A team across two continents to open up keyhole surgery

Gasless laparoscopic surgery, pioneered in India to provide an alternative way of lifting the patients abdomen to carry out surgery to rural areas without the need for gas.  The current equipment used is cumbersome, difficult to maintain and hard to sterilised.  A collaborative research team of surgeons, engineers and designers from the UK and India have come together to design a new gasless laparoscopy lift device which is easier to use, lighter and easier to maintain.

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Project GILLS – India

In 2017, the NIHR Global Health Research Group – Surgical Technologies partnered with a group of Indian surgeons involved in an initiative to train rural surgeons of North-East India in laparoscopic surgery. The geography, subtropical climate and limited infrastructure of the region made access to surgery challenging. The research focus of the group was broadly based around the six indicators as per the Lancet Commission on Global Surgery.

 

 

 

 

 

 

The India team identified key rural surgeons from four states of North-East India who had expressed an interest in gasless laparoscopic surgery. In March 2019, the project launched a three-day structured training programme, the TARGET study, in a tertiary hospital in Kolkata, India, to train and evaluate laparoscopic skills. The study consisted of didactic training and assessment of knowledge and skill acquisition. The group used validated scoring tools (MISTELS) to assess laparoscopic skills on standard and low-cost box simulators. Surgical and laparoscopic skills were assessed using OSATS and GOALS scoring systems, respectively.  The training and assessment were delivered by the Indian faculty. The trainees received one-to-one training during the course. The TARGET study led to the establishment of the GILLS Regional training centre for rural surgeons at Kolkata Medical College and Hospital. The results showed a steady progression of laparoscopic skills pre and post training.  The programme also gave a good exposure of the GILLS technique. Two months later, the training programme continued with proctorship for rural surgeons in their hospital facility in North-East India by the trainers who had participated in the initial TARGET study.

The Gills Registry was developed to gather clinical outcomes data. The data which is currently being analysed will provide valuable information around safety, decision-making, and cost-effectiveness.

The NIHR GHRG project has catalysed a growing community of surgeons who are interested in introducing gasless laparoscopic surgery in rural settings of India. In addition, several centres in Africa have also expressed an interest in gasless laparoscopy training.

The collaborators in India are in the process of finalising the curriculum for training in gasless laparoscopy and will seek national accreditation and validation of the training programme. The Registry will move from a regional to a national level, capturing evidence on outcomes on patients undergoing GILLS procedure in a rural setting. A final assessment of the TARGET training programme is planned to take place in the near future. All these initiatives will be led and managed by team India.

A major highlight was to attend the annual conference of the Association of Rural Surgeons of India. We meet a large community of rural surgeons and got a chance to learn about essential topics in rural surgery and establish networks for future collaboration. During the conference our group was able to deliver training sessions and research seminars to share innovation ideas. Curries made from locally grown products and the Indian cultural programme was an added bonus . The group will cherish countless memories of this wonderful experience.

In conclusion, the overall results of the project have been a massive success in establishing a sustainable training programme in gasless laparoscopy and it is hoped that the impact will be far reaching.


GHRG-ST in Sierra Leone

The VITAL Trial was conducted in November 2019, where 30 surgical trainees from Connaught Hospital and the CapaCare Surgical Training Programme took part in a lower-limb amputation training course. Here the research group explored the feasibility and acceptability of a virtual reality (VR) training platform for use on trainee’s own mobile phones. The results were promising and demonstrate the feasibility of the technology even in challenging contexts. Click here to hear the perspectives of the first users.

 

 

 

 

 

 

 

 

 

 

The next steps are to develop new training modules covering different operations and to scale up the platform so we can do larger studies and hopefully benefit more trainees globally.

The FIXT Trial is ongoing with continuation of patients receiving the Ilizarov circular frames. Some of the first frame patients have had their fixator removed and are continuing to make a good recovery. Formal analysis and results cannot be presented at this time. We would like to thank our colleagues at Connaught Hospital for their continued efforts on this study, and we hope they stay safe in this challenging time.


