Feasibility and safety of a surgical training program in total laparoscopic hysterectomy: Results of a pilot trial

It is widely accepted total laparoscopic hysterectomy (TLH) and vaginal hysterectomy are less invasive procedures compared to total abdominal hysterectomy (TAH). However, rates of TAH remain unreasonably high.


INTRODUCTION
Hysterectomy is the most common gynaecological procedure, with an incidence ranging from 312 to 510 per 100 000 in developed countries. 1A hysterectomy can be completed via an open abdominal, vaginal or minimally invasive approach (laparoscopic, robotic).
1][12][13][14] Australian researchers surveyed over 2300 patients and found women followed their surgeons' advice on surgical approach and rarely sought a second opinion, which means change was unlikely to result based on consumer demands. 15 Australia, formal training in TLH has been available since 2012.

MATERIALS AND METHODS
The study protocol has been previously published. 17In brief, we piloted a surgical training program for practising O&Gs in four hospitals in Queensland, Australia, with data collection conducted between 28 June, 2016 and 30 June, 2020.The primary objective was to decrease the proportion of hysterectomies performed by TAH by 30%, in 75% of gynaecological surgeons.Secondary objectives included to decrease: (1) incidence of surgical adverse events in patients receiving a hysterectomy by 20%; (2) length of stay for patients requiring a hysterectomy by 20%; and (3) direct hospital costs for hysterectomy by 10%.
The 30% TAH reduction is based on published evidence from other countries and based on our own experience from a pilot study, where a 30% reduction would represent a clinically meaningful improvement, translating into improved patient health outcomes. 2,12,14is trial was approved by the Royal Brisbane and Women's Hospital Human Research Ethics Committee (Approval HREC/16/ QRBW/564) and received site-specific approval by all participating hospitals (NCT03617354).While not strictly following the step-wedge design envisioned originally, this pilot study nevertheless had a staggered rather than simultaneous entry into the intervention.Our study participants were 11 O&Gs who participated in the training intervention and 11 O&Gs who served as a contemporary observational control cohort, continuing their usual surgical approach (all provided written informed consent).As practising O&G surgeons were the research participants, all patients who received hysterectomy provided a standard of care consent for the hysterectomy.
We followed the Standards for Quality Improvement Reporting Excellence in Education (SQUIRE-EDU) reporting guidelines to report the outcomes of the trial. 18spitals, participating specialist trainees, and surgical mentors inclusion criteria are listed in Table S1.
At enrolment, participating specialist trainees were asked to complete a baseline questionnaire which included demographics, barriers to TLH, current self-reported proficiency at minimally invasive hysterectomy, and most preferred surgical approach.Selfreported questionnaires were collected via REDCap electronic data capture tools.
O&Gs were selected for the control group if they were screened and eligible for the training program, but not selected.
Controls provided data on their hysterectomies during the intervention period.
Patients were eligible as training cases if they were considered low risk, as measured by the SurgicalPerformance Risk of Surgical Complications app (RISC), 19 had a uterus size <10 weeks, no previous laparotomy, ≤2 previous caesarean sections, a reasonably mobile uterus, and not on blood thinning medication.

Surgical training program
Surgical training was delivered through a sequential process of preceptorship (conducted at the surgical mentor's hospital) and proctorship (conducted at the surgical trainee's hospital).All mentors were gynaecological oncologists (n = 2) or advanced pelvic surgeons (n = 2) and undertook the LAPCO Train the Trainers Course (LAPCO-TT) workshop. 16,20,21eceptorship was provided in two stages: Stage 1 involved a half-day workshop with lectures on steps of the TLH procedure by

Amendments to program
After the intervention commenced, we found due to the complexity of some surgical cases in the hospitals, it was necessary to include some patients who had greater risk scores.While low-risk patients were preoperatively screened, there were a small number of cases that were deemed higher risk only once the surgery had commenced (n = 6, 1.2%).For example, the uterus size was larger than expected.
Due to the move of one participating specialist trainee at the start of the training program, only one completed training in one hospital.This may have resulted in less opportunity for peer support after the training finished.However, overall trial procedure adherence rates by intervention and control participants were high and all but two participating specialist trainees completed all training days and data collection forms.We modified the intervention to reduce travel burden for the surgical mentor in one regional hospital where the intervention was delivered on two consecutive training days over five months instead of one day per month for ten months in the metropolitan hospitals, resulting in different lengths of time for intervention periods, which were adjusted for using Poisson regression modelling.

