Real-world evaluation of robot-assisted surgical services

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18320267

Enrollment

2650

Registered

2022-10-10

Start date

2022-07-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of robot-assisted surgery Surgery

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: All patients undergoing the index procedure (robot-assisted surgery or otherwise) at each site across all time periods

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom, Wales

Contacts

Public ContactSITU-NDORMS Team

REINFORCE@ndorms.ox.ac.uk+44 (0)7721 491938

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026