Emerging findings from health systems field research’

Over the past three years we have worked with the Kohima Institute in Nagaland (kohimainstitute.org), North East India and the College of Medicine and Allied Health Sciences in Freetown (usl.edu.sl/comahs), Sierra Leone to understand what prevents people accessing surgical services. Teams in both countries have undertaken interviews with patients, traditional providers, hospital staff and policy makers to understand factors that lead to the low rates of essential surgery we see in both contexts.

There is no doubt that health facilities in both contexts frequently lack the essential equipment and supplies to undertake safe surgery. Surgeons in Sierra Leone talk of ‘carpenters without tools’ referencing a lack of capability to undertaken diagnostics. A lack of resource means that patients must often bring their own medicines and supplies. Staff consequently have a hard job in ensuring these items are in-date and remain effective. In North East India, the availability of anaesthetics and stocks of blood often hinder the ability to provide safe surgical care.

Yet it is factors that are beyond the basic availability of services that often present the greatest obstacles preventing people accessing surgery.  In North East India, for example, the terrain is often challenging with poor roads that get worse during the rainy seasons inhibiting access to services. Rates of essential surgery fall dramatically for communities that are distant from a hospital.

How to pay for care is often a major concern for families making the decision where to take loved one for treatment. The non-government sector in North East India is much more physically accessible yet the cost of an essential operation such as caesarean section can represent more than 3 months average income. Against this background, traditional providers often seem a more viable option offering nearby services with payment in-kind or instalments.

Once a person has made up their mind to access surgery the route to obtaining care can be complex. Patients in Sierra Leone report being turned away by local facilities because of a lack of space or staff. The route to obtaining care can be a long one and with variable quality or the absence of first aid along the way, results in an injury or condition that is worsened. The eventual care can become much more invasive. Delays resulting from inadequate finance, lack of knowledge and inappropriate care can, for example, turn a wound that required basic first aid into an eventual amputation.

These barriers demonstrate the need for interventions that focus not only on what happens inside hospitals but what happens outside as well. Systems to enable communities to understand the importance of early care and where to seek services and financial mechanisms to assist people help are needed. These don’t need to be invented from scratch. There is considerable experience in other sectors such as maternal health and tuberculosis services of enabling patients to overcome these ‘demand-side’ barriers. Learning across sectors is needed in order to help families and communities access services they need and reduce the huge gap between the need and use of surgical care.


RAIS – Retractor for Abdominal Insufflation-less Surgery

RAISRetractor for Abdominal Insufflation-less Surgery

Introduction: To complement our work in developing the Gas Insufflation-Less Laparoscopic Surgery (GILLS) Registry and TARGET training program, the GHRG-ST (in collaboration Pd-m International and partners in India) have developed and evaluated a prototype of an innovative new device to perform abdominal wall lifting during GILLS surgery.  By designing a device that is easy for surgeons working in low-resource, remote locations to sterilise, transport, manufacture, maintain and afford, the team aim to make using the GILLS technique and hence minimally invasive surgery a reality for rural surgeons across the country.

 

 

 

 

 

 

 

 

 

Design and Innovation: Our team conducted this work by applying principles of participatory design and frugal innovation to develop the final design: RAIS (Retractor for Abdominal Insufflation-less Surgery).  These are both widely recognised approaches for designing high-quality medical devices for low-resource healthcare environments.  Participatory design has involved our team working closely with surgeons and other healthcare professionals in India, firstly to understand their needs, then moving to a continual dialogue in which we discussed, evaluated and adapted the design as it developed.  Frugal Innovation has helped provide a sustained focus for the project: to innovate a cost-effective solution which focuses on core functionalities while optimising performance and quality.

End-user Evaluation: Our design and development process led to the production of a high-fidelity prototype system.  A workshop was convened at the 2019 Association of Rural Surgeons in India Conference to evaluate the system with our surgical and healthcare professional partners from India, together with an international audience of conference delegates and organisers.  In the workshop, we worked with the host institution (BVV Sangha’s S. Nijalingappa Medical College, Bagalkot, India) to deliver a series of training, evaluation and feedback sessions to assess the surgical performance of RAIS, using cadaveric models and simulated surgical procedures.  As well as considering different aspects of usability and surgical efficacy, rural surgeons were asked to evaluate ease of cleaning, maintaining, repairing and transporting the system in a low-resource environment, from their experience. We also presented the design development work to conference delegates to showcase how this innovative approach to rural surgery can be supported by innovations in engineering and surgical instrument design.  A summary of our cadaveric evaluation can be seen here (55sec).

