Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05116332 |
| Other study ID # |
FHMREC20033 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 11, 2021 |
| Est. completion date |
March 10, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Lancaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators postulate that there is a difference in the acquisition of Fundamental
Laparoscopic Skills (FLS) between general surgical and Obstetrics & Gynaecology (O&G)
trainees. This discrepancy is also likely to influence the musculoskeletal and cognitive
fatigue trainees experience within both specialties.
Additionally there is likely to be a discrepancy in the expectations of consultants and
trainees on skills perceived to be important at the completion of training (CCT).
This study aims to compare and evaluate the discrepancy in FLS acquisition amongst O&G and GS
trainees in order to identify areas for improvements in the training pathway, the associated
fatigue experience and highlight the expectations perceived to be required at the completion
of training.
Description:
Laparoscopic surgery (LS) is widely used for an increasing number of procedures in general
surgery and obstetrics and gynecology (O&G). However, the psychomotor skills of laparoscopic
surgery can be difficult to develop and trainees pursuing a laparoscopic surgical career
often face a steep learning curve. Whilst simulation based training can lead to acquisition
of transferrable skills, they are not a substitute for the operating theatre.
In both specialties, obtaining adequate exposure to operative work is a multifaceted
challenge for the trainees as well as those involved in designing and delivering surgical
training. Amongst other factors, NHS pressures driving service provision, European Working
Time Directive (EWTD), loss of firm structures, and the cost of training to the trainees
themselves have been identified as factors affecting the quality of surgical training in the
UK. This is reflected in annual training surveys highlighting concerns over loss of practical
training and experience across both specialties.
Whilst the requirements for CCT for general operative skills in open and laparoscopic surgery
are comparable in both specialties, the training pathways defer significantly. GS training is
8 years in duration (CT1, CT2, ST3-ST8), whereas O&G consists of 7 years of specialty
training (ST1-ST7). The ST1-ST5 years in O&G is mainly devoted to obstetrics and only those
trainees pursuing a gynaecological training pathway undertake an intensive period of surgical
training in the last two years of their training. The investigators believe there is also
earlier exposure to laparoscopy in GS training with a greater volume of laparoscopic work in
comparison to O&G training.
So far there is no direct comparison of O&G and GS training pathways and outcomes in
laparoscopic skills.
It is known that greater exposure to laparoscopic training is associated with "muscle memory"
and may contribute to reducing the physical and mental stress of the surgeon. The
investigators would expect trainees to be more efficient at FLS with more laparoscopic
surgery exposure. The measurement of muscular and cognitive fatigue can be regarded as a
surrogate marker of exposure to laparoscopy giving further insights into the quality of
laparoscopic training between the two training programs.
There is currently no literature to highlight expectations and opinions of consultants or
programme directors regarding trainees' skills within GS or O&G in the UK, which the
investigators believe to be one of the indicators of training standards.
The objectives of the study include; To compare FLS in O&G and GS trainees at ST3/4/5 and
those in their final 2 years [ST7/8(GS) and ST6/7 (O&G)], To compare the musculoskeletal and
cognitive fatigue experienced by O&G and GS trainees in performing FLS as a marker of their
competence, and to compare the standards of laparoscopic ability expected from trainees by
experienced GS and gynecological consultants.
Study design:
This is a prospective comparative study and the investigators will recruit participants from
professional membership bodies and the North West health education formerly known as the
North West deanery. The study is divided into two parts. In part 1, Consultants and trainees
from O&G and GS specialties will be contacted electronically through professional membership
bodies (O&G consultants through RCOG/BSGE, GS consultants through ASGBI, O&G trainees through
RCOG/BSGE, and GS trainees through ASiT). In addition to the above communication methods, the
investigators will consider the use of social media and direct emails to increase the survey
response rate. The consultants and trainees will be requested to fill out an online short
questionnaire designed to assess trainees perceptions of FLS required at CCT and the
consultants' expectations of laparoscopic competencies required by trainees at CCT. These
surveys will not include any personal details and will be returned anonymously to the
investigators via the survey monkey platform. In the second part, the investigators will
recruit trainees from the two specialties via the North West deanery by sending out a
centralized email requesting them to volunteer for the FLS tasks. In addition to the above
recruitment methods, the investigators will consider the use of social media and direct
emails to increase trainee recruitment for the study. Trainees will be able to volunteer
their help by replying to a secure email address. Those trainees who respond and meet the
inclusion criteria will subsequently be invited to attend a study day to perform four FLS
tasks with a choice of 6 days across 3 possible weekends.
