Image: The IAP system provides a surgical support platform to aid retraction in laparoscopic surgery (Photo courtesy of University of Leeds)
Surgical technology is often developed for well-resourced healthcare systems – and is of little or no use in poorer settings where hospitals lack sophisticated support infrastructure or appropriately trained staff. Without access to medical equipment they can use, hospitals and clinics in low-to-middle income countries cannot offer surgical treatment to nine out of 10 patients. Thus, medical equipment that can be manufactured at low cost, is simple to use and can be easily maintained will help extend surgery to the five billion people worldwide who currently cannot get access to it. An international research team has now designed a simplified surgical tool for performing laparoscopic – or keyhole surgery – in low resource settings. The result is that laparoscopic surgery can now be carried out in clinics and hospitals where it was not possible before.
The surgical tool was created by a research team led by the University of Leeds (West Yorkshire, UK) with a focus on creating medical devices specifically for use in low-to-middle income countries. The team has pioneered a development approach based on “participatory design”, where the users of the technology are closely involved in its design – and where functionality of the device is pared back to key essentials. The simplified design of the surgical tool meant it was easier for the device manufacturer to get regulatory approval, with the time it takes to go from design to approval being four years in this case, as compared to 10 years generally. The surgical tool also meets the guidelines established by the World Health Organization for the design and development of healthcare technology for low to middle income countries. It says they should follow four key principles, the 4As – affordability, accessibility, availability and appropriateness.
During laparoscopic operations, the surgeon inflates the patient’s abdomen with CO2 gas, to create space to see internal organs and to manipulate instruments. That comes with two challenges. It requires operating theaters to have a reliable CO2 gas supply. It also requires the patient’s abdominal muscles to be fully relaxed requiring a general anesthetic and an anesthetist to give it. An alternative approach called gasless laparoscopy has been developed. Rather than pumping CO2 into the abdomen, a mechanical retractor or clamp is used to lift the abdominal wall. With this method, the patient does not need a general anesthetic – instead, a spinal anesthesia is given, and there is no need for a dedicated anesthetist to be present. But this alternative approach has failed to gain popularity, largely because of challenges with using and maintaining the retractors.
The researchers, in partnership with surgeons and a medical device manufacturer, designed a new retractor, ensuring it was fit for purpose in a low-resourced healthcare setting. A small ring is manipulated onto the end of the retractor by a surgeon using keyhole techniques. When in place, the device is manually operated to gently lift the abdominal cavity upwards, creating the necessary space for the surgical team to operate. Known as RAIS (Retractor for Abdominal Insufflation-less Surgery), the innovative retractor went through five design iterations before a prototype was developed and tested. During a clinical evaluation, it was used in 12 laparoscopic operations: in four cases of appendicitis, two hysterectomies and six cases where the gall bladder was removed. There were no adverse events from using the retractor.
“Laparoscopic surgery has benefits for patients. People recover more quickly, and the risks of cross infection are lower,” said Dr. Pete Culmer, Associate Professor in Healthcare Technologies at Leeds, who supervised the research. “But in many parts of the world, laparoscopic techniques are not widely used because of the need to use equipment that cannot be easily maintained or relies on complex infrastructure in the operating theatre.
“We partnered with clinicians in India to work on developing instruments that would make the process simpler, with the aim of enabling laparoscopic surgery to be available in more locations around the world,” added Dr. culmer.
“The biggest problem for rural surgeons needing to provide laparoscopic surgery is finding an anesthesiologist and the equipment to give general anesthesia,” said Dr. Jesudian Gnanaraj, a surgeon who has pioneered gasless laparoscopic surgery and worked extensively in parts of rural India where surgery has not typically been available. “The RAIS device makes laparoscopic surgery possible, with lower costs and easily available resources like spinal anesthesia.”
University of Leeds