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Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339960
Recruitment Status : Unknown
Verified November 2017 by Paul Wijsman, Meander Medical Center.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Wilhemina Ziekenhuis Assen
Information provided by (Responsible Party):
Paul Wijsman, Meander Medical Center

Brief 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).


Condition or disease Intervention/treatment Phase
Ergonomics Other: Ergonomic measurement Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ergonomics of Laparoscopy: Robotic Camera Controlled Versus Human Camera Controlled - A Randomized Controlled Trial
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ergonomics

Arm Intervention/treatment
Active Comparator: Robotic camera controlled Other: Ergonomic measurement
Ergonomic measurement of the surgeon and assistant

Active Comparator: Human camera controlled Other: Ergonomic measurement
Ergonomic measurement of the surgeon and assistant




Primary Outcome Measures :
  1. Mean Rapid Upper Limb Assessment score [ Time Frame: Measured during predefined steps of the procedures ]
    Range: 1-7


Secondary Outcome Measures :
  1. Mean Subjective Mental Effort Questionnaire [ Time Frame: Directly after the surgery ]
    Range: 0-150

  2. Mean Local Experienced Discomfort scale [ Time Frame: Before and directly after the surgery ]
    Range: 0-10 per body part

  3. Mean NASA Task Load Index [ Time Frame: Directly after the surgery ]
    Range: 1-21 per dimension (7 in total)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339960


Contacts
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Contact: Paul Wijsman, MD +31338505050 pjm.wijsman@meandermc.nl
Contact: Ivo Broeders +31338505050

Locations
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Netherlands
Meander Medical Center Recruiting
Amersfoort, Netherlands
Wilhemina Ziekenhuis Assen Recruiting
Assen, Netherlands
Sponsors and Collaborators
Meander Medical Center
Wilhemina Ziekenhuis Assen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Wijsman, Study coordinator, Meander Medical Center
ClinicalTrials.gov Identifier: NCT03339960    
Other Study ID Numbers: NL61977.100.17
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No