Trial document





This trial has been registered retrospectively.
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  DRKS00004675

Trial Description

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Title

The impact on training results of assigning either one or two test persons to work stations in multimodal laparascopic training courses.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Minimally Invasive Surgery (MIS), and by consequence laparoscopy, has been established as the gold standard of many operations in modern visceral surgery, e.g. appendectomy and cholecystectomy, and is being applied in many other kinds of operations. The laparoscopic method uses small skin incisions to introduce operational instruments and a camera into the abdomen and to conduct the operation. The patient benefits from this procedure in terms of, among others, reduced post-operative pain and reduced consumption of analgesics, faster mobilisation, reduced risk of infection, and faster return to ordinary life including earlier leave from hospital. The cosmetic results are excellent due to minimal abdominal incisions and minimal entry sites for operational instruments. However, surgeons face higher psychomotor demands by comparison to procedures involving open incisions. Hence, regular and safe laparoscopic practice involving a specific training curriculum outside of the operating theatre is essential. To this end, the Heidelberg University Medical Centre established the MIS training centre which was equipped with different training devices enabling prospective surgeons to acquire the motor abilities and operational processes necessary before applying them to actual patients. Part of the training centre equipment is a box trainer which may be used to acquire basic skills in the use of operational instruments which may then be used to proceed to more complex operational sequences. Moreover, a virtual reality trainer produced by Simbionix (“Lap Mentor”) and functioning as a laparoscopic simulator enables both practicing basic skills and procedural steps in surgery, and learning how to conduct more complex operational sequences. Online practice programmes (webop.de, websurg.com) make for an additional method for learning laparoscopic operational skills. The study project single player vs. double player was developed by the MIS Department in the Centre for General, Visceral, and Transplantation Surgery in the Heidelberg University Medical Centre. This study offers voluntary laparoscopic training courses to medical students at Heidelberg University during clinical semesters. These courses are mainly directed at students undergoing their surgical education. Participants are being stratified according to sex and randomly allotted to three groups.

All participants are asked to take a look at the online practice programmes before being introduced to the virtual reality trainer. Thus, students can acquire theoretical knowledge regarding laparoscopic surgery and get to know the training devices. Thereafter, all participants take a baseline test at the virtual reality trainer, involving a basic skills test and a cholecystectomy test. After this test, participants are randomly allotted to the two training groups (groups 1 and 2) and to the control group.

Groups 1 and 2 consist of students who all participate in a prescribed multimodal training curriculum involving box and virtual reality trainers either individually (Group 1, Single Player) or in pairs (Group 2, Double Player). Note, that training in pairs involves less practice per individual participant since participant pairs are given the same practice time for each training device but ought to share it among the two of them. After the introduction and the baseline test, Groups 1 and 2 practice basic skills with the box trainer and virtual reality trainer, as well as practicing on a simulated laparoscopic cholecystectomy (LC) at the virtual reality trainer. At the end of the four-day training curriculum, Groups 1 and 2 have to take the post-test at the virtual reality trainer. The LC is practiced with a Pulsating Organ Perfusion Trainer (POP trainer) at a later point of time, involving a hepatobiliary organ (liver, gall bladder and bile ducts) cluster of a pig.

The control group does not participate in any practice exercises at first, but is given the same introduction and is asked to participate in the same tests. Hence, the control group is only taking the baseline test on the starting date of the study. The post-test at the virtual reality trainer and the LC at the POP trainer are being taken on a later date. The control group does however receive the same training involving the virtual realty and box trainers after the tests have been conducted. During all the introductions, tests, and during the entire laparoscopic training, all participants in the study are being instructed by professional staff of the MIS centre in a standardised way. The POP and box trainers are mechanical laparoscopic simulators which enable trainees to apply the motor and operational skills previously acquired in complete operations involving animal organs. The final cholecystectomy using the POP trainer and an animal organ represents the final test that is used to evaluate and compare the achievements of all participants on grounds of the standardised validated Assessment System (OSATS). The OSATS, consisting of two evaluative spectra, allows for an evaluation of the achievements and skills of the surgeon regarding the conduct of the surgery in general and specifically for the operation.

This study project is primarily directed at identifying whether it is better to undergo a specific laparoscopic training curriculum individually, or whether participants benefit from a team factor and mutual support if practicing in pairs. There is no comparable study extant in the literature. A secondary objective of the study is an analysis of the diverse individual and general factors of influence on laparoscopic training and test results.
The factors assessed include sex, personal characteristics, experience with video games, physical activity, spatial sense, vital signs, and anatomic knowledge of participants. Potential correlation between these parameters and the test and training results are being compared and assessed.