Statistical analysis
Descriptive statistical methods were used to summarise the participating hospital, participant and patient details.Data on the surgical procedure were captured through SurgicalPerformance including surgical approach, familiarity of the team, length of stay, readmission to theatre or hospital, whether the patient experienced an adverse event and specific type of adverse event.The surgical approach used prior to the intervention was obtained from past monthly surgery records for a minimum of six months for each hospital, with the same minimum period to record surgical approach during/after the training program.
The surgical approach data pre-, during, and post-intervention was used to determine the rate of TLH compared to other approaches.This was done using a Poisson regression model, which accounts for: (i) different numbers of overall procedures during each time period; and (ii) length of time of pre-, during, and post-intervention periods.
As this pilot study comprised only a small number of sites, the relative rate difference pre-, during and post-intervention for each site was calculated separately and then pooled using the inverse-variance for each site as weights to obtain an estimate for the overall change in TLH uptake relative to other approaches.Statistical analyses were performed using IBM SPSS 28.0 software.

Safety outcomes
Across all timepoints and surgical approaches, 9.3% (n = 65/700) of patients experienced one or more adverse events (Table 2, and by approach in Table S3).Adverse events reported by intervention specialist trainees decreased over time, from 13.5% (n = 15/111) at pre-intervention, to 6.4% (n = 11/172) during intervention, and further decreased to 4.2% (n = 5/118) at follow-up.The proportion difference from pre-intervention to follow-up was 9.3%.Rates remained stable in the control participants (11.4%, 10.7% and 12.0% before, during and after intervention period, respectively).
The differences from pre-intervention to follow-up for 2-3 days and >4 days hospital stay were 19.9% and 6.7%, respectively.

Satisfaction with training program
Ten out of 11 participating specialist trainees completed the evaluation survey.All were confident taking what they learned and applying it to their role (Table S4).

DISCUSSION
The IMAGINE surgical training program piloted in four Australian hospitals was feasible, safe and resulted in a two-fold increased rate of TLH.Adverse events in intervention group specialist trainees decreased by 9.3% during the study in parallel with the reduction in TAH procedures, while adverse event rates remained stable in the control O&Gs.We hypothesised a drop of 20%; however adverse events were below this number at the start of the study (13.5% before the study).The structured approach to this training program allowed us to develop governance structures, administrative and technical support processes required to provide a dedicated surgical training program for practising O&Gs that could be utilised for future implementation irrespective of surgical specialty.
In this study, the proportion of hysterectomies performed via TAH by participating specialist trainees at baseline was 24%.This is similar to Australian data from 2019 to 2020, showing 26% of hysterectomies are performed annually via a TAH approach, 22 training, all hospitals showed similar decrease in TAH and increase in TLH, but post-intervention TLH rates above 70% were maintained in three of the four hospitals, while one achieved a 42% TLH rate, which was only 10% higher than its 32% baseline.
The workforce, trainer-trainee relationship, training uptake, and patient populations at each hospital may have all contributed to these differences in retention of TLH and maintaining the gains achieved after the training period.
While IMAGINE achieved a two-fold increase in TLH that was maintained during the post-intervention follow-up in most hospitals, it fell short of our stated objective of a reduction in TAH by 30% in 75% of trainees during training, and post-intervention 66% of surgical trainees continued to achieve a reduction in TAH ranging from −9% to −23%, but none achieved our goal of a greater than −30% reduction in the six months post-intervention.Possible reasons include the intervention may have been too short, and a longer-term intervention may have reduced the TAH rate further.
In this study the rate of vaginal hysterectomy (VH) decreased from pre-intervention to follow-up, due to the attention to TLH as a minimally invasive surgical alternative technique.TAH should be the last surgical option.When selecting the surgical route of hysterectomy, the preference and proficiency of the surgeon may be the most decisive factors. 23In our study, the rate of TAH decreased as did the rate of VH because this specific training program described here aimed to increase the proficiency of TLH.This pilot study could not follow all step-wedge design features according to protocol due to the limited number of hospitals and O&Gs involved, which was further compounded by the loss of two surgeon participants due to being transferred to other hospitals.Adverse events were prospectively captured.However, due to funding limitations, at some hospitals surgical and outcomes data were captured by the surgeons themselves without cross-

