Roux En Y Gastric Bypass
Conditions
Brief summary
The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
Interventions
DEVICEDuet TRS
Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The patient must be 18-65 years of age. * The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities * The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
Exclusion criteria
* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc) * The patient is pregnant. * The patient has an active, or history of, infection at the operative site. * The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent. * Patient has an abdominal ventral hernia * The patient has a history of liver disease * The patient has a history of drug or alcohol abuse * The patient has a history of venous thrombosis or pulmonary embolism * The patient has a history of coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events. | Day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Room (OR) Time | Day 0 | OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port. |
| Length of Hospital Stay | Day 2 (Approximately 1.5 days post randomization) | Days spent in the hospital |
| Incidence of Stapler 'Misfires' | Day 0 | The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth. |
Countries
United States
Participant flow
Recruitment details
Between November 24, 2009 and March 29, 2010, a total of 29 patients were consented and screened for potential study participation at one institution (Duke University). Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
Pre-assignment details
Subjects were evaluated for pre-operative and intra-operative eligibility criteria prior to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Duet TRS Subjects receive Duet TRS
Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not have surgery | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Duet TRS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 2 / 27 |
Outcome results
Primary
Incidence of Adverse Events.
Time frame: Day 30
Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duet TRS | Incidence of Adverse Events. | 6 adverse events |
Secondary
Incidence of Stapler 'Misfires'
The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.
Time frame: Day 0
Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duet TRS | Incidence of Stapler 'Misfires' | 3 participants |
Secondary
Length of Hospital Stay
Days spent in the hospital
Time frame: Day 2 (Approximately 1.5 days post randomization)
Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duet TRS | Length of Hospital Stay | 1.5 days | Standard Deviation 0.6 |
Secondary
Operating Room (OR) Time
OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.
Time frame: Day 0
Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duet TRS | Operating Room (OR) Time | 98 minutes | Standard Deviation 27 |