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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xpan Trocar System | Active Comparator | Participants will undergo laparoscopic surgery using the Xpan Trocar System. Standard insertion technique will be used to create a 3 mm punch into an already gas-extended abdomen. A total of 3-5 trocars will be placed based on the type of surgery. Once placed, trocars will be radially dilated to the size necessary for the procedure, generally 2 trocars expanded to 5 mm and 2 trocars expanded to 12 mm. Final trocar size will range from 3 mm to 12 mm. Both placement and final dilated size will be documented. |
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| Standard of Care (Non-expanding Trocar) | Placebo Comparator | Participants will undergo laparoscopic surgery using a non-expanding trocar, which is considered the institutions standard of care for the procedure. Trocar size is selected based on surgical requirements and remain fixed throughout the procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpan Trocar System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Trocar slippage and Displacement | Percentage of trocars inserted for use during surgery that need to be adjusted or reinserted during surgical procedure due to slippage and/or displacement. | Day 1- At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Cases Without Fascial Closure at 12 mm Sites | The proportion of surgical cases where fascial closure was not required at 12 mm trocar sites. | Day 1- At time of procedure |
| Incidence of Trocar-Related Complications |
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Inclusion Criteria:
Individuals scheduled for the following procedures:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Tabone, MD | Contact | 304-293-1728 | letabone@hsc.wvu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lawrence Tabone, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
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| Standard of Care (Non-expanding Trocar) | Device | A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice. |
|
The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery.
| Day 1- At time of procedure |
| Ease of Use of Expansion Technique | 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. | Day 1- At time of procedure |
| Frequency of Trocar Upsizing | The percentage of trocar insertions requiring upsizing. | Day 1- during procedure |
| Surgeon reported Ease of Trocar Upsizing | The surgeon-reported ease of upsizing, rated on a 1-5 Likert scale (1 = difficult, 5 = easy) with 5 being the best outcome. | Day 1- during procedure |
| Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing | Percentage of successful maintenance of abdominal pathway and pneumoperitoneum during trocar upsizing. | Day 1- At time of procedure |
| Total Procedure Time | Total time (in minutes) from insufflation and trocar insertion to completion of the surgical procedure. | Day 1- At time of procedure |
| Postoperative Analgesic Use | Percentage of participants reporting postoperative analgesic consumption. | Up to 72 hours post procedure |
| Time to Return to Normal Activity | Number of days until return to work or normal activity. | 6 weeks post procedure |
| Postoperative Pain Scores | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. | 4 hours post procedure |
| Postoperative Pain Scores | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. | 8 hours post procedure |
| Postoperative Pain Scores | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. | 12 hours post procedure |
| Postoperative Pain Scores | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. | 24 hours post procedure |
| Postoperative Pain Scores | Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome. | 72 hours post procedure |