The
Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) training requires competence in operative endoscopic procedures (Levels 1-3), but not advanced endoscopic procedures, which include TLH (Level 5).Although O&G trainees are getting increased exposure, the training fellowships in advanced laparoscopic gynaecological surgery are limited.In addition, training fellowships target emerging specialists but do not include established, already practising O&Gs.The Implementation of Minimally Invasive Hysterectomy (IMAGINE) trial aimed to increase uptake of TLH and decrease TAH among practising Australian O&G specialists, and to pilot-test a training model building on the previous successful laparoscopic surgery colorectal (LAPCO) program.16 the surgical mentor.Stage 2 involved attending a live TLH demonstrated by the surgical mentor.The surgery was video-recorded and used to facilitate a debriefing session with intervention participating specialist trainees.Participating specialist trainees received a laparoscopic simulator training device to keep to revise surgical steps at their own discretion.Proctorship training consisted of ten training days led by the surgical mentor at the training hospital, with maximum three TLH procedures per day.The surgical mentor was the primary surgeon for the first case; the intervention specialist trainees served as assistants.The level of the mentor's involvement decreased as the specialist trainees became more proficient, until eventually the surgical mentor was present in the operating room only demonstrating specific procedural steps, supervising and demonstrating on the screen.Each participating specialist trainee's progress performed during the training was videorecorded and the surgical mentor conducted debriefing sessions.During debriefing, the surgical mentor provided feedback to the participating specialist trainees, and the specialist trainees provide feedback on the surgical mentors training, as well as sharing comments to enhance the training and goals they would like to set for the next session.The video was downloaded on an external hard drive for replaying immediately after the case for the group, but not stored otherwise.Details of each hysterectomy for the pre-, during and postintervention periods were entered into the SurgicalPerformance database either by the trainee surgeon themselves or by trained research nurses who extracted the data from the clinical files.At the end of the study, participating specialist trainees were asked to complete a survey on training program satisfaction.
ble and completed the training program.Twenty-three O&G surgeons were screened for eligibility, 11 were eligible and agreed to participate in the training; another 11 O&Gs were eligible and agreed to serve as contemporary controls, and continued with their usual surgical approach.

Of the 11
participating specialist trainees who started the intervention (three surgical trainees in Hospitals A, B and C, respectively; and two at Hospital D), 11 provided surgical outcomes data during the intervention, and 9/11 provided surgical outcomes data for the post-intervention follow-up period, while 10/11 completed the satisfaction with intervention questionnaire.Of control participants, 11 provided pre-intervention and intervention data, while 10/11 participants recorded post-intervention follow-up data (Table checking by research staff.The change in surgeon preference for one procedure or another could be due to multiple factors, the deep examination of which is outside the scope of this manuscript.In summary, we found a training and education program was demonstrated to be feasible, well-accepted and safe to accelerate the shift away from TAH toward less invasive hysterectomy approaches.AUTHOR CONTRIBUTIONSAO, GBH, MGC and MJ conceived the study; AO, MJ, NG and VG designed the study.MJ and AO screened the hospitals, implemented, and oversaw the intervention.VG, MJ, SS and CH conducted the

TABLE 2 Surgical
safety outcomes pre-, during and post-intervention in control and trainee participants

TABLE 3 Comparison
of TLH rates within each hospital site for the pre-during and during-post-intervention phases

TABLE 4
Self-reported surgical skills and preferred surgical approach reported by intervention obstetricians and gynaecologists analysis.MJ, AO, AR and CH contributed to the writing and drafting of the manuscript.All authors contributed to critical review and revision of the manuscript and approved the final version. statistical