Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03477201 |
| Other study ID # |
18-0527 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2019 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Stray energy transfer during laparoscopic surgery is recognized as a cause of potentially
serious complications. This will be the first study to demonstrate clinical evidence of
tissue injury due to stray energy transfer during robotic surgery. This information can then
be used to define surgeon modifiable factors that can reduce the risk of patient injury. In
addition, these data can guide the development of future robotic and laparoscopic platforms.
Description:
BACKGROUND: Stray energy transfer from monopolar instruments during laparoscopic surgery is
recognized as a cause of potentially catastrophic complications. The investigators have
published multiple studies on the varied mechanisms of stray energy transfer during
laparoscopic procedures. In addition, a preliminary study by the investigators has confirmed
stray energy transfer during robotic surgery in an in vivo model. However, there are no data
available on the potential clinical impact of stray energy in robotic surgery. Furthermore,
there are no studies directly comparing stray energy transfer between laparoscopic and
robotic procedures.
PURPOSE: The purpose of this study is to assess for thermal injury due to stray energy
transfer during elective laparoscopic and robotic inguinal hernia repairs.
HYPOTHESIS: The Investigators hypothesize that thermal injury to the skin surrounding the
working ports occurs during robotic and laparoscopic procedures. Based on prior data, the
Investigators hypothesize these injuries will occur more frequently at the camera port during
laparoscopy, and at the assistant port during robotic surgery.
METHODS: The Investigators plan to conduct a prospective, randomized controlled trial of
patients undergoing elective laparoscopic or robotic unilateral inguinal hernia repair.
Patients will be randomized into two groups, with one group undergoing laparoscopic
transabdominal preperitoneal (TAPP) technique and a second group undergoing robotic inguinal
hernia repair (TAPP technique) with the Xi DaVinci System (Intuitive, Sunnyvale, CA). The
monopolar instrument will deliver via standard instruments on 30W coagulation mode
(ForceTriad electrosurgical generator, Covidien, Boulder, CO). At the completion of the
procedure, skin biopsies will be taken at each of the three port incisions. These samples
will be examined for visual and histologic evidence of thermal injury by a blinded
pathologist.
IMPORTANCE: This will be the first study to demonstrate clinical evidence of tissue injury
due to stray energy transfer during robotic surgery. The inclusion of a laparoscopic arm will
allow confirmation of prior study findings as well as direct comparison of stray energy
transfer in both modalities. This information can then be used to define surgeon modifiable
factors that can reduce the risk of patient injury. In addition, these data can guide the
development of future robotic and laparoscopic platforms.
