NCT03339960

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
  • Aged ≥ 18 years
  • Fit for standard laparoscopic general surgery
  • Contra-indications for laparoscopy
  • Obesity (BMI \>35 Kg/m2)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

November 7, 2017

Last Update Submit

November 9, 2017

Conditions

Ergonomics

Outcome Measures

Primary Outcomes (1)

  • Mean Rapid Upper Limb Assessment score

    Range: 1-7

    Measured during predefined steps of the procedures

Secondary Outcomes (3)

  • Mean Subjective Mental Effort Questionnaire

    Directly after the surgery

  • Mean Local Experienced Discomfort scale

    Before and directly after the surgery

  • Mean NASA Task Load Index

    Directly after the surgery

Study Arms (2)

Robotic camera controlled

ACTIVE COMPARATOR
Other: Ergonomic measurement

Human camera controlled

ACTIVE COMPARATOR
Other: Ergonomic measurement

Interventions

Ergonomic measurementOTHER

Ergonomic measurement of the surgeon and assistant

Human camera controlledRobotic camera controlled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Aged ≥ 18 years
  • \) Fit for standard laparoscopic general surgery

You may not qualify if:

  • \) Contra-indications for laparoscopy
  • \) Obesity (BMI \>35 Kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meander Medical Center

Amersfoort, Netherlands

RECRUITING

Wilhemina Ziekenhuis Assen

Assen, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30746574DERIVED

Central Study Contacts

Paul Wijsman, MD

CONTACT

+31338505050pjm.wijsman@meandermc.nl

Ivo Broeders

CONTACT

+31338505050

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 13, 2017

Study Start

June 23, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)