ErgonomicsNCT03339960
Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled
A study testing Ergonomic measurement in people with Ergonomics, run by Meander Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ergonomics
- What is being tested?
- Ergonomic measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Jun 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Aged ≥ 18 years
- 2) Fit for standard laparoscopic general surgery
Who cannot join
- 1) Contra-indications for laparoscopy
- 2) Obesity (BMI >35 Kg/m2)
Trial locations and contacts
2 sites in 1 country.
Ivo Broeders contact
Netherlands2 sites, 2 recruiting
- Recruiting
Meander Medical Center
Amersfoort
- Recruiting
Wilhemina Ziekenhuis Assen
Assen
About this study
Official title: Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled - A Randomized Controlled Trial
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.
Read more
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
- Aged ≥ 18 years
- Fit for standard laparoscopic general surgery
Exclusion criteria
- Contra-indications for laparoscopy
- 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).
Read the detailed description
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:
- Opening of pars flaccida
- Deperitonialisation of the crura
- Resection of the hernia sac
- Suturing of the crura
- Dissection of the vasa brevia (if applicable)
- Creation of the fundoplication
The defined steps for a right hemicolectomy are as follows:
- Mobilisation of the coecum
- Dissection Toldt's line (lateral mobilization)
- Making the Subcolic tunnel
- Dissection of the ileo-colic artery
- Dissection of gastrocolic ligament
- Mobilization of the transverse colon
- Making the anastomosis (if performed laparoscopically)
The defined steps for a sigmoid resection are as follows:
- Dissection Toldt's line (lateral mobilization)
- Exposing the ureter
- Colon descendens mobilisation
- Mobilisation of flexura lienalis
- Dissecting the mesocolon
- Making the anastomosis (if performed laparoscopically)
The defined steps for a rectopexy are as follows:
- Incision of peritoneum over the promotorium
- Posterior resection behind the rectum
- Dissection towards pelvic floor
- Anterior resection of peritoneum
- Fixation of the mesh
- Removal of excess mesh
- Closing the peritoneum
The defined steps for a splenectomy are as follows:
- Opening of lesser peritoneal sac
- Division of gastrosplenic ligament
- Division of splenocolic ligament
- Division of pancreaticosplenic ligament
- Division of the hilum (vein and artery)
- Posterior and lateral dissection
The defined steps for a low anterior resection are as follows:
- Mobilisation of the sigmoid
- Dissection of the inferior mesenteric vena and arteria
- Dissection of the posterior wall of the mesorectum
- Lateral dissection of the sigmoid / rectum (freeing left colonic gutter)
- Dissection of the anterior wall of the rectum
- Dissection of Waldeyer's fascia
- Division of the distal rectum
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.
- Conditions
- Ergonomics
- Being tested
- Ergonomic measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic measurementOther
Ergonomic measurement of the surgeon and assistant
| Study group | Role | What they receive |
|---|---|---|
| Robotic camera controlled | Active comparator | Not described Receives: Other: Ergonomic measurement |
| Human camera controlled | Active comparator | Not described Receives: Other: Ergonomic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Rapid Upper Limb Assessment score
Range: 1-7
Measured: Measured during predefined steps of the procedures
Secondary outcomes (3)
Mean Subjective Mental Effort Questionnaire
Range: 0-150
Measured: Directly after the surgery
Mean Local Experienced Discomfort scale
Range: 0-10 per body part
Measured: Before and directly after the surgery
Mean NASA Task Load Index
Range: 1-21 per dimension (7 in total)
Measured: Directly after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start23 Jun 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ErgonomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meander Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wilhemina Ziekenhuis Assen
- Responsible party
- Principal investigator, Paul Wijsman, Meander Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339960
- Sponsor's protocol ID
- NL61977.100.17
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wijsman PJM, Molenaar L, Van't Hullenaar CDP, van Vugt BST, Bleeker WA, Draaisma WA, Broeders IAMJ. Ergonomics in handheld and robot-assisted camera control: a randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3919-3925. doi: 10.1007/s00464-019-06678-1. Epub 2019 Feb 11.
PubMed 30746574
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03339960
- Acronym / sponsor ID
- NL61977.100.17
- Conditions
- Ergonomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meander Medical CenterUniversity, hospital or other
- Collaborators
- Wilhemina Ziekenhuis Assen
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Aged ≥ 18 years
- Fit for standard laparoscopic general surgery
Exclusion criteria
- Contra-indications for laparoscopy
- 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).
Detailed description
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:
- Opening of pars flaccida
- Deperitonialisation of the crura
- Resection of the hernia sac
- Suturing of the crura
- Dissection of the vasa brevia (if applicable)
- Creation of the fundoplication
The defined steps for a right hemicolectomy are as follows:
- Mobilisation of the coecum
- Dissection Toldt's line (lateral mobilization)
- Making the Subcolic tunnel
- Dissection of the ileo-colic artery
- Dissection of gastrocolic ligament
- Mobilization of the transverse colon
- Making the anastomosis (if performed laparoscopically)
The defined steps for a sigmoid resection are as follows:
- Dissection Toldt's line (lateral mobilization)
- Exposing the ureter
- Colon descendens mobilisation
- Mobilisation of flexura lienalis
- Dissecting the mesocolon
- Making the anastomosis (if performed laparoscopically)
The defined steps for a rectopexy are as follows:
- Incision of peritoneum over the promotorium
- Posterior resection behind the rectum
- Dissection towards pelvic floor
- Anterior resection of peritoneum
- Fixation of the mesh
- Removal of excess mesh
- Closing the peritoneum
The defined steps for a splenectomy are as follows:
- Opening of lesser peritoneal sac
- Division of gastrosplenic ligament
- Division of splenocolic ligament
- Division of pancreaticosplenic ligament
- Division of the hilum (vein and artery)
- Posterior and lateral dissection
The defined steps for a low anterior resection are as follows:
- Mobilisation of the sigmoid
- Dissection of the inferior mesenteric vena and arteria
- Dissection of the posterior wall of the mesorectum
- Lateral dissection of the sigmoid / rectum (freeing left colonic gutter)
- Dissection of the anterior wall of the rectum
- Dissection of Waldeyer's fascia
- Division of the distal rectum
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic camera controlled | Active comparator | Other: Ergonomic measurement |
| Human camera controlled | Active comparator | Other: Ergonomic measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Aged ≥ 18 years
- 2) Fit for standard laparoscopic general surgery
Key exclusion criteria (2 listed)
- 1) Contra-indications for laparoscopy
- 2) Obesity (BMI >35 Kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic measurementErgonomic measurement of the surgeon and assistant | Other | Human camera controlled, Robotic camera controlled |
Primary outcome
Mean Rapid Upper Limb Assessment score
Time frame: Measured during predefined steps of the procedures
Range: 1-7
3 secondary outcomes
Mean Subjective Mental Effort Questionnaire
Time frame: Directly after the surgery
Mean Local Experienced Discomfort scale
Time frame: Before and directly after the surgery
Mean NASA Task Load Index
Time frame: Directly after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Derived from this study: PubMed 30746574Wijsman PJM, Molenaar L, Van't Hullenaar CDP, van Vugt BST, Bleeker WA, Draaisma WA, Broeders IAMJ. Ergonomics in handheld and robot-assisted camera control: a randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3919-3925. doi: 10.1007/s00464-019-06678-1. Epub 2019 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivo Broeders contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic measurement in people with Ergonomics, run by Meander Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Wijsman, MD (+31338505050, pjm.wijsman@meandermc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Rapid Upper Limb Assessment score (time frame: Measured during predefined steps of the procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.