Real-world evaluation of robot-assisted surgical services
| ISRCTN | ISRCTN18320267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18320267 |
| IRAS number | 311223 |
| Secondary identifying numbers | CPMS 53026, IRAS 311223 |
- Submission date
- 07/07/2022
- Registration date
- 10/10/2022
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
This study aims to work out if robot-assisted surgery (RAS), a relatively new development, should be routinely available in the NHS and also assess any barriers to its implementation. Over the next 20 years, surgery performed with the help of a robot is expected to increase rapidly around the world, especially for cancer conditions. Previous research shows that when RAS has been introduced in some clinical areas, like urology, it can help surgeons be more precise and can reduce a patient’s hospital stay. Using RAS may also speed up training for surgeons to enable them to become experts more quickly. However, RAS has not been tested in all clinical areas and is very expensive with each robot costing over £ 1 million). Also, when RAS is introduced into hospitals it requires special consideration as the set-up can be disruptive. It is not yet clear whether the benefits to patients or the health system of doing surgery this way is worth the cost and the disruption. This study aims to answer that question and provide guidelines for the best way of doing it if robotic surgery is shown to be useful.
We have designed the research to be able to measure the impact of RAS as it is introduced in the UK and scaled up in other hospitals currently performing robotic surgery but planning to expand services. It will study the effects of RAS as it is rolled out at 16 different sites in a planned way. We will measure what happens to patients who get RAS as part of the service and compare their outcomes (e.g., complications, recovery time) to conventional surgery. We will also track how introducing RAS impacts on the staff and the surgeons, and how it affects wider care in hospitals across the country.
This study aims to undertake a real-world, large-scale evaluation of the introduction and scale-up of RAS services evaluating its impact on NHS service delivery, clinical effectiveness, budget and cost-effectiveness.
Who can participate?
Any patient undergoing the specified surgical procedure at a participating hospital site
What does the study involve?
The study involves patients completing a questionnaire before and after surgery to evaluate their experience of the procedure. We will also interview and survey staff involved with REINFORCE at sites, and calculate the total cost to the NHS (e.g., labour, consumables and other items of surgical equipment).
What are the possible benefits and risks of participating?
There is no direct benefit to participants, but the results of the study are likely to benefit future NHS patients undergoing surgery. Outside of the usual risks associated with surgery and anaesthetic, there are no anticipated risks or disadvantages to participating in the REINFORCE study.
Where is the study run from?
Surgical Intervention Trials Unit (SITU), University of Oxford and Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen (United Kingdom)
When is the study starting and how long is it expected to run for?
January 2022 to June 2025
Who is funding the study?
NIHR Health and Social Care Delivery Research (NIHR HSDR) (United Kingdom)
Who is the main contact?
REINFORCE@ndorms.ox.ac.uk
Contact information
Public
NDORMS
University of Oxford
Nuffield Orthopaedic Centre
Oxford
OX3 7HE
United Kingdom
 ORCID ID |
0000-0002-5848-5333 |
|---|---|
| Phone | +44 (0)7721 491938 |
| REINFORCE@ndorms.ox.ac.uk |
Principal Investigator
NDORMS
University of Oxford
Nuffield Orthopaedic Centre
Oxford
OX3 7HE
United Kingdom
| ORCID ID |
0000-0001-7884-6389 |
|---|---|
| Phone | +44 (0)1865 227695 |
| David.Beard@ndorms.ox.ac.uk |
Principal Investigator
Health Services Research Unit
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| ORCID ID |
0000-0001-5386-4097 |
|---|---|
| Phone | +44 (0)1224 273161 |
| m.k.campbell@abdn.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A real-world, in-situ, evaluation of the introduction and scale-up of robot-assisted surgical services in the NHS: Evaluating its impact on clinical and service delivery, effectiveness and cost (the REINFORCE study) |
| Study acronym | REINFORCE |
