None listed
Conditions
Brief summary
This study is testing whether a surgical robot called the Toumai® MT-1000 can be used to perform bowel (colorectal) and abdominal wall surgery safely and effectively at Concord Repatriation General Hospital, where it has been newly introduced. Who is it for? You may be eligible for this study if you are an adult patient undergoing an elective colorectal or abdominal wall reconstructive procedure, including patients who have been diagnosed with cancer and are suitable for minimally-invasive surgery. Study details Participants will have their operation performed using the robot by experienced, specially credentialled robotic surgeons, with the operation itself unchanged from what they would normally have. Participants complete short quality-of-life questionnaires before surgery and at 6 weeks, 3 months and 6 months afterwards, while the research team collects routine information about the operation and recovery from the medical record. The two main things being measured are how often the robotic operation needs to be converted to open surgery (a measure of feasibility) and how often serious complications occur (a measure of safety), with results for bowel cancer patients compared against similar past patients who had standard keyhole (laparoscopic) surgery. It is hoped that findings from this study will help inform clinicians and researchers whether the Toumai® MT-1000 is a feasible and safe system for such operations.
Interventions
Participants undergo their planned, clinically-indicated colorectal or abdominal wall reconstructive procedure performed using the Toumai® MT-1000 robotic surgical system (MicroPort MedBot; ARTG ID 487874), on loan to Concord Repatriation General Hospital for 12 months.
How the system is used: The Toumai® MT-1000 is a master–slave robotic surgical system comprising a surgeon console, a patient-side cart with multiple interactive robotic arms holding interchangeable EndoWrist-style articulating
Participants undergo their planned, clinically-indicated colorectal or abdominal wall reconstructive procedure performed using the Toumai® MT-1000 robotic surgical system (MicroPort MedBot; ARTG ID 487874), on loan to Concord Repatriation General Hospital for 12 months. How the system is used: The Toumai® MT-1000 is a master–slave robotic surgical system comprising a surgeon console, a patient-side cart with multiple interactive robotic arms holding interchangeable EndoWrist-style articulating instruments, and a 3D high-definition endoscope. After the patient is positioned and anaesthetised, pneumoperitoneum is established and laparoscopic ports are placed; the patient-side cart is docked and the robotic arms connected to the ports. The operating surgeon controls the instruments and camera remotely from the console while a bedside assistant exchanges instruments and provides retraction. Dissection, vessel division, bowel resection, anastomosis and/or hernia repair are performed robotically; the cart is then undocked for specimen retrieval and closure. Eligible procedures (each performed as a single robotic operative episode): right/extended right, left and sigmoid colectomy; anterior and low anterior resection; subtotal colectomy; total proctocolectomy; abdominoperineal resection; total mesorectal excision with or without lateral pelvic lymph node dissection; reversal of Hartmann's; ventral rectopexy; robotic trans-anal minimally invasive surgery (TAMIS); and ventral/incisional/parastomal hernia repair with or without transversus abdominis release / component separation (including extended totally extraperitoneal [eTEP] repair). Approximate duration: each procedure is a single operative episode of approximately [[surgery duration — e.g. "2 to 6 hours depending on procedure complexity"]]. Procedures are delivered by surgeons who are credentialled da Vinci Xi users and who complete Toumai-specific training plus a minimum of five proctored cases — assessed using the Global Evaluative Assessment of Robotic Skills (GEARS) tool — before operating independently. Surgical indications, technique and peri-operative care are otherwise unchanged from standard practice. Adherence monitoring: Adherence to the intervention is monitored via a peri-operative data collection form completed in REDCap at the conclusion of each procedure, the standard operation report in the medical record, and review of GEARS assessments during the proctored phase. Participants are followed for 6 months. Target enrolment is 30 participants (25 colorectal, 5 abdominal wall).
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient participants: adults aged 18 years or older; undergoing an elective colorectal or abdominal wall reconstructive procedure; clinically suitable for a robotic approach; able to provide written informed consent. All genders eligible; both public and private patients eligible regardless of Medicare or insurance status. Health-professional participants (experience survey): any clinician — including surgeons, anaesthetists and theatre nurses — present in theatre for a Toumai® MT-1000 procedure during the trial.
Exclusion criteria
1. Cannot consent — the patient is unable to provide written informed consent for themselves. 2. Unsuitable for robotic-assisted surgery on clinical assessment, defined as one or more of: a. haemodynamic instability precluding prolonged pneumoperitoneum; b. prior major abdominal surgery with extensive adhesions judged likely to prevent safe robotic access; c. body habitus or anatomical factors incompatible with safe robotic positioning; d. emergency or urgent surgical presentation.
Outcome results
None listed