Health Condition 1: null- Morbid obesity and related diseases.
Conditions
Interventions
Intervention1: Intervention and comparator agent CONTROL ARM VERSUS PSDV ARM.: Intervention and comparator agent. In CONTROL ARM PSDV product will not be used, while in PSDV ARM, PSDV product will be
Sponsors
Synovis Surgical Innovations
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult males or females with a age between 18-75 yrs. 2.subject /LAR must be able to give written informed consent form. 3 Must have a BMI 32.5kg/m2 with one or more co morbidities or BMI 37.5kg/m2. 4. Must be willing and able to return for follow up visits. 5 Subject should be a good candidate for sleeve Gastrectomy.
Exclusion criteria
Exclusion criteria: 1.Subject must not have previous or known allergy or sensitivity to bovine products. 2. No previous abdominal history that could affect the outcome of the trial. 3. Uncontrolled Hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the staple line bleeds and staple line leaks associated with the use of PSDV as staple line reinforcement during LSG surgery versus a control group.Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the Operating room time and the number of clips and or sutures used to control bleeding in the PSDV group versus the control group.Timepoint: 18 months. | — |
Countries
India
Contacts
Public ContactDr Jayashree Todkar
consulting laparoscopic and bariatric surgeon
Outcome results
None listed