Rectal cancer Cancer
Conditions
Interventions
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
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Contacts
Public ContactMarina Yiasemidou
Outcome results
None listed