Comparing international data between keyhole and robotic rectal cancer surgery
| ISRCTN | ISRCTN75281193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75281193 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 319973 |
| Protocol serial number | CPMS 56922, IRAS 319973 |
| Sponsor | Portsmouth Hospitals NHS Trust |
| Funder | Intuitive Foundation |
- Submission date
- 26/10/2023
- Registration date
- 12/12/2023
- Last edited
- 14/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is an investigation into the medical outcomes of patients with rectal cancer who underwent a surgical procedure called "Total Mesorectal Excision" (TME) with the assistance of robotic technology. Instead of studying patients in real-time, we're taking a look back in time to analyse data from multiple medical centers where this robotic surgical technique was used.
The primary goal of our research is to determine whether the use of robots in TME surgery has a positive impact on the long-term health and recovery of patients with rectal cancer. We aim to collect and analyse data, comparing the outcomes of patients who had robot-assisted TME surgery with those who underwent traditional procedures.
Who can participate?
Patients aged 18 years or older who underwent rectal cancer surgery beginning in 2014.
What does the study involve?
We aim to combine retrospective data from 3 European datasets (for an estimated total of 3,000 inclusions) to perform high-quality statistical analyses on surgical outcomes (such as length of stay, operative time, and conversion) between laparoscopic and robotic proctectomy with partial or complete TME surgery. We will only be collecting data on patients treated after 2014 in all centres. The study will also have secondary objectives, such as complications, reinterventions and readmissions, pathological outcomes, stoma formation and reversal, and short- and long-term oncological outcomes (local recurrence, distant recurrence, disease-free survival, and overall survival).
What are the possible benefits and risks of participating?
None
Where is the study run from?
Portsmouth Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2023 to June 2025
Who is funding the study?
Intuitive Foundation (USA)
Who is the main contact?
Rauand.Duhoky@porthosp.nhs.uk
Contact information
Public, Scientific, Principal investigator
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
 ORCID ID |
0000-0003-3118-0641 |
|---|---|
| Phone | +44 (0)2392286000 ext 3529 |
| Rauand.Duhoky@porthosp.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Retrospective, Propensity Score Matched Analysis of Short- and Long-term Outcomes in Laparoscopic versus Robotic Total Mesorectal Excision: an international, multi-centre data study |
| Study acronym | RESOLUTION |
| Study objectives | Current study hypothesis as of 05/02/2025: This study is a retrospective, multi-centre data study analysing the oncological outcomes in rectal cancer patients that underwent robotic "Total Mesorectal Excision" (TME) surgery. We aim to combine retrospective data from 3 European datasets (for an estimated total of 3,000 inclusions) to perform high quality statistical analyses on surgical outcomes (such as length of stay, operative time, and conversion) between laparoscopic and robotic proctectomy. _____ Previous study hypothesis: This study is a retrospective, multi-centre data study analysing the oncological outcomes in rectal cancer patients that underwent robotic "Total Mesorectal Excision" (TME) surgery. We aim to combine retrospective data from 3 European datasets (for an estimated total of 3,000 inclusions) to perform high quality statistical analyses on surgical outcomes (such as length of stay, operative time, and conversion) between laparoscopic and robotic proctectomy with partial or complete TME surgery. |
| Ethics approval(s) |
Approved 12/06/2023, HRA and Health and Care Research Wales (HCRW) (5-15, Castlebridge, 19 Cowbridge Rd E, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 230457; healthandcareresearch@wales.nhs.uk), ref: 23/HRA/2175 |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | Current interventions as of 05/02/2025: This is a multicentre, retrospective cohort study for comparative analysis of postoperative surgical outcomes and short- and long-term oncological outcomes after rectal cancer surgery using propensity score-matched cohorts. The study is looking to include all eligible patients treated after 2014 whose data is available at one of the three participating sites and estimates an inclusion of 3000 patients in total. All data transfer will comply with local and UK privacy laws, and have been outlined in a "Data Sharing Agreement" and "Data Management Plan". After reception at the Sponsor site, data will be checked for errors and converted to a file suitable for statistical analysis. This process has been outlined in detail in the "Data Management Plan" as well. This study will not have any influence on the care or lives of patients included in the study. There is no direct benefit and no additional risk for included patients. A patient is eligible for inclusion when they meet all the inclusion criteria and none of the exclusion criteria for the study, as outlined in the protocol. _____ Previous interventions: This is a multicentre, retrospective cohort study for comparative analysis of postoperative surgical outcomes and short- and long-term oncological outcomes after rectal cancer surgery using propensity score-matched cohorts. The study is looking to include all eligible patients treated after 2015 whose data is available at one of the three participating sites and estimates an inclusion of 3000 patients in total. All data transfer will comply with local and UK privacy laws, and have been outlined in a "Data Sharing Agreement" and "Data Management Plan". After reception at the Sponsor site, data will be checked for errors and converted to a file suitable for statistical analysis. This process has been outlined in detail in the "Data Management Plan" as well. This study will not have any influence on the care or lives of patients included in the study. There is no direct benefit and no additional risk for included patients. A patient is eligible for inclusion when they meet all the inclusion criteria and none of the exclusion criteria for the study, as outlined in the protocol. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The primary outcome variables will be measured using data held in pre-existing databases at each of the participating sites from rectal cancer patients who underwent robotic total mesorectal excision (TME) surgery at one timepoint: |
| Key secondary outcome measure(s) |
The secondary outcome variables will be measured using data held in pre-existing databases at each of the participating sites from rectal cancer patients who underwent robotic total mesorectal excision (TME) surgery at one timepoint: |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 3000 |
| Key inclusion criteria | Current inclusion criteria as of 05/02/2025: 1. All patients who underwent a laparoscopic or robotic proctectomy since 2014; 2. Aged 18 years or above; 3. Rectal cancer tumour located within 15 cm from the anal verge or 20 cm from the anorectal junction. _____ Previous inclusion criteria: 1. All patients who underwent a laparoscopic or robotic proctectomy with partial or complete TME after 2015; 2. Aged 18 years or above; 3. Rectal cancer tumour located within 15 cm from the anal verge or 20 cm from the anorectal junction. |
| Key exclusion criteria | Current exclusion criteria as of 05/02/2025: 1. Patients that underwent robotic TME surgery as part of a more complex procedure, for example a peritonectomy, or a synchronous colonic or hepatic resection. 2. Patients that underwent palliative resection 3. Patients that underwent emergency resection _____ Previous exclusion criteria: 1. Patients that underwent an APER or Hartmann’s procedure 2. Patients that underwent robotic TME surgery as part of a more complex procedure, for example a peritonectomy, or a synchronous colonic or hepatic resection. 3. Patients that underwent palliative resection 4. Patients that underwent emergency resection |
| Date of first enrolment | 04/07/2023 |
| Date of final enrolment | 01/02/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- France
- Netherlands
Study participating centres
Cosham
Portsmouth
PO6 3LY
United Kingdom
-
France
-
Netherlands
-
France
-
France
-
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/04/2025 | 14/04/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/04/2025: Publication reference added.
05/02/2025: The following changes were made to the trial record:
1. The study hypothesis was changed.
2. The overall end date was changed from 01/02/2025 to 01/06/2025.
3. The interventions were changed.
4. The inclusion criteria were changed.
5. The participant level data sharing statement was added.
14/06/2024: The following changes were made:
1. The recruitment end date was changed from 01/06/2024 to 01/02/2025.
2. The overall study end date was changed from 01/06/2024 to 01/02/2025.
26/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
