Larsen 2009.
Methods | Randomised clinical trial. | |
Participants | Country: Denmark.
Number randomised: 24.
Postrandomisation drop‐outs: 3 (12.5%).
Revised sample size: 21.
Average age: 33 years.
Women: 22 (91.7%). Inclusion criteria: 1. Trainees in gynaecological specialty training years 1 and 2 with no experience of advanced laparoscopy (defined as all laparoscopic procedures involving co‐ordination of more than 1 instrument). |
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Interventions | Participants were randomly assigned to two groups.
Group 1: virtual reality training (n = 11).
Group 2: no supplementary training (n = 10). Details of virtual reality training: 1. LapSim Gyn 3.0.1. 2. Training in the 2 basic skills of “lifting and grasping” and “cutting” and one procedure‐specific task in which the trainee had to carry out a complete right‐sided salpingectomy while preserving the ovary. 3. The training in basic skills was done once in each training cycle of 45 ‐ 60 minutes and the salpingectomy repeated continually during the remainder of the cycle. 4. The simulator provided the trainees with instant feedback on time, path length and angular path of the instruments’ movements, bleeding, cutting of uncoagulated arteries, and use of diathermy on non‐target tissue. 5. The training sessions were repeated until the expert criterion level was reached in 2 consecutive and independent simulations. |
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Outcomes | The outcomes reported were operating time and operative performance. | |
Notes | Assessment: Surgical performance during elective laparoscopic salphingenctomy. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The Clinical Trial Unit at Copenhagen University independently randomised the trainees by computer to intervention or control groups." |
Allocation concealment (selection bias) | Low risk | Quote: "The randomisation procedure was concealed and achieved by using the trainees’ unique personal identification number". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "it was not possible to blind the trainees to their allocated group, but all involved departments, supervisors, and staff in the operating theatres were blinded to the trainee’s group". Comment: It is impossible to blind the participants to the groups. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All involved departments, supervisors, and staff in the operating theatres were blinded to the trainee’s group, and the assessors of outcome were blinded to both the trainee and their allocated group." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: There were postrandomisation drop‐outs. |
Selective reporting (reporting bias) | Low risk | Comment: All important outcomes were reported. |
Source of funding bias | Low risk | Quote: "This project was supported by Copenhagen University Rigshospitalet Hospital. Trygfondet supplied various materials including computer hardware. Det Calssenske Fidecommis’ Jubilaeumsfond provided travel expenses. Aase and Ejner Danielsens foundation provided software maintenance and updates, DVD recorders, and a TV monitor. The Danish Society for the Protection of Laboratory Animals provided computer hardware and software. All phases of the present work including design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the final manuscript were done independent of the funders." Comment: Funded by various organisations which do not appear to have a vested interest in the results of the trial |