Characterizing Stray Energy Injuries During Robotic Surgery

NCT ID: NCT03477201

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-04-01

Brief 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.

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.

Conditions

Port-site Injury Caused by Stray Energy Transfer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laparoscopic robotic DaVinci assisted inguinal hernia repair

Intervention Type: PROCEDURE

Laparoscopic inguinal hernia repair using a robotic assisted laparoscopic procedure.

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.

Group Type: ACTIVE_COMPARATOR

Standard laparoscopic inguinal hernia repair

Intervention Type: PROCEDURE

Laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia.

Interventions

Laparoscopic robotic DaVinci assisted inguinal hernia repair

Laparoscopic inguinal hernia repair using a robotic assisted laparoscopic procedure.

Intervention Type: PROCEDURE

Standard laparoscopic inguinal hernia repair

Laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia.

Intervention Type: PROCEDURE

Other Intervention Names

Dissection use of monopolar energy provided bt ForceTriad System (Covidien); Dissection use of monopolar energy provided by ForceTriad System (Covidien)

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krzysztof Wikiel, MD

Role: PRINCIPAL_INVESTIGATOR

ECHCS/Denver VA

Locations

RMR Denver VA

Aurora, Colorado, United States

Countries

United States

Other Identifiers

18-0527

Identifier Type: -

Identifier Source: org_study_id