Trial Outcomes & Findings for Tri Staple Technology Stapler Used in Gastric Bypass (NCT NCT01026103)

NCT ID: NCT01026103

Last Updated: 2014-03-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2014-03-14

Participant Flow

thirty patients consented, 1 was excluded by physician for elevated liver function test; 1 was not considered enrolled as subject did not receive study device in error, leaving 28 enrolled subjects.

Participant milestones

Measure	Tri Staple This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Overall Study STARTED	30
Overall Study Consented	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Tri Staple This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Overall Study Physician Decision	1
Overall Study did not receive study device bc of error	1

Baseline Characteristics

Tri Staple Technology Stapler Used in Gastric Bypass

Baseline characteristics by cohort

Measure	Tri Staple n=29 Participants This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Age, Continuous	42.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Measure	Tri Staple n=28 Participants This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Proportion of Patients With an Uneventful Creation of a Functional Staple Line	28 participants Interval 88.0 to 100.0

SECONDARY outcome

Timeframe: Day 0 and 1 month

Outcome measures

Measure	Tri Staple n=28 Participants This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Incidence of Intra-operative Bleeding Requiring Intervention	19 participants Interval 48.0 to 84.0

SECONDARY outcome

Timeframe: Date of discharge which averages 3 days

Outcome measures

Measure	Tri Staple n=28 Participants This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Length of Hospital Stay	3.2 days Standard Deviation 0.5

SECONDARY outcome

Timeframe: 30 days post op

Outcome measures

Measure	Tri Staple n=28 Participants This is a single arm study. Tri Staple Technology stapler : This is a single arm study.
Incidence of Serosal Tearing	0 participants

Adverse Events

Tri Staple

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tri Staple n=28 participants at risk This is a single arm study.
Gastrointestinal disorders Stricture	7.1% 2/28 • Number of events 2 • 30 days post surgery
Gastrointestinal disorders GI Bleed	3.6% 1/28 • Number of events 1 • 30 days post surgery

Other adverse events

Measure	Tri Staple n=28 participants at risk This is a single arm study.
Gastrointestinal disorders Bloating	7.1% 2/28 • Number of events 2 • 30 days post surgery
Surgical and medical procedures Blood Loss	7.1% 2/28 • Number of events 2 • 30 days post surgery
Metabolism and nutrition disorders Dehydration	7.1% 2/28 • Number of events 2 • 30 days post surgery
Psychiatric disorders Depression	25.0% 7/28 • Number of events 7 • 30 days post surgery
Gastrointestinal disorders Diarrhea	7.1% 2/28 • Number of events 2 • 30 days post surgery
Skin and subcutaneous tissue disorders Edema	10.7% 3/28 • Number of events 3 • 30 days post surgery
General disorders Fatigue	67.9% 19/28 • Number of events 19 • 30 days post surgery
Cardiac disorders Hypertension	7.1% 2/28 • Number of events 2 • 30 days post surgery
Infections and infestations Infection	10.7% 3/28 • Number of events 3 • 30 days post surgery
General disorders Nausea	50.0% 14/28 • Number of events 14 • 30 days post surgery
Surgical and medical procedures Pain	35.7% 10/28 • Number of events 10 • 30 days post surgery
Gastrointestinal disorders Ulcer	7.1% 2/28 • Number of events 2 • 30 days post surgery
General disorders Vomitting	21.4% 6/28 • Number of events 6 • 30 days post surgery
Gastrointestinal disorders Constipation	64.3% 18/28 • Number of events 18 • 30 days post surgery

Additional Information

Noreen Fahey

Covidien

Phone: 203-821-4716

Email: noreen.fahey@covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place