Left-sided Colon ResectionEPMCS-CANCT03326895
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
A study testing Left-sided colon resection in people with Left-sided Colon Resection, run by Ethicon Endo-Surgery at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left-sided Colon Resection
- What is being tested?
- Left-sided colon resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 20 Nov 2017to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United States6 sites
University of Alabama Birmingham
Birmingham, Alabama, 35294-0016
Spectrum Health System
Grand Rapids, Michigan, 49503
Mt. Sinai Hospital / Mt. Sinai School of Medicine
New York, New York, 10029
Colon & Rectal Clinic of Orlando
Orlando, Florida, 32806
Oregon Health & Science University
Portland, Oregon, 97239
AdventHealth Tampa
Tampa, Florida, 33613
United Kingdom3 sites
University Hospitals Birmingham NHS
Birmingham, B15 2TH
St Jame's University Hospital
Leeds, LS9 7TF
St. Mary's Hospital
London
About this study
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.
Read the 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.
- Conditions
- Left-sided Colon Resection
- Being tested
- Left-sided colon resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left-sided colon resectionDevice
Left-sided colon resection with powered stapler
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Powered circular stapler used to complete anastomosis of colon Receives: Device: Left-sided colon resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Secondary outcomes (1)
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.
Measured: Collected postoperative for intraoperative stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start20 Nov 2017
- Primary completion6 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left-sided Colon ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Herzig, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326895
- Sponsor's protocol ID
- ESC-16-002
- Acronym
- EPMCS-CA
- Status last verified
- Jan 2021
- First submitted
- 9 Oct 2017
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Primary endpoint
Publications
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.
PubMed 33176211
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
- ClinicalTrials.gov ID
- NCT03326895
- Acronym / sponsor ID
- EPMCS-CA / ESC-16-002
- Conditions
- Left-sided Colon Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Left-sided colon resectionPowered circular stapler used to complete anastomosis of colon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Enrollment in a concurrent clinical study;
- Pregnancy;
- Physical or psychological condition which would impair study participation;
- Emergency surgery;
- ASA Class ≥ IV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left-sided colon resectionLeft-sided colon resection with powered stapler | Device | Group 1 |
Primary outcome
Percentage of Participants With Stapler Performance Issues
Time frame: 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.
1 secondary outcome
SURG-TLX Questionnaire
Time frame: Collected postoperative for intraoperative stress
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33176211Herzig 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.
- Individual participant dataSharing planned: Yes. Primary endpoint
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Herzig, MD principal investigator
Oregon Health and Science University
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left-sided colon resection in people with Left-sided Colon Resection, run by Ethicon Endo-Surgery at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Belgium, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Stapler Performance Issues (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.