Characterizing Stray Energy Injuries During Robotic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Port-site Injury Caused by Stray Energy Transfer
• Intervention / Treatment: Procedure: Laparoscopic robotic DaVinci assisted inguinal hernia repair; Procedure: Standard laparoscopic inguinal hernia repair

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80016
      • RMR Denver VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients will be recruited in the general surgery clinic once the presence of an operable, inguinal hernia has been identified.
• All patients with a unilateral, symptomatic, inguinal hernia, and
• Who are surgical candidates for a laparoscopic inguinal hernia repair.

Exclusion Criteria:

• Under 18 years,
• Emergent hernia repairs,
• Recurrent hernias,
• Bilateral hernias, and
• Incarcerated bowel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic robotic DaVinci assisted inguinal hernia repair; Intervention: 30 patients will undergo a robotic assisted laparoscopic inguinal hernia repair. This will be done using the DaVinci Robotic Platform by Intuitive Surgical. This an accepted safe method of repairing inguinal hernia. This platform uses special robotic ports produced and supplied by Intuitive Surgical required to dock the machine to the patient. Monopolar energy will be provided by a ForceTriad system (Covidien, Boulder, CO), standard an common system used in most ORs. This will be used for dissection. The investigators will obtain small biopsies from port site to assess stray energy transfer injury, a model described by earlier studies.	Procedure: Laparoscopic robotic DaVinci assisted inguinal hernia repair; Laparoscopic inguinal hernia repair using a robotic assisted laparoscopic procedure.; Other Names: Dissection use of monopolar energy provided bt ForceTriad System (Covidien)
Active Comparator: Standard Laparoscopic inguinal hernia repair; Intervention: 30 patients will undergo a laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia. This platform uses standard laparoscopic ports. In our institution we use plastic ports made by Covidien, Boulder, CO. The operation will require two 5mm VersaPort (Covidien) and a Hassan Port. As in the robotic arm, monopolar energy will be provided by a ForceTriad system (Covidien, Boulder, CO), standard an common system used in most ORs. This will be used for dissection. The investigators will obtain small biopsies from port site to assess stray energy transfer injury, a model described by earlier studies.	Procedure: Standard laparoscopic inguinal hernia repair; Laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia.; Other Names: Dissection use of monopolar energy provided by ForceTriad System (Covidien)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic analysis of port-site skin biopsies	Samples will be taken at the time of surgery from each of the three ports and analyzed by a board certified pathologist to assess for injury on histologic level.	Biopsies will be taken right away and analysed within 1-2 weeks.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Krzysztof Wikiel, MD, ECHCS/Denver VA

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 18-0527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No