Trial Outcomes & Findings for A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses (NCT NCT03326895)

Last Updated: 2021-01-11

Results Overview

A stapler performance issue is defined as a failure of the ECHELON CIRCULAR Powered Stapler to perform per its instructions for use. This includes but is not limited to difficulty placing or removing the stapler, stapler misfire/failure of the device to fully fire, staple line defects, incomplete or thin donuts, tissue damage, positive intraoperative leak test, detached components, unformed staples, or any other device failure.

Recruitment status

COMPLETED

Study phase

Target enrollment

168 participants

Primary outcome timeframe

Intraoperative

Results posted on

2021-01-11

Participant Flow

All subjects who underwent surgery and had an anastomosis attempted with the ECHELON CIRCULAR Powered stapler were included in performance and safety analyses.

Participant milestones

Participant milestones
Measure	ECHELON CIRCULAR Powered Stapler Use of the ECHELON CIRCULAR Powered Stapler
Overall Study STARTED	168
Overall Study COMPLETED	168
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ECHELON CIRCULAR Powered Stapler n=168 Participants Use of the ECHELON CIRCULAR Powered Stapler
Age, Continuous	59.9 Years STANDARD_DEVIATION 13.0 • n=93 Participants
Sex: Female, Male Female	79 Participants n=93 Participants
Sex: Female, Male Male	89 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	152 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	149 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: Number of subjects with at least performance issue.

Outcome measures

Outcome measures
Measure	ECHELON CIRCULAR Powered Stapler n=168 Participants Use of the ECHELON CIRCULAR Powered Stapler
Percentage of Participants With Stapler Performance Issues	11.9 Percentage of subjects Interval 7.4 to 17.8

SECONDARY outcome

Timeframe: Collected postoperative for intraoperative stress

The Surgery Task Load index (SURG-TLX) questionnaire was completed by the participating surgeon following each procedure. The questionnaire was used to provide an assessment of surgical stress (surgeon) associated with the procedure (defined as the creation of the anastomosis). There are six specific components (mental, physical, temporal, task, situational, and distractions) that are used for evaluating the surgeon experience after each surgery is performed. Each component is scored on a 0 to 100 scale with lower scores representing a "low" response on that component and higher scores indicating a "high" response on that component. An overall score is also calculated as the average of the six components for each procedure.

Outcome measures

Outcome measures
Measure	ECHELON CIRCULAR Powered Stapler n=168 Participants Use of the ECHELON CIRCULAR Powered Stapler
SURG-TLX Questionnaire Overall Score	38.0 Scores on a Scale Standard Deviation 21.60
SURG-TLX Questionnaire Mental Demands (How mentally fatiguing was the procedure?)	44.9 Scores on a Scale Standard Deviation 27.8
SURG-TLX Questionnaire Physical Demands (How physically fatiguing was the procedure?)	37.9 Scores on a Scale Standard Deviation 26.5
SURG-TLX Questionnaire Temporal Demands (How hurried or rushed was the pace of the procedure?)	30.3 Scores on a Scale Standard Deviation 22.6
SURG-TLX Questionnaire Task Complexity (How complex was the procedure?)	50.3 Scores on a Scale Standard Deviation 28.6
SURG-TLX Questionnaire Situational Stress (How anxious did you feel while performing the procedure?)	38.6 Scores on a Scale Standard Deviation 27.3
SURG-TLX Questionnaire Distractions (How distracting was the operating environment?)	26.5 Scores on a Scale Standard Deviation 21.0

Adverse Events

ECHELON CIRCULAR Powered Stapler

Serious events: 13 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ECHELON CIRCULAR Powered Stapler n=168 participants at risk Use of the ECHELON CIRCULAR Powered Stapler
Injury, poisoning and procedural complications Gastrointestinal Stoma Complication	1.8% 3/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Anastomotic Leak	1.2% 2/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Anastomotic Stenosis	0.60% 1/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Incision Site Pain	0.60% 1/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Post Procedural Hemorrhage	0.60% 1/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Post-operative Ileus	0.60% 1/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Stoma Complication	0.60% 1/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Stoma Site Erythema	0.60% 1/168 • 4 Weeks Post Procedure
Infections and infestations Pelvic Abscess	1.2% 2/168 • 4 Weeks Post Procedure
Infections and infestations Urinary Tract Infection	0.60% 1/168 • 4 Weeks Post Procedure
Infections and infestations Wound Infection	0.60% 1/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Abdominal Pain	0.60% 1/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Ileus	0.60% 1/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Large Intestinal Obstruction	0.60% 1/168 • 4 Weeks Post Procedure
Investigations C-reactive Protein Increased	0.60% 1/168 • 4 Weeks Post Procedure

Other adverse events

Other adverse events
Measure	ECHELON CIRCULAR Powered Stapler n=168 participants at risk Use of the ECHELON CIRCULAR Powered Stapler
Gastrointestinal disorders Abdominal Pain	7.1% 12/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Nausea	4.8% 8/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Vomiting	4.8% 8/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Constipation	1.8% 3/168 • 4 Weeks Post Procedure
Gastrointestinal disorders Dyspepsia	1.8% 3/168 • 4 Weeks Post Procedure
Injury, poisoning and procedural complications Procedural Pain	3.0% 5/168 • 4 Weeks Post Procedure
Renal and urinary disorders Acute Kidney Injury	2.4% 4/168 • 4 Weeks Post Procedure
Renal and urinary disorders Urinary Retention	1.8% 3/168 • 4 Weeks Post Procedure
Investigations Oxygen Saturation Decreased	1.8% 3/168 • 4 Weeks Post Procedure
General disorders Pyrexia	2.4% 4/168 • 4 Weeks Post Procedure
Vascular disorders Hypotension	2.4% 4/168 • 4 Weeks Post Procedure

Additional Information

Jason Waggoner, PhD

Ethicon Endo-Surgery

Phone: +1 513.337.8310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60