Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale Clinical Trial
Official title:
Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
| Verified date | February 2021 |
| Source | Lexington Medical Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 14, 2020 |
| Est. primary completion date | January 24, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Avala Hospital | Covington | Louisiana |
| United States | Crescent City Surgical Centre | Metairie | Louisiana |
| United States | Southern Surgical Hospital | Slidell | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Lexington Medical Inc. | Surgical Specialists of Louisiana |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) | 10 seconds after last staple line | |
| Secondary | Staple Line Leaking | Incidence of postoperative leakage during one-month monitoring period following procedure | 1 month following procedure | |
| Secondary | Adverse Events | Incidence of reported device-related adverse events | 1 month following procedure | |
| Secondary | Product Malfunction | Incidence of product malfunction during procedure | During surgery | |
| Secondary | Blood Transfusion | Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time | Within 72 hours of surgery start | |
| 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. | 1 week following procedure |