A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses

Left-sided Colon Resection Clinical Trial

— EPMCS-CA  

Official title:

A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326895
• Other study ID #: ESC-16-002
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2021
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 15, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Left-sided Colon Resection

Intervention

Device:
• Left-sided colon resection
Left-sided colon resection with powered stapler

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Germany	Schon Klinik Neustadt	Neustadt
Spain	Hospital Universitario Virgen Rocio	Sevilla
United Kingdom	University Hospitals Birmingham NHS	Birmingham
United Kingdom	St Jame's University Hospital	Leeds
United Kingdom	St. Mary's Hospital	London
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Mt. Sinai Hospital / Mt. Sinai School of Medicine	New York	New York
United States	Colon & Rectal Clinic of Orlando	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	AdventHealth Tampa	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Intraoperative
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.	Collected postoperative for intraoperative stress