Clinical trial NCT03326895: A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Official title: A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left-sided Colon Resection
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Stapler Performance Issues
timeFrame: Intraoperative
Secondary outcomes:
measure: SURG-TLX Questionnaire
timeFrame: Collected postoperative for intraoperative stress
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Orlando
country: United States
facility: Colon & Rectal Clinic of Orlando
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: New York
country: United States
facility: Mt. Sinai Hospital / Mt. Sinai School of Medicine
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Neustadt
country: Germany
facility: Schon Klinik Neustadt
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Rocio
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS
city: Leeds
country: United Kingdom
facility: St Jame's University Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Oregon Health and Science University
name: Daniel Herzig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.