On the day, trainees will be asked to fill out another short questionnaire to gather some
demographic information and account for potential confounding variables. Personal details
from these questionnaires will be separated and a study number will be randomly allocated to
both parts of the questionnaires and this number will be written on the trainee's badge which
will be used for filling out the task evaluation sheets. A single sheet of paper will allow
the investigators recognize the study number against the relevant trainee in case there is a
need to contact them at some point. This form will be securely stored in a locked cabinet in
an NHS locked office accessible only to the research team.
A sub-selection of trainees will be randomly chosen to have an electromyography (EMG) and
electroencephalography (EEG) monitoring whilst performing the tasks.
There are four FLS tasks and they are carried out using validated training models called
LASTT (Laparoscopic Skills Training and Testing method) and SUTT-1 (Suturing and knot tying
Training and Testing method). LASTT is a wooden model and SUTT-1 is a foam sponge. The tasks
are:
1. Laparoscopic Camera Navigation; Laparoscopic camera navigation (LCN) assesses the
trainee's ability to navigate a 30 degrees camera using either their dominant hand (DH)
or their non-dominant hand (NDH). The task requires the trainee to insert a 10mm 30
degrees optic through the central port of the Szabo box trainer. 14 targets will be
dispersed around the LASTT model. Each target contains a large size character (either a
large number or a large alphabet letter) and a small size character (either a number or
an alphabet letter). The large character can be seen from a panoramic field but the
smaller character requires the trainee to zoom in. The trainees will be required to
sequentially locate all targets whilst being timed.
2. Hand-eye coordination (HEC); To assess HEC, trainees are assessed on their ability to
transfer objects as well as navigate the camera. The trainee is expected to use the
dominant hand (DH) to hold grasping forceps and the non-dominant hand (NDH) to hold the
camera. The LASTT model will be used to assess this. There will be coloured cylinders of
different colours, which the trainees will be required to place in corresponding
coloured targets nails.
3. Bimanual co-ordination (BMC); BMC is assessed by measuring the time taken for a trainee
to transfer 6 objects between their DH and NDH and position them correctly on the LASTT
model. Coloured pins will be transferred from a central location to the corresponding
coloured targets. The trainees are expected to identify a coloured pushpin (e.g. red),
grasp it by the head with grasping forceps(Johans) using their NDH, then transfer the
pin to their DH and grasp the pin by its tail using curved forceps like Maryland. The
pushpin then needs to be placed in the corresponding disc of the same colour correctly
before moving on to the next coloured pushpin.
4. Suturing and knot placement; All trainees will be shown a video demonstration of
laparoscopic suturing and intra-corporeal knotting.
A Suturing and knot tying Training and Testing method (SUTT1) foam pad will be used for
assessment of suturing and knot placement. This has 5 rows of dots. For this task, the top 4
rows are used and the 5th row is disregarded. Trainees will be expected to place interrupted
sutures between two dots and perform 4 intracorporeal knots with 3 throws. A total of 15
minutes will be allowed for this task and the time taken to complete 4 sutures and 4 knots if
performed will be recorded. If the trainee runs out of time, then a total number of sutures
+/- knots performed within the 15 minutes will be recorded.
Measurement of EMG and EEG; A random selection of trainees will have wireless
electromyography (EMG) and electroencephalography (EEG) monitoring whilst performing the
above tasks. As the equipment is wireless, it is anticipated that the trainee's freedom of
movement will not be affected by it. EMG activity will be measured in the arm, shoulder,
upper and lower back muscles, and the EEG activity of interest will be the alpha wave pattern
observed during the activities.
