An interventional study of Ergonomic measurement in Ergonomics, sponsored by Meander Medical Center. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Meander Medical Center · Not applicable, Interventional, and Other
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:
Inclusion criteria
Exclusion criteria
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:
Secondary parameters/endpoints:
Objective:
It is our hypothesis that the ergonomics of the surgeon and his/her assistant will be improved with the aid of the AutoLap than without the aid of a robotic camera holder. Maintaining the same posture for a long period of time can lead to discomfort and fatigue of the surgeon and his/her assistant. Also, the space at the OR table is limited. Therefore, their body postures are sometimes awkward, unnatural and out of neutral position. With the aid of a robotic camera holder, we expect to minify this problem and improve ergonomics during laparoscopic operations.
The Autolap system is CE mark approved and is used frequently during laparoscopic operations. No patient characteristics and data will be recorded. The ethics committee MEC-U in Nieuwegein assessed this study and concluded that it does not fall under the scope of the WMO. Therefore this is non-WMO research.
The system shall be used in accordance with its cleared indication according to the clinical plan by clinical staff that has appropriate qualifications and training.
Predefined steps of the procedures:
The defined steps for a hiatal hernia repair / fundoplication are as follows:
The defined steps for a right hemicolectomy are as follows:
The defined steps for a sigmoid resection are as follows:
The defined steps for a rectopexy are as follows:
The defined steps for a splenectomy are as follows:
The defined steps for a low anterior resection are as follows:
Position and angles of the posture will be measured with MATLAB software. The posture of the surgeon and assistant will be photographed during the operation in two directions; from the side and from behind. These photographs will be used to calculate the RULA score. The RULA score is only measured during laparoscopic parts of the operation; if a part of the operation is performed open (not laparoscopically) RULA score will NOT be measured during the open part. No patient data or measurements will be acquired during this study. The positioning of the surgeon and operating assistant, operating table and OR monitors will be standardized for each type of procedure. Also, the placement of the monitors will be taken into account in such a way that a good ergonomic posture of the surgeon and assistant is ensured.
Meander Medical Center is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Ergonomic measurement
Other: Ergonomic measurement
Ergonomic measurement of the surgeon and assistant
Mean Rapid Upper Limb Assessment score
Range: 1-7
Time frame: Measured during predefined steps of the procedures
Mean Subjective Mental Effort Questionnaire
Range: 0-150
Time frame: Directly after the surgery
Mean Local Experienced Discomfort scale
Range: 0-10 per body part
Time frame: Before and directly after the surgery
Mean NASA Task Load Index
Range: 1-21 per dimension (7 in total)
Time frame: Directly after the surgery
Plan to share: No
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Meander Medical Center