Impact of minimally invasive surgery on surgeon health
| ISRCTN | ISRCTN11807724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11807724 |
| ClinicalTrials.gov (NCT) | Nil known |
| Integrated Research Application System (IRAS) | 300580 |
| Protocol serial number | 0823, IRAS 300580, CPMS 49943 |
| Sponsor | University of Leicester |
| Funder | Intuitive Surgical |
- Submission date
- 04/01/2022
- Registration date
- 04/03/2022
- Last edited
- 15/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Minimally invasive surgery (MIS) has a significantly shorter recovery and lower complication rate compared to open surgery and is the preferred route for the surgical management of many conditions. However, the impact of MIS on surgeons has been largely forgotten and many are reporting work-related musculoskeletal symptoms (WMS). The concern is that these symptoms (pain, stiffness and fatigue) have the potential to reduce the working life and productivity of surgeons. Optimising surgeons’ working conditions is vital for their own health but may also affect patient safety by affecting their surgical performance. The aim of this study is to develop and validate a multi-component assessment tool that can objectively capture the real-time physical and psychological impact performing surgery has on the surgeon.
Who can participate?
Consultant surgeons and gynaecologists at the participating hospital who are performing major abdominal surgery.
What does the study involve?
The assessment tool includes: pre/during/post procedure salivary cortisol; continuous heart rate monitoring and upper-arm/back motion sensor monitoring during the procedure; and pre/during/post procedure questionnaires. The study involves the surgeons wearing light, unobtrusive sensors that monitor motion as well as a heart monitor for the duration of the surgical procedure. Cortisol swabs will be taken before the start of the procedure, at the time of removal of the specimen, and immediately after completing the procedure. The consultants will complete questionnaires before and after the surgical procedure. Patients will be consented for their surgeon to be monitored whilst performing their surgical procedure.
What are the possible benefits and risks of participating?
Participating in the study is not associated with any further risks in addition to the risk associated with performing surgery. The equipment used to monitor the surgeon’s movements has been checked by the medical physics department to ensure that it does not interfere with equipment within the operating theatre. All the surgeons will have undergone testing and familiarization with the equipment on a simulator to demonstrate that wearing the equipment does not affect their movements.
Where is the study being conducted?
University Hospitals of Leicester (UK)
When is the study starting and how long is it expected to run for?
November 2021 to August 2024
Who is funding the study?
Intuitive Surgical (USA)
Who is the main contact?
1. Dr Esther Moss, em321@le.ac.uk
2. Dr Anumithra Amirthanayagam, aa1235@leicester.ac.uk
Contact information
Principal investigator
Leicester Cancer Research Centre
University of Leicester
Leicester
LE1 7RH
United Kingdom
 ORCID ID |
0000-0002-2650-0172 |
|---|---|
| Phone | +44 (0)116 2523170 |
| em321@le.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomized feasibility study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Impact of minimally invasive surgery on surgeon health: a feasibility study |
| Study acronym | ISSUE |
| Study objectives | The physical/psychological impact on surgeons is less with robotic-assisted surgery compared with straight-stick laparoscopy and open surgery. |
| Ethics approval(s) | Approved 06/09/2021, East Midlands - Leicester Central Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)2071048138; leicestercentral.rec@hra.nhs.uk), REC ref: 21/EM/0174 |
| Health condition(s) or problem(s) studied | Surgeons performing live surgical procedures (open/laparoscopic/robotic). |
| Intervention | This study aims to develop and validate a 5-point assessment tool to objectively measure both the physical and psychological impact of complex surgical cases on a surgeon, in order to give a single categorisation of impact: high, intermediate or low. Data will be collected from surgeons performing live surgical procedures: continuous heart rate monitoring; salivary cortisol; continuous movement sensor monitoring; State Trait Anxiety Inventory questionnaire; and musculoskeletal symptoms questionnaire. Patients will be consented for their surgeon to undergo monitoring during their surgical procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The proportion of surgical procedures where all five variables of the assessment tool are captured (continuous heart rate [HR] monitoring; salivary cortisol (taken pre-, intra- and post-operatively); continuous movement sensor monitoring; State-Trait Anxiety Inventory (STAI) questionnaire and modified Nordic work-related musculoskeletal symptoms (WMS) questionnaire), taken pre- and post-operatively |
| Key secondary outcome measure(s) |
1. A single value of ‘impact’ (high/intermediate/low) per procedure calculated by combining the five recorded variables will be calculated on completion of participant recruitment to the feasibility cohort |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 165 |
| Key inclusion criteria | Surgeons: 1. Consultant Surgeons and Gynaecologists 2. Able to consent 3. Patient consents to their surgeon participating in the study Patients: 1. All patients 2. Able to consent 3. Undergoing intra-abdominal surgery with a procedure expected to last less than 2 hours in duration 4. Aged >18 years |
| Key exclusion criteria | Patients who do not consent for their surgeon to participate |
| Date of first enrolment | 10/01/2022 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as there is patient data as well as personal information relevant to the participants, including their anthropometry, and this will be stored safely in an anonymised manner on the research drive of the University of Leicester. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 5 | 24/09/2022 | 05/04/2024 | No | No |
Additional files
- ISRCTN11807724 ISSUE Protocol V5 24Sep22.pdf
- Protocol file
Editorial Notes
15/10/2024: The following changes were made:
1. The recruitment end date was changed from 10/02/2023 to 31/08/2024.
05/04/2024: The following changes were made to the trial record:
1. The overall end date was changed from 29/11/2023 to 31/08/2024.
2. The intention to publish date was changed from 01/04/2024 to 01/08/2025.
3. The plain English summary was updated to reflect these changes.
4. Uploaded protocol (not peer-reviewed) as an additional file.
01/04/2022: Internal review.
21/02/2022: Trial's existence confirmed by the HRA.