Design Optimisation: The evaluation event highlighted that the RAIS system provides a good surgical experience, with surgeons readily able to setup, adjust and manipulate the system during a variety of surgical scenarios.  The design team were present to observe and debrief participants, a process which provided a wealth of information for a second stage of design – ‘optimisation’.   The optimisation process focused on incremental improvements to improve usability and robustness, for example ensuring that clamps can be safely operated with gloved hands whilst maintaining sterility. The resultant system, shown below, meets the stringent set of clinical requirements that were developed at the start of the project.

Next Steps: The next phase of our work is to address manufacture – refining the system such that it can be produced cost-effectively, and consistently, by partnering with medical device manufacturing experts in India. The resultant system will be evaluated with healthcare professionals in the UK, India and Africa to ensure it maintains the high standards we require. At this point, we will address aspects of regulatory approval and commercialisation, working with our manufacturing partner, so that the RAIS system can be made commercially available to help global surgeons practising GILLS across the word. Finally, when the device is finalised, we will develop a comprehensive training package tailored for a global audience. This will be achieved in collaboration with both our partners in rural healthcare centres in India and with Medical Aid International, a solutions expert in medical equipment for developing countries. This training package will help ensure that the device is sterilised, used, maintained and stored safely in challenging low-resource environments.

 


LAParoscopic Simulator in a PACKet

Laparoscopic surgery is the gold standard treatment for many conditions but limited access to expensive equipment limits its adoption globally [1].  It has been reported that there are 143 million additional surgical procedure needed annually [2] and 18 million of these could be amenable to a laparoscopic approach.  Despite such huge demand, its adoption is limited due to non-affordability of simulator in both developing countries and developed countries.

LAP-PACK is a low-cost simulator for training in laparoscopic surgery.  It is designed as a collapsible, portable flat pack trainer with following features:

  1. Ultra-low cost, sturdy, light-weight corrugated plastic builds its structure.  The rationale behind using it was to simulate the roughness of human abdominal organs, which was supported by clinical surgeons in the GHRG-ST team.
  2. Endoscopic camera with integrated light for illuminating the operative field.  This camera is compatible with tablet, phone and computer screens. It could be manually adjusted to change the depth of view and zoom into the surgical task.
  • Elastic wall for simulating abdomen and laparoscopic ports where trainees could create ports as per their comfort of training.

Lap-Pack has been designed in order to address the barriers in laparoscopic training like, (i) limited access to expensive specialist commercial equipment, (ii) time-intensive training requiring a skilled mentor, and (iii) monitoring the adequacy of acquired skills.

Lap-Pack is useful for trainees as a home-based or hospital based training equipment which has been used to provide training to 7 North-East India rural surgeons in Kolkata (March 2019), 35 trainees in Maulana Azad Medical College, Delhi (July 2019), 15 trainees in St. James Hospital, Leeds (August 2019) and 25 trainees in rural Karnataka, India (November 2019).  All these studies were conducted under GHRG-ST using TARGET training protocol [4].

Having produced from locally available materials, the Lap-Pack has several features which enhances its usability and provides flexibility of use in limited resource setting.  After successful training session in 2019, Lap-Pack has been requested for being available as a personal training equipment from a large number medical trainees in India and Africa since January 2020.

References:

[1] Chao, T. E., Mandigo, M., Opoku-Anane, J. & Maine, R. Systematic review of laparoscopic surgery in low- and middle-income countries: benefits, challenges, and strategies. Surg. Endosc. Other Interv. Tech. 30, 1–10 (2016).

[2] Meara, J. G. et al. The Lancet Commissions Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. www.thelancet.com 386, 569 (2015).


Immersive Techonologies

In November 2019 we ran a lower limb amputation course, which used immersive technologies as part of the pre course materials.  Click here to hear perspectives of the first users.