Condition category
Cancer
Date applied
14/06/2015
Date assigned
12/07/2015
Last edited
07/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, ref: 15/YH/0134

Study design

Interventional multi-centre (2 centers), randomized controlled trial (RCT)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

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.

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

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

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

Sponsor information

Organisation

University of Leeds

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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