Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled

Summary

Minimal invasive surgery has acquired increased importance and the number of procedures performed is ever growing. Laparoscopic surgery has several distinct key benefits for patients over open surgery and therefore it is considered as standard treatment for most general surgery procedures. These benefits include faster recovery, shorter hospital stay, reduced post-operative pain and improved cosmetic results.

However, laparoscopy has an increased burden to surgeons and many surgeons experience fatigue and physical discomforts due to laparoscopy. Robotic systems have been developed to improve the ergonomics (among other things), with good results. Many of the laparoscopy disadvantages have been overcome by robotic assisted surgery, such as increased range of motion, correction of the inverted instruments, and elimination of tremors.(4) Moreover, visualization of the operation is improved by personal camera control and stabilization of the image.

The AutoLap system, a video analytic robotic camera holder, has been developed to hold the camera in a stable manner. It enables the surgeon to control the camera and eliminates the need for coordination and communication between surgeon and assistants.

This study aims to evaluate the ergonomics of the surgeon and assistant during laparoscopy with the aid of the AutoLap system and compare it to standard laparoscopy. Also, it will be assessed whether the AutoLap can reduce physical and mental discomfort of both the surgeon and the assistant.

Objective This multicenter randomized controlled trial aims to compare ergonomics of the OR nurse and the surgeon during standard laparoscopic procedures with laparoscopic procedures aided by a robotic camera holder, the AutoLap system.

Study design Prospective, interventional, open, multicenter randomized controlled trial. The study will be conducted in Wilhemina Hospital Assen and in Meander Medical Center Amersfoort.

Study population

Adults ≥18 years who are scheduled for the following procedures:

* Laparoscopic hiatal hernia repair / fundoplication
* Laparoscopic right hemicolectomy
* Laparoscopic sigmoid resection
* Laparoscopic rectopexy
* Laparoscopic low anterior resection
* Laparoscopic splenectomy

Inclusion criteria

1. Aged ≥ 18 years
2. Fit for standard laparoscopic general surgery

Exclusion criteria

1. Contra-indications for laparoscopy
2. Obesity (BMI \>35 Kg/m2)

Intervention AutoLap group: In the AutoLap group, the camera will be held by a robotic arm. Posture of the surgeon and the assistant will be recorded during standardized predefined steps of the procedure.

Control group: In the control group the camera will be held and maneuvered by a human assistant. The procedures will be performed according to the hospital and OR routine procedure. The surgical team will consist of 2 assistants and a surgeon. One of the assistants (OR-nurse, intern or resident) will hold the laparoscope and maneuver it. Posture of the surgeon and the assistant that maneuvers the laparoscope will be recorded during standardized predefined steps of the procedure.

Main study parameters/endpoints:

\- RULA score, measured during predefined steps of the procedures.

Secondary parameters/endpoints:

\- Questionnaires: Subjective Mental Effort Questionnaire (SMEQ), Local Experienced Discomfort (LED) scale (before and after the operation), NASA Task Load Index (NASA TLX).

Conditions

• Ergonomics

Interventions

OTHER

Ergonomic measurement

Ergonomic measurement of the surgeon and assistant

Sponsors & Collaborators

• Wilhemina Ziekenhuis Assen

  collaborator UNKNOWN

• Meander Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-23

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• Netherlands

Study Locations