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

NCT ID: NCT03326895

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2020-01-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Powered circular stapler used to complete anastomosis of colon

Group Type: EXPERIMENTAL

Left-sided colon resection

Intervention Type: DEVICE

Left-sided colon resection with powered stapler

Interventions

Left-sided colon resection

Left-sided colon resection with powered stapler

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Herzig, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Colon & Rectal Clinic of Orlando

Orlando, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

Spectrum Health System

Grand Rapids, Michigan, United States

Mt. Sinai Hospital / Mt. Sinai School of Medicine

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Ziekenhuis Oost-Limburg

Genk, , Belgium

Schon Klinik Neustadt

Neustadt, , Germany

Hospital Universitario Virgen Rocio

Seville, , Spain

University Hospitals Birmingham NHS

Birmingham, , United Kingdom

St Jame's University Hospital

Leeds, , United Kingdom

St. Mary's Hospital

London, , United Kingdom

Countries

United States; Belgium; Germany; Spain; United Kingdom

References

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.

Reference Type: RESULT

PMID: 33176211 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ESC-16-002

Identifier Type: -

Identifier Source: org_study_id