Robotic Colorectal Surgery minimum standard guidance

This guidance is aimed at establishing a high standard for the use and maintenance of robotic surgery in colorectal practice. The aim of this guidance is twofold, firstly to ensure that the necessary standard is maintained by the respective hospital/theatre complex for the safe use of a surgical robot, and that the surgical team is of the required standard to utilize the technology in the best possible way for good patient outcomes. The utilization of a robotic platform for a procedure must be evidence based.

Background:

Surgical robotic systems (master-slave systems) were developed to augment the surgeon’s senses, dexterity and precision. Robotic systems therefore have the potential to augment surgical outcomes by precision surgery, where there is an indication for the technology and the surgeon has the technical skills. To maximize this potential, the practitioner should be sufficiently well versed in the procedure that they are performing so that the robotic platform can maximize outcomes, without sacrificing any performance due to lack of technical experience or insight.

There are thus certain minimum requirements that should be adhered to in order to justify both the initial training of a surgeon, and then their continued certification.

Surgeon Requirements:

  • The surgeon should be proficient in minimally invasive pelvic dissection for colorectal pathology with outcomes in keeping with International Standards. Proficiency measured in outcomes should be the gold standard. Until such a time when robust outcomes data is available, the best measure of proficiency is surgeon volumes. The Societies are aware of the limitations of using volumes as surrogate , but with robust data supporting improved outcomes in high volume centres, minimum requirements should be calculated on surgeon volume, until outcomes data is available.
  • Any surgeon who is enrolled for robotic training should have outcomes data available, or a minimum volume of at least 15 pelvic dissections done with so called “minimum invasive techniques” per annum. These may include:
  • Total Mesorectal Excision o Partial Mesorectal Excision o Anterior resection of the rectum o Abdomino-perineal Resection o Ventral Mesh Rectopexy o Proctectomy with or without ileoanal pouch.
  • Outcomes and or volumes should be consistent, and not be below minimum standards assessed over a three-year period. Only surgeons who can prove outcomes or volume should be considered candidates for robotic training and robotic practice.
  • Robotic Training must involve technical training in the use of the technology. This must include hands on and theoretical modules to familiarize the surgeon and their team with the technology, software and hardware and safe use of the robotic system.
  • Robotic training must involve hands on training of the surgeon in the safe use of the platform and must be done at a training facility, accredited by the Robotic Company.
  • Final accreditation upon completing above training is for a robotic company proctor to observe the surgeon in their own theatre, using their own robotic system performing colorectal procedures. The format of the initial learning curve and final sign off by the proctor may vary from one prospective surgeon to another and is at the discretion of the accredited robotic proctor. The proctor and/or company training pathway should be endorsed and recognized by the South African Colorectal Society. The final accreditation will lie on this proctor to award.
  • Once fully accredited it falls to the robotic colorectal surgeon to maintain the required standards to keep up the robotic system technical knowledge and the procedure technique that will allow for best possible outcomes for the patient.
  • Without proof of outcomes data, the minimum number of robot surgeries that the surgeon should be involved in per annum:
    • 10 procedures as primary surgeon
    • Or 15 procedures as either the primary surgeon, or as an assistant.
  • All robotic cases should be entered in a Society accredited robotic database (either South African Colorectal Society accredited robotics database, or ERAS database.) The data entered must include outcomes.
    • This data will be handled in line with all POPI act requirements and is for research purposes.

System Requirements:

  • The surgical robot must be in fully operational state with no technical errors, with any internet link always connected (this may vary from system to system).
  • All consumables, including anticipated instruments, and instruments that may be needed in an unexpected surgical event must be available within the robotic theatre complex.

Theatre Requirements:

  • The Surgical Robot is not to be used if the theatre complex UPS system is faulty.
  • A full theatre team, with a trained robotic scrub sister must be present. If no surgical scrub sister is available, the case may not go ahead.
  • The scrub sister may not assist with the surgical case, and may only assist with the preparation, care and docking/undocking of the robot and robotic instruments (as per nursing council rules).
  • A robotic trained assistant with knowledge of the robotic surgical system, its instrumentation and the planned procedure must be present.

Non-compliance:

Should the above not be adhered to, the surgeon will not be considered to have maintained the high level expected of practitioners doing this highly technical surgery with advanced technology and as such will lose their Colorectal Society robotic accreditation. To regain accreditation, the surgeon will have to redo the full, or part of the robotic proctorship and demonstrate that they have the necessary volume to continue a robotics practice.

Peer review:

Peer review is the responsibility of the South African Colorectal Society (SACRS) with or without the assistance of the Association of Surgeons of South Africa (ASSA) and/or The South African Society of Endoscopic Surgeons (SASES). Adherence to minimum standards is the responsibility of the individual surgeon and hospital. Queries by hospitals, surgeons or funders should be addressed to SASES.