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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Powered circular stapler used to complete anastomosis of colon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left-sided colon resection | Device | Left-sided colon resection with powered stapler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Herzig, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294-0016 | United States | ||
| Colon & Rectal Clinic of Orlando |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33176211 | Result | Herzig DO, Ogilvie JW, Chudzinski A, Ferrara A, Ashraf SQ, Jimenez-Rodriguez RM, Van der Speeten K, Kinross J, Schimmelpenning H, Sagar PM, Cannon JA, Schwiers ML, Singleton DW, Waggoner JR, Fryrear R 2nd, Sylla P. Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study. Int J Surg. 2020 Dec;84:140-146. doi: 10.1016/j.ijsu.2020.11.001. Epub 2020 Nov 8. |
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Primary endpoint
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All subjects who underwent surgery and had an anastomosis attempted with the ECHELON CIRCULAR Powered stapler were included in performance and safety analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | ECHELON CIRCULAR Powered Stapler | Use of the ECHELON CIRCULAR Powered Stapler |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2018 | Dec 2, 2020 |
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| Collected postoperative for intraoperative stress |
| Orlando |
| Florida |
| 32806 |
| United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Spectrum Health System | Grand Rapids | Michigan | 49503 | United States |
| Mt. Sinai Hospital / Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| Schon Klinik Neustadt | Neustadt | 23730 | Germany |
| Hospital Universitario Virgen Rocio | Seville | 41013 | Spain |
| University Hospitals Birmingham NHS | Birmingham | B15 2TH | United Kingdom |
| St Jame's University Hospital | Leeds | LS9 7TF | United Kingdom |
| St. Mary's Hospital | London | United Kingdom |
| COMPLETED | 168 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ECHELON CIRCULAR Powered Stapler | Use of the ECHELON CIRCULAR Powered Stapler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of subjects with at least performance issue. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Intraoperative |
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| 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Collected postoperative for intraoperative stress |
|
|
4 Weeks Post Procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECHELON CIRCULAR Powered Stapler | Use of the ECHELON CIRCULAR Powered Stapler | 0 | 168 | 13 | 168 | 32 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anastomotic Leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Anastomotic Stenosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision Site Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post Procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post-operative Ileus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Stoma Site Erythema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pelvic Abscess | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Wound Infection | Infections and infestations | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Large Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| C-reactive Protein Increased | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Oxygen Saturation Decreased | Investigations | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Waggoner, PhD | Ethicon Endo-Surgery | +1 513.337.8310 | jwaggon1@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2020 | Dec 2, 2020 | SAP_001.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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