Bariatric Surgery Candidate
Conditions
Brief summary
A trocar is a surgical instrument with a sharp point and tube and is used to create endoscopic access in the abdomen or chest where endoscopic instruments can be entered & used in minimally invasive surgical procedures. Xpan has created an FDA Cleared radially dilating trocar (RDT) that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery. The purpose of this research protocol is to demonstrate that a new FDA Cleared Xpan® radially dilating trocar (RDT) system is at least, just as effective as the existing RDT trocar systems. The procedure will be performed using a radially dilating trocar that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery.
Interventions
DEVICEXpan Trocar System
A radially dilating trocar system intended to reduce incision trauma by gradually dilating tissue rather than cutting. Allows initial placement at 3 mm and expansion up to 12 mm as needed for surgical access.
DEVICEStandard of Care (Non-expanding Trocar)
A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Individuals scheduled for the following procedures: * Sleeve Gastrectomy * Bypass * Revision \& other bariatric procedures * Robotic procedures * Bariatric patients
Exclusion criteria
* Any individual not scheduled for the above procedure and/or does not meet the age requirments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Trocar slippage and Displacement | Day 1- At time of procedure | Percentage of trocars inserted for use during surgery that need to be adjusted or reinserted during surgical procedure due to slippage and/or displacement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cases Without Fascial Closure at 12 mm Sites | Day 1- At time of procedure | The proportion of surgical cases where fascial closure was not required at 12 mm trocar sites. |
| Incidence of Trocar-Related Complications | Day 1- At time of procedure | The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery. |
| Ease of Use of Expansion Technique | Day 1- At time of procedure | Surgeon-reported ease of use of the trocar expansion technique, rated on a 1-5 Likert scale (1 = difficult to use, 5 = easy to use) with 5 being the best outcome. |
| Frequency of Trocar Upsizing | Day 1- during procedure | The percentage of trocar insertions requiring upsizing. |
| Surgeon reported Ease of Trocar Upsizing | Day 1- during procedure | The surgeon-reported ease of upsizing, rated on a 1-5 Likert scale (1 = difficult, 5 = easy) with 5 being the best outcome. |
| Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing | Day 1- At time of procedure | Percentage of successful maintenance of abdominal pathway and pneumoperitoneum during trocar upsizing. |
| Total Procedure Time | Day 1- At time of procedure | Total time (in minutes) from insufflation and trocar insertion to completion of the surgical procedure. |
| Postoperative Analgesic Use | Up to 72 hours post procedure | Percentage of participants reporting postoperative analgesic consumption. |
| Time to Return to Normal Activity | 6 weeks post procedure | Number of days until return to work or normal activity. |
| Postoperative Pain Scores | 4 hours post procedure | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. |
Countries
United States
Contacts
CONTACTLawrence Tabone, MD
PRINCIPAL_INVESTIGATORLawrence Tabone, MD
West Virginia University
Outcome results
None listed