Plain English Summary
Miss Marina Yiasemidou
University of Leeds
St. James University Hospital
Clinical Science Building. Level 7
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
The “R-3D-2” pilot study
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
NRES Committee Yorkshire & The Humber - Leeds East, ref: 15/YH/0134
Interventional multi-centre (2 centers), randomized controlled trial (RCT)
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
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.
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.
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
Overall trial end date
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
Target number of participants
Participant 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 are excluded from this study
6. Patients who cannot represent their interests and lack the capacity to consent for themselves will also be excluded
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
St. James University Hospital
Leeds, West Yorkshire
Trial participating centre
Pinderfields General Hospital
Wakefield, West Yorkshire
Leeds Teaching Hospitals Charitable Foundation (UK)
Funding Body Type
Funding Body Subtype
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.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting