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

Ethicon

Status: Completed

Conditions: Left-sided Colon Resection

Treatments: Device: Left-sided colon resection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03326895

ESC-16-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

8. 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Group 1

Experimental group

Description:

Powered circular stapler used to complete anastomosis of colon

Treatment:

Device: Left-sided colon resection