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