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Brief Summary in Scientific Language

Minimally Invasive Surgery (MIS), and by consequence laparoscopy, has been established as the gold standard of many operations in modern visceral surgery, e.g. appendectomy and cholecystectomy, and is being applied in many other kinds of operations. The laparoscopic method uses small skin incisions to introduce operational instruments and a camera into the abdomen and to conduct the operation. The patient benefits from this procedure in terms of, among others, reduced post-operative pain and reduced consumption of analgesics, faster mobilisation, reduced risk of infection, and faster return to ordinary life including earlier leave from hospital. The cosmetic results are excellent due to minimal abdominal incisions and minimal entry sites for operational instruments. However, surgeons face higher psychomotor demands by comparison to procedures involving open incisions. Hence, regular and safe laparoscopic practice involving a specific training curriculum outside of the operating theatre is essential. To this end, the Heidelberg University Medical Centre established the MIS training centre which was equipped with different training devices enabling prospective surgeons to acquire the motor abilities and operational processes necessary before applying them to actual patients. Part of the training centre equipment is a box trainer which may be used to acquire basic skills in the use of operational instruments which may then be used to proceed to more complex operational sequences. Moreover, a virtual reality trainer produced by Simbionix (“Lap Mentor”) and functioning as a laparoscopic simulator enables both practicing basic skills and procedural steps in surgery, and learning how to conduct more complex operational sequences. Online practice programmes (webop.de, websurg.com) make for an additional method for learning laparoscopic operational skills. The study project single player vs. double player was developed by the MIS Department in the Centre for General, Visceral, and Transplantation Surgery in the Heidelberg University Medical Centre. This study offers voluntary laparoscopic training courses to medical students at Heidelberg University during clinical semesters. These courses are mainly directed at students undergoing their surgical education. Participants are being stratified according to sex and randomly allotted to three groups.

All participants are asked to take a look at the online practice programmes before being introduced to the virtual reality trainer. Thus, students can acquire theoretical knowledge regarding laparoscopic surgery and get to know the training devices. Thereafter, all participants take a baseline test at the virtual reality trainer, involving a basic skills test and a cholecystectomy test. After this test, participants are randomly allotted to the two training gropus (groups 1 and 2) and to the control group.

Groups 1 and 2 consist of students who all participate in a prescribed multimodal training curriculum involving box and virtual reality trainers either individually (Group 1, Single Player) or in pairs (Group 2, Double Player). Note, that training in pairs involves less practice per individual participant since participant pairs are given the same practice time for each training device but ought to share it among the two of them. After the introduction and the baseline test, Groups 1 and 2 practice basic skills with the box trainer and virtual reality trainer, as well as practicing on a simulated laparoscopic cholecystectomy (LC) at the virtual reality trainer. At the end of the four-day training curriculum, Groups 1 and 2 have to take the post-test at the virtual reality trainer. The LC is practiced with a Pulsating Organ Perfusion Trainer (POP trainer) at a later point of time, involving a hepatobiliary organ cluster of a pig.

The control group does not participate in any practice exercises at first, but is given the same introduction and is asked to participate in the same tests. Hence, the control group is only taking the baseline test on the starting date of the study. The post-test at the virtual reality trainer and the LC at the POP trainer are being taken on a later date. The control group does however receive the same training involving the virtual realty and box trainers after the tests have been conducted. During all the introductions, tests, and during the entire laparoscopic training, all participants in the study are being instructed by professional staff of the MIS centre in a standardised way. The POP and box trainers are mechanical laparoscopic simulators which enable trainees to apply the motor and operational skills previously acquired in complete operations involving animal organs. The final cholecystectomy using the POP trainer and an animal organ represents the final test that is used to evaluate and compare the achievements of all participants on grounds of the standardised validated Assessment System (OSATS). The OSATS, consisting of two evaluative spectra, allows for an evaluation of the achievements and skills of the surgeon regarding the conduct of the surgery in general and specifically for the operation.

This study project is primarily directed at identifying whether it is better to undergo a specific laparoscopic training curriculum individually, or whether participants benefit from a team factor and mutual support if practicing in pairs. There is no comparable study extant in the literature. A secondary objective of the study is an analysis of the diverse individual and general factors of influence on laparoscopic training and test results.
The factors assessed include sex, personal characteristics, experience with video games, physical activity, spatial sense, vital signs, and anatomic knowledge of participants. Potential correlation between these parameters and the test and training results are being compared and assessed.

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Organizational Data

  •   DRKS00004675
  •   2013/06/11
  •   [---]*
  •   yes
  •   Approved
  •   S-334/2011, Amendment 07/05/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K80.0 -  Calculus of gallbladder with acute cholecystitis
  •   K80.2 -  Calculus of gallbladder without cholecystitis
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Interventions/Observational Groups

  •   Participants training alone.

