Trial Outcomes & Findings for Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis (NCT NCT05320029)
NCT ID: NCT05320029
Last Updated: 2023-12-14
Results Overview
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
During surgery
Results posted on
2023-12-14
Participant Flow
Participant milestones
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
COMPLETED
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=80 Participants
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
n=80 Participants
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.16 years
STANDARD_DEVIATION 10.85 • n=80 Participants
|
60.40 years
STANDARD_DEVIATION 11.06 • n=80 Participants
|
59.78 years
STANDARD_DEVIATION 10.94 • n=160 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=80 Participants
|
27 Participants
n=80 Participants
|
50 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=80 Participants
|
53 Participants
n=80 Participants
|
110 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
80 participants
n=80 Participants
|
80 participants
n=80 Participants
|
160 participants
n=160 Participants
|
|
BMI
|
23.00 kg/m2
STANDARD_DEVIATION 2.45 • n=80 Participants
|
22.83 kg/m2
STANDARD_DEVIATION 2.90 • n=80 Participants
|
22.91 kg/m2
STANDARD_DEVIATION 2.68 • n=160 Participants
|
PRIMARY outcome
Timeframe: During surgeryThe transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
Outcome measures
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=80 Participants
Gastrointestinal tumor surgery: Only the brand of powered cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
n=80 Participants
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
|---|---|---|
|
Number of Participants With Anastomosis Success
|
80 Participants
|
80 Participants
|
Adverse Events
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Serious events: 11 serious events
Other events: 65 other events
Deaths: 0 deaths
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
Serious events: 9 serious events
Other events: 68 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=80 participants at risk
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
n=80 participants at risk
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
|---|---|---|
|
Infections and infestations
Intra-abdominal infection
|
5.0%
4/80 • Number of events 4 • 30 days
|
5.0%
4/80 • Number of events 4 • 30 days
|
|
Gastrointestinal disorders
gastric retention
|
1.2%
1/80 • Number of events 1 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
General disorders
Death
|
0.00%
0/80 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Eating obstruction
|
0.00%
0/80 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Esophagojejunostomotic fistula
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Infections and infestations
Infection of incisional wound
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Gastrointestinal disorders
The anastomosis is narrow
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Infections and infestations
Pelvic infection
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/80 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Hemorrhage of digestive tract
|
1.2%
1/80 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Hepatobiliary disorders
Cholecystolithiasis
|
0.00%
0/80 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=80 participants at risk
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
n=80 participants at risk
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
|---|---|---|
|
Metabolism and nutrition disorders
hypoproteinemia
|
28.7%
23/80 • Number of events 24 • 30 days
|
28.7%
23/80 • Number of events 23 • 30 days
|
|
General disorders
fever
|
22.5%
18/80 • Number of events 18 • 30 days
|
18.8%
15/80 • Number of events 15 • 30 days
|
|
Injury, poisoning and procedural complications
incision pain
|
18.8%
15/80 • Number of events 15 • 30 days
|
21.2%
17/80 • Number of events 18 • 30 days
|
|
General disorders
other
|
11.2%
9/80 • 30 days
|
16.2%
13/80 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place