Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Conditions
Brief summary
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
Interventions
DEVICEAEON Endostapler
Surgery with AEON Endostapler
DEVICEEchelon Flex Powered Stapler
Surgery with Echelon Flex Powered Stapler
Sponsors
Surgical Specialists of Louisiana
Lexington Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form * Informed consent for study obtained and signed from each subject
Exclusion criteria
* Planned open surgical approach * Prior bariatric operation (i.e. revisional bariatric surgery) * Use of staple line reinforcement material (buttress) * Patients taking anticoagulants * Patients under the age of 18 on the date of the surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staple Line Bleeding | 10 seconds after last staple line | Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staple Line Leaking | 1 month following procedure | Incidence of postoperative leakage during one-month monitoring period following procedure |
| Adverse Events | 1 month following procedure | Incidence of reported device-related adverse events |
| Product Malfunction | During surgery | Incidence of product malfunction during procedure |
| Blood Transfusion | Within 72 hours of surgery start | Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time |
| Pain Level | 1 week following procedure | Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AEON Endostapler Stapling performed by AEON Endostapler
AEON Endostapler: Surgery with AEON Endostapler | 30 |
| Echelon Flex Powered Stapler Stapling performed by Echelon Flex Powered Stapler
Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | AEON Endostapler | Echelon Flex Powered Stapler | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11 | 45 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 11 |
| BMI | 44 kg/m^2 STANDARD_DEVIATION 6 | 46 kg/m^2 STANDARD_DEVIATION 7 | 45 kg/m^2 STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 25 Participants | 43 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Staple Line Bleeding
Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)
Time frame: 10 seconds after last staple line
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Staple Line Bleeding | 2.08 score on a scale | Standard Deviation 0.98 |
| Echelon Flex Powered Stapler | Staple Line Bleeding | 2.57 score on a scale | Standard Deviation 1.13 |
p-value: 0.01t-test, 2 sided
Secondary
Adverse Events
Incidence of reported device-related adverse events
Time frame: 1 month following procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEON Endostapler | Adverse Events | Yes | 0 Participants |
| AEON Endostapler | Adverse Events | No | 30 Participants |
| Echelon Flex Powered Stapler | Adverse Events | Yes | 0 Participants |
| Echelon Flex Powered Stapler | Adverse Events | No | 30 Participants |
Secondary
Blood Transfusion
Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time
Time frame: Within 72 hours of surgery start
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEON Endostapler | Blood Transfusion | Yes | 0 Participants |
| AEON Endostapler | Blood Transfusion | No | 30 Participants |
| Echelon Flex Powered Stapler | Blood Transfusion | Yes | 0 Participants |
| Echelon Flex Powered Stapler | Blood Transfusion | No | 30 Participants |
Secondary
Pain Level
Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain.
Time frame: 1 week following procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Pain Level | 1.8 score on a scale | Standard Deviation 2.9 |
| Echelon Flex Powered Stapler | Pain Level | 1.6 score on a scale | Standard Deviation 2.7 |
Secondary
Product Malfunction
Incidence of product malfunction during procedure
Time frame: During surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEON Endostapler | Product Malfunction | Yes | 0 Participants |
| AEON Endostapler | Product Malfunction | No | 30 Participants |
| Echelon Flex Powered Stapler | Product Malfunction | Yes | 0 Participants |
| Echelon Flex Powered Stapler | Product Malfunction | No | 30 Participants |
Secondary
Staple Line Leaking
Incidence of postoperative leakage during one-month monitoring period following procedure
Time frame: 1 month following procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEON Endostapler | Staple Line Leaking | Yes | 0 Participants |
| AEON Endostapler | Staple Line Leaking | No | 30 Participants |
| Echelon Flex Powered Stapler | Staple Line Leaking | Yes | 0 Participants |
| Echelon Flex Powered Stapler | Staple Line Leaking | No | 30 Participants |