NCT03326895

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Left-sided colon resection	Left-sided colon resection with powered stapler

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-12-06
• Completion: 2020-01-15
• First posted: 2017-10-31
• Last updated: 2021-01-11
• Results posted: 2021-01-11

Locations

12 sites across 5 countries: United States, Belgium, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated device study