    All participants are asked to take a look at the online practice programmes before being introduced to the virtual reality trainer. Thereafter, all participants take a baseline test at the virtual reality trainer, involving a basic skills test and a cholecystectomy test. After this test, participants are randomly allotted to the two training gropus (groups 1 and 2) and to the control group.

    Group 1 consist of students who all participate in a prescribed multimodal training curriculum involving box and virtual reality trainers individually (Single Player). After the introduction and the baseline test, Group 1 practice basic skills with the box trainer and virtual reality trainer, as well as practicing on a simulated laparoscopic cholecystectomy (LC) at the virtual reality trainer. At the end of the four-day training curriculum, Group 1 have to take the post-test at the virtual reality trainer. The LC is practiced with a Pulsating Organ Perfusion Trainer (POP trainer) at a later point of time, involving a hepatobiliary organ cluster of a pig.
  •   Participants training in pairs.

    All participants are asked to take a look at the online practice programmes before being introduced to the virtual reality trainer. Thereafter, all participants take a baseline test at the virtual reality trainer, involving a basic skills test and a cholecystectomy test. After this test, participants are randomly allotted to the two training gropus (groups 1 and 2) and to the control group.

    Group 2 consist of students who all participate in a prescribed multimodal training curriculum involving box and virtual reality trainers in pairs (Double Player). Note, that training in pairs involves less practice per individual participant since participant pairs are given the same practice time for each training device but ought to share it among the two of them. After the introduction and the baseline test, Group 2 practice basic skills with the box trainer and virtual reality trainer, as well as practicing on a simulated laparoscopic cholecystectomy (LC) at the virtual reality trainer. At the end of the four-day training curriculum, Group 2 (now separately) have to take the post-test at the virtual reality trainer. The LC is practiced with a Pulsating Organ Perfusion Trainer (POP trainer) at a later point of time, involving a hepatobiliary organ cluster of a pig.
  •   Control group.

    All participants are asked to take a look at the online practice programmes before being introduced to the virtual reality trainer. Thereafter, all participants take a baseline test at the virtual reality trainer, involving a basic skills test and a cholecystectomy test. After this test, participants are randomly allotted to the two training gropus (groups 1 and 2) and to the control group.

    The control group does not participate in any practice exercises at first, but is given the same introduction and is asked to participate in the same tests. Hence, the control group is only taking the baseline test on the starting date of the study. The post-test at the virtual reality trainer and the LC at the POP trainer are being taken on a later date. The control group does however receive the same training involving the virtual realty and box trainers after the tests have been conducted.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group), Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The main-objective criterion is the operative performance of the study participants during the final laparoscopic cholecystectomy based on the standardized validated OSATS-criteria. The operative performance of the study participants is measured by two scales. The scale "generic technical skills" covers a range from 6 (min) to 30 points (max). The maximal achievable score of "specific technical skills" is 70 points and the minimal score 14 points. Both scales will be evaluated separately. The OSATS-scores are based on a Gaussian distribution. The scale "specific technical skills" will be applied in a modified way in this study due to its specific circumstances. The criteria "incision & insertion of the port" and " extraction of the gallbladder" refer to surgeries on humans or on living animals and cannot be rated appropriately on the P.O.P.-trainer. Both are replaced by the criteria "knowledge of surgery specific aspects" and "quality of the final product".

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Secondary Outcome

The baseline- and post-test of the VR-trainer is used to demonstrate the differences in achievement between the individual groups with training (group 1/group 2) and without training (group 3).
In all groups, data are continuously being collected for each participant on basis of the multimodal standardized training curriculum designed by the Department of MIC. Each individual exercise in the box-trainer is recorded with respect to time and errors. The software of the VR-trainer allows continuous recording of various parameters, which are taken for every participant. Based on the data, learning curves can be displayed for all participants immediately .
Using questionnaires and tests various data are recorded for each participant. The questions relate to laparoscopic prior experience and leisure behavior in relation to physical activity and playing computer games and musical instruments. Other parameters such as personality traits and spatial awareness are also taken via questionnaires. Group 2 will receive an additional question in relation to the joint training. Based on the individual data collected, a correlation between the training and test results might be deduced which we will also analyse. The questionnaire allows for evaluation of the training devices and the e-learning instructional films.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/19
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Medicals students in their clinical stage of studies.

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Exclusion Criteria

Participation in another laparoscopic training courses before. Repeated assistance in laparoscopic operations, except for camera assistance

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg
    • Mr.  Felix  Nickel 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg
    • Mr.  PD Dr.med.  Beat  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Allgemein-,Viszeral- und Transplantationschirurgie Universität Heidelberg
    • Mr.  Felix  Nickel 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.