| Study hypothesis | This study aims to undertake a real-world, large-scale evaluation of the introduction and scale-up of Robot-Assisted Surgery (RAS) services evaluating its impact on NHS service delivery, clinical effectiveness, budget and cost-effectiveness. |
| Ethics approval(s) | This is an observational study of healthcare professionals. The Sponsor, University of Oxford, reviewed the study as a Service Evaluation project and indicated the project does not need to be submitted for REC review. |
| Condition | Evaluation of robot-assisted surgery |
| Intervention | 1. Study design: A stepped-wedge evaluation with integrated process evaluation and economic assessment. 2. Study sites: NHS hospitals planning to introduce/expand robot-assisted surgery (RAS) services. Sites will be switched over from non-RAS to RAS-augmented services (or switch up from one level of provision to another) in random order 3. Study participants (stepped-wedge evaluation): All patients undergoing the index procedure (RAS or otherwise) at each site across all time periods of the study The project is embedded in normal NHS care and it is intended to be non-selective (all patients undergoing surgery for the index procedure are candidates). 4. Participants (process evaluation): Three key personnel including surgeons, theatre staff and service managers will be sampled from 6 REINFORCE sites and invited to interview. Additionally, 3-4 commissioners will also be interviewed and sampled from across the suite of trial sites. The sample size overall will be approximately 40 interviews. Sample Size: 2,560 procedures 5. Objectives: 5.1. Impact of RAS system transformation on clinical and service delivery 5.2. Budget impact and cost-effectiveness to the NHS of the introduction of RAS at scale 5.3. Potential benefits and harms of RAS across and within speciality areas 5.4. Mechanisms of change underpinning any change in outcome, including surgeon training |
| Intervention type | Other |
| Primary outcome measure | 1. Patient level: 1.1. Disease-specific quality of life measured using procedure-specific PROM at baseline and 3 months 1.2. Overall quality of life measured using the EQ-5D questionnaire at baseline and 3 months 1.3. Overall measure of treatment effectiveness/benefit measured using a Patient Questionnaire at baseline and 3 months 1.4. Overall measure of complications inc. mortality measured using Clavien-Dindo score at 3 months 2. Surgeon/Team level: 2.1. Precision/accuracy measured using Surgeon Task Load Index (TLX) on the day of surgery 2.2. Visualisation measured using Surgeon Task Load Index (TLX) on the day of surgery 3. Organisation level: 3.1. Equipment failure measured using a Surgery Form on the day of surgery 3.2. Standardisation of operative quality measured using process evaluation interviews pre/peri/post-robot-assisted surgery (RAS) implementation 3.3. Overall economic/cost-effectiveness measured using Health Economics review throughout the study 4. Population level: 4.1 Equity of access measured using Health Economics review throughout the study |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2022 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2560; UK Sample Size: 2560 |
| Participant inclusion criteria | All patients undergoing the index procedure (robot-assisted surgery or otherwise) at each site across all time periods |
| Participant exclusion criteria | Does not meet the inclusion criteria |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Dept of Urology
Cardiff & Vale University Health Board
Heath Park
Cardiff
CF144XW
United Kingdom
Dept of Gastroenterology
Cardiff & Vale University Health Board, University Hospital of Wales
Heath Park
Cardiff
CF144XW
United Kingdom
Dept of Gynaecology
Penrhosgarnedd
Bangor
Gwynedd
LL57 2PW
United Kingdom
Dept of Gynaecological Oncology
Cardiff & Vale University Health Board
Heath Park
Cardiff
CF144XW
United Kingdom
Sponsor information
University/education
University Offices
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270000 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Surgical Intervention Trials Unit (SITU) at situ@ndorms.ox.ac.uk. Further details will be made available at a later date. |
Editorial Notes
27/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2024 to 31/03/2025.
2. The overall end date was changed from 30/04/2025 to 30/06/2025.
3. The plain English summary was updated to reflect these changes.
01/12/2022: Internal review.
07/11/2022: Internal review.
01/11/2022: Internal review.
07/07/2022: Trial's existence confirmed by the NIHR.
