The “R-3D-2” pilot study - the impact of rehearsal strategies prior rectal cancer surgery, using patient individualised 3D models

ISRCTN	ISRCTN75603704
DOI	https://doi.org/10.1186/ISRCTN75603704
Secondary identifying numbers	165586

Submission date: 14/06/2015
Registration date: 12/07/2015
Last edited: 21/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-improve-surgery-for-rectal-cancer-r-3d-2-study

Contact information

Miss Marina Yiasemidou
Public

University of Leeds
St. James University Hospital
Clinical Science Building. Level 7, Room 7.26
Beckett Street
Leeds
LS9 7TF
United Kingdom

ORCID ID	0000-0002-2599-4131

Study information

Study design	Interventional multi-centre randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	The “R-3D-2” pilot study
Study objectives	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(s)	NRES Committee Yorkshire & The Humber - Leeds East, 15/03/2015, ref: 15/YH/0134
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	22/05/2015
Completion date	22/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	63
Key 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
Key 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
Date of first enrolment	22/05/2015
Date of final enrolment	22/05/2017

Locations

Countries of recruitment

United Kingdom

Study participating centres

St James University Hospital

Leeds, West Yorkshire
-
United Kingdom

Pinderfields General Hospital

Wakefield, West Yorkshire
-
United Kingdom

Sponsor information

University of Leeds
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals Charitable Foundation (UK)

No information available

Results and Publications

Intention to publish date	01/09/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

07/06/2016: Cancer help UK lay summary link added.