The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Webb, Millie Marriott; Bridges, Philippa; Aruparayil, Noel; Chugh, C; Beacon, T.; Singh, T; Sawhney, S S; Bains, Lovenish; Hall, Richard S.; Jayne, David; Gnanaraj, J; Mishra, Anurag; Culmer, Peter

doi:10.1109/jtehm.2022.3177313

Cited by 4 publications

(3 citation statements)

References 37 publications

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“…In the Delhi RCT, the reasons for conversion were inadequate space and complex anatomy [ 7 ]. Continued research on gasless lift devices has shown better usability in the low resource setting and may improve the operative experience and offer a comparable single quadrant field view to that of conventional laparoscopy [ 23 ]. Careful selection of patients is essential for better outcomes in the early stages of the learning curve.…”

Section: Discussionmentioning

confidence: 99%

Gasless laparoscopy in rural India-registry outcomes and evaluation of the learning curve

Aruparayil,

Gnanaraj,

Mishra

et al. 2023

Surg Endosc

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Background A program of gasless laparoscopy (GL) has been implemented in rural North-East India. To facilitate safe adoption, participating rural surgeons underwent rigorous training prior to independent clinical practice. An online registry was established to capture clinical data on safety and efficacy and to evaluate initial learning curves for gasless laparoscopy. Methods Surgeons who had completed the GL training program participated in the online RedCap Registry. Patients included in the registry provided informed consent for the use of their data. Data on operative times, conversion rates, perioperative complications, length of stay, and hospital costs were collected. Fixed reference cumulative sum (CUSUM) model was used to evaluate the learning curve based on operative times and conversion rates published in the literature. Results Four surgeons from three rural hospitals in North-East India participated in the registry. The data were collected over 12 months, from September 2019 to August 2020. One hundred and twenty-three participants underwent GL procedures, including 109 females (88.6%) and 14 males. GL procedures included cholecystectomy, appendicectomy, tubal ligation, ovarian cystectomy, diagnostic laparoscopy, and adhesiolysis. The mean operative time was 75.3 (42.05) minutes for all the surgeries. Conversion from GL to open surgery occurred in 11.4% of participants, with 8.9% converted to conventional laparoscopy. The main reasons for conversion were the inability to secure an operative view, lack of operating space, and adhesions. The mean length of stay was 3 (2.1) days. The complication rate was 5.7%, with one postoperative death. The CUSUM analysis for GL cholecystectomy showed a longer learning curve for operative time and few conversions. The learning curve for GL tubal ligation was relatively shorter. Conclusion Gasless laparoscopy can be safely implemented in the rural settings of Northeast India with appropriate training programs. Careful case selection is essential during the early stages of the surgical learning curve.

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Section: Discussionmentioning

confidence: 99%

Gasless laparoscopy in rural India-registry outcomes and evaluation of the learning curve

Aruparayil,

Gnanaraj,

Mishra

et al. 2023

Surg Endosc

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“…A more recent device, the Retractor for Abdominal Insufflation-less Surgery (RAIS), aims to provide a modern and portable system for GILLS, compatible with modern sterilisation methods, and is now in the early stages of clinical use. 5…”

Section: Dear Editormentioning

confidence: 99%

Gasless Laparoscopic Surgery-A Technique Requiring Multidisciplinary Collaboration to Improve Equitable Access to Surgery Worldwide

et al. 2022

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We read your recent article about the KeyLoop surgical retractor with interest and applaud the authors for their comprehensive and innovative evaluation of the device. Despite the various advantages of laparoscopic surgery (eg lower pain, earlier return to activity (and work), fewer wound infections, and shorter hospital stays) its implementation in low and middle-income countries (LMICs) is challenging due to factors including limited consumables, scarcity of funding and the risk of power outages, especially in rural regions. 1,2 To address these numerous challenges requires innovative solutions. Frugal technology and modified surgical techniques, such as Gas Insufflation-Less Laparoscopic Surgery (GILLS), provide the opportunity to ameliorate this trend and provide more equitable access to laparoscopic surgery in low-resource settings.The authors report that the methods, safety profile, and surgical outcomes of using gasless devices are not well described. However, a recently published systematic review included 3620 patients across 63 studies and concluded that GILLS has advantages for selective general and gynaecological procedures and may have a vital role to play in low resource settings. 3 Gasless laparoscopic surgeries using abdominal wall lifting devices (or retractors) started in 1990, but declined in popularity due to perceived suboptimal surgical exposure, despite a reduction in adverse cardiovascular and respiratory effects. However, in the recent decade this trend has begun to change with the introduction of improved retraction devices for GILLS. The Staan Laparoscopy Positioner has been in use since 2013 in remote and rural areas of India and is mentioned in the WHO compendium of innovative health technologies (2016-17) for low-resource settings. 4 To date, the Staan device has been used in many gasless laparoscopic surgeries. A more recent device, the Retractor for Abdominal Insufflation-less Surgery (RAIS), aims to provide a modern and portable system for GILLS, compatible with modern sterilisation methods, and is now in the early stages of clinical use. 5

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“…Other initiatives further leverage context-driven approaches to consider factors critical to the healthcare system in LRS throughout the medical device design process. This is demonstrated in the context-driven design of an electrosurgical unit ( 49 ) or the context-driven design of a retractor for abdominal insufflation-less surgery ( 50 ).…”

Section: Introductionmentioning

confidence: 99%

Design of a syringe extension device (Chloe SED®) for low-resource settings in sub-Saharan Africa: a circular economy approach

Samenjo,

Ramanathan,

Gwer

et al. 2023

Front. Med. Technol.

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Underfunded healthcare infrastructures in low-resource settings in sub-Saharan Africa have resulted in a lack of medical devices crucial to provide healthcare for all. A representative example of this scenario is medical devices to administer paracervical blocks during gynaecological procedures. Devices needed for this procedure are usually unavailable or expensive. Without these devices, providing paracervical blocks for women in need is impossible resulting in compromising the quality of care for women requiring gynaecological procedures such as loop electrosurgical excision, treatment of miscarriage, or incomplete abortion. In that perspective, interventions that can be integrated into the healthcare system in low-resource settings to provide women needing paracervical blocks remain urgent. Based on a context-specific approach while leveraging circular economy design principles, this research catalogues the development of a new medical device called Chloe SED® that can be used to support the provision of paracervical blocks. Chloe SED®, priced at US$ 1.5 per device when produced in polypropylene, US$ 10 in polyetheretherketone, and US$ 15 in aluminium, is attached to any 10-cc syringe in low-resource settings to provide paracervical blocks. The device is designed for durability, repairability, maintainability, upgradeability, and recyclability to address environmental sustainability issues in the healthcare domain. Achieving the design of Chloe SED® from a context-specific and circular economy approach revealed correlations between the material choice to manufacture the device, the device's initial cost, product durability and reuse cycle, reprocessing method and cost, and environmental impact. These correlations can be seen as interconnected conflicting or divergent trade-offs that need to be continually assessed to deliver a medical device that provides healthcare for all with limited environmental impact. The study findings are intended to be seen as efforts to make available medical devices to support women's access to reproductive health services.

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The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Cited by 4 publications

References 37 publications

Gasless laparoscopy in rural India-registry outcomes and evaluation of the learning curve

Gasless laparoscopy in rural India-registry outcomes and evaluation of the learning curve

Gasless Laparoscopic Surgery-A Technique Requiring Multidisciplinary Collaboration to Improve Equitable Access to Surgery Worldwide

Design of a syringe extension device (Chloe SED®) for low-resource settings in sub-Saharan Africa: a circular economy approach

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