-16-002
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ECHELON CIRCULAR Powered Stapler |
|---|---|
| Arm/Group Description | Use of the ECHELON CIRCULAR Powered Stapler |
| Period Title: Overall Study | |
| STARTED | 168 |
| COMPLETED | 168 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | ECHELON CIRCULAR Powered Stapler |
|---|---|
| Arm/Group Description | Use of the ECHELON CIRCULAR Powered Stapler |
| Overall Participants | 168 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
59.9
(13.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
79
47%
|
| Male |
89
53%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
13
7.7%
|
| Not Hispanic or Latino |
152
90.5%
|
| Unknown or Not Reported |
3
1.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
1.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
3%
|
| White |
149
88.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
11
6.5%
|
Outcome Measures
| Title | Percentage of Participants With Stapler Performance Issues |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects with at least performance issue. |
| Arm/Group Title | ECHELON CIRCULAR Powered Stapler |
|---|---|
| Arm/Group Description | Use of the ECHELON CIRCULAR Powered Stapler |
| Measure Participants | 168 |
| Number (95% Confidence Interval) [Percentage of subjects] |
11.9
|
| Title | SURG-TLX Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ECHELON CIRCULAR Powered Stapler |
|---|---|
| Arm/Group Description | Use of the ECHELON CIRCULAR Powered Stapler |
| Measure Participants | 168 |
| Overall Score |
38.0
(21.60)
|
| Mental Demands (How mentally fatiguing was the procedure?) |
44.9
(27.8)
|
| Physical Demands (How physically fatiguing was the procedure?) |
37.9
(26.5)
|
| Temporal Demands (How hurried or rushed was the pace of the procedure?) |
30.3
(22.6)
|
| Task Complexity (How complex was the procedure?) |
50.3
(28.6)
|
| Situational Stress (How anxious did you feel while performing the procedure?) |
38.6
(27.3)
|
| Distractions (How distracting was the operating environment?) |
26.5
(21.0)
|
Adverse Events
| Time Frame | 4 Weeks Post Procedure | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | ECHELON CIRCULAR Powered Stapler | |
| Arm/Group Description | Use of the ECHELON CIRCULAR Powered Stapler | |
All Cause Mortality |
||
| ECHELON CIRCULAR Powered Stapler | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/168 (0%) | |
Serious Adverse Events |
||
| ECHELON CIRCULAR Powered Stapler | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/168 (7.7%) | |
| Gastrointestinal disorders | ||
| Abdominal Pain | 1/168 (0.6%) | |
| Ileus | 1/168 (0.6%) | |
| Large Intestinal Obstruction | 1/168 (0.6%) | |
| Infections and infestations | ||
| Pelvic Abscess | 2/168 (1.2%) | |
| Urinary Tract Infection | 1/168 (0.6%) | |
| Wound Infection | 1/168 (0.6%) | |
| Injury, poisoning and procedural complications | ||
| Gastrointestinal Stoma Complication | 3/168 (1.8%) | |
| Anastomotic Leak | 2/168 (1.2%) | |
| Anastomotic Stenosis | 1/168 (0.6%) | |
| Incision Site Pain | 1/168 (0.6%) | |
| Post Procedural Hemorrhage | 1/168 (0.6%) | |
| Post-operative Ileus | 1/168 (0.6%) | |
| Stoma Complication | 1/168 (0.6%) | |
| Stoma Site Erythema | 1/168 (0.6%) | |
| Investigations | ||
| C-reactive Protein Increased | 1/168 (0.6%) | |
Other (Not Including Serious) Adverse Events |
||
| ECHELON CIRCULAR Powered Stapler | ||
| Affected / at Risk (%) | # Events | |
| Total | 32/168 (19%) | |
| Gastrointestinal disorders | ||
| Abdominal Pain | 12/168 (7.1%) | |
| Nausea | 8/168 (4.8%) | |
| Vomiting | 8/168 (4.8%) | |
| Constipation | 3/168 (1.8%) | |
| Dyspepsia | 3/168 (1.8%) | |
| General disorders | ||
| Pyrexia | 4/168 (2.4%) | |
| Injury, poisoning and procedural complications | ||
| Procedural Pain | 5/168 (3%) | |
| Investigations | ||
| Oxygen Saturation Decreased | 3/168 (1.8%) | |
| Renal and urinary disorders | ||
| Acute Kidney Injury | 4/168 (2.4%) | |
| Urinary Retention | 3/168 (1.8%) | |
| Vascular disorders | ||
| Hypotension | 4/168 (2.4%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jason Waggoner, PhD |
|---|---|
| Organization | Ethicon Endo-Surgery |
| Phone | +1 513.337.8310 |
| jwaggon1@its.jnj.com |
- ESC-16-002