Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Miss Marina Yiasemidou
ORCID ID
http://orcid.org/0000-0002-2599-4131
Contact details
University of Leeds
St. James University Hospital
Clinical Science Building. Level 7
Room 7.26
Beckett Street
Leeds
LS9 7TF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
165586
Study information
Scientific title
The “R-3D-2” pilot study - randomised controlled trial on the impact of surgical rehearsal strategies in rectal cancer surgery using 3d models by using 2 methods
Acronym
The “R-3D-2” pilot study
Study hypothesis
The aim of this study is to test the feasibility of recruitment of patients and surgeons who are ready to perform structured mental rehearsal using virtual and physical rehearsal aids for minimally invasive anterior resection/total mesorectal excision for rectal cancer.
Hypothesis 1: Using patient specific virtual models to mentally rehearsal a procedure will improve surgical performance and reduce patient complications after keyhole rectal cancer surgery
Hypothesis 2: Using patient specific physical (plastic) models for rehearsal procedures will improve surgical performance and reduce patient complications even further compared to mental rehearsal with virtual models only
Ethics approval
NRES Committee Yorkshire & The Humber - Leeds East, 15/03/2015, ref: 15/YH/0134
Study design
Interventional multi-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Rectal cancer
Intervention
Surgeons operating on patients randomised to group 1 will undergo Structured Mental Rehearsal (SMR) using patient specific 3D Virtual models.
Surgeons operating on patients randomised to group 2 will do the same, as well as practice on a patient specific “physical” (plastic) model.
Surgeons operating on patients randomised to group 3 will undergo Structured Mental Rehearsal using Magnetic resonance (MR) scans.
Added 20/03/2017: Surgeons operating on group 4 will undergo their routine preparation, without additional intervention.
The SMR process is based on a standardisation of the anterior resection technique, the outcome of a consensus of international experts.
Preparation of 3D virtual models: These models will be prepared through a process called 3D reconstruction. Routine MR images of patients are “uploaded” onto a 3D segmentation/reconstruction software. Through a semi-automatic process pelvic organs (rectum, mesorectum, vagina/prostate and seminal vesicles, bladder and ureters), pelvic skeleton and tumour will be “reconstructed” in a three dimensional form.
Preparation of “physical” (plastic) models: The dissection plane (mesorectal envelope) will be printed into a physical model using 3D printing technology. This will act as the mould of the outline of the dissection plane, which will be placed into a generic (non patient-specific) pelvic cavity. The surgeon will be asked to dissect this outline off the generic pelvic cavity model using laparoscopic instruments.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Surgical performance assessed by video assessment methods (Competency Assessment Tool and Objective Clinical Human Reliability Assessment (OCHRA)). Surgical performance will be assessed for each real procedure. This will be done by recording the pelvic dissection at the time of surgery through the laparoscopic camera. The recording will be sent to two experts who will rate it independently using two validated scoring systems. This process will be repeated for each procedure.
Secondary outcome measures
1. Peri-operation complications and time to complete surgery will be recorded at the time of surgery
2. Post-operative complications will be recorded after surgery until the patient is discharged from hospital. The patients will not be followed up after they leave the hospital.
3. Specimen quality (margins of dissected tissue clear/not clear of cancerous cells, number of lymph nodes retrieved). This will be recorded for each patient, once this information becomes available from our pathology laboratory.
4. Transcripts of SMR sessions. Each SMR session will be audio recorded and transcribed for qualitative analysis. This will be done throughout the data collection part of the study.
5. Semi-structured interviews. Conducting these interviews aims to explore the overall opinion of surgeons about the SMR process and the patient specific models. These will be conducted after the end of the data collection process.
Overall trial start date
22/05/2015
Overall trial end date
22/05/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients due to undergo minimally invasive surgery for rectal cancer surgery
2. They have to be older than 18 years of age
3. Both genders
4. All operations must be performed or supervised by surgeons who performed similar operations > 50 times in the past
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
63
Participant exclusion criteria
Current exclusion criteria as of 20/03/2017:
1. Patients planned for a primary Hartmann’s resection (no anastomosis planned)
2. Patients planned for abdominoperineal resection (APR)
3. Patients with anal cancer and benign lesions
4. Patients who cannot represent their interests and lack the capacity to consent for themselves
Previous exclusion criteria:
1. Patients planned for a primary Hartmann’s resection (no anastomosis planned)
2. Patients planned for abdominoperineal resection (APR)
3. Patients planned for primary open surgery, partial mesorectal excision (PME)
4. Patients planned for transrectal surgery, “bottom up” surgery
5. Patients with anal cancer and benign lesions
6. Patients who cannot represent their interests and lack the capacity to consent for themselves
Recruitment start date
22/05/2015
Recruitment end date
22/05/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James University Hospital
Leeds, West Yorkshire
-
United Kingdom
Trial participating centre
Pinderfields General Hospital
Wakefield, West Yorkshire
-
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of this study will be presented to national and international surgical conferences. The investigators also intend to publish the results in esteemed surgical journals. A summary of the results will be disseminated in outpatient colorectal clinics in the two centres where the study takes place.
Overall analysis of the results is not expected to take place later than 3 months after the completion of the study (September 2017). The investigators are hoping to publish the results of a quantitative assessment for a possible impact of the process combining SMR and patient specific models as well as a qualitative assessment of the above mentioned process and expert opinion about the same.
IPD sharing plan
Anonymised data will be kept at the University of Leeds secure server for 3 years after the completion of the study.
Intention to publish date
01/09/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary