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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.
West Virginia University
Morgantown, West Virginia, United States
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.
Time frame: Day 1- At time of procedure
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.
Time frame: Day 1- At time of procedure
Incidence of Trocar-Related Complications
The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery.
Time frame: 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.
Time frame: Day 1- At time of procedure
Frequency of Trocar Upsizing
The percentage of trocar insertions requiring upsizing.
Time frame: 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.
Time frame: 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.
Time frame: Day 1- At time of procedure
Total Procedure Time
Total time (in minutes) from insufflation and trocar insertion to completion of the surgical procedure.
Time frame: Day 1- At time of procedure
Postoperative Analgesic Use
Percentage of participants reporting postoperative analgesic consumption.
Time frame: Up to 72 hours post procedure
Time to Return to Normal Activity
Number of days until return to work or normal activity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 72 hours post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.