Rural Surgical Innovation: Victories, Challenges, and Opportunities

Edited Article

 

Abstract:

Surgical innovation is the introduction or implementation of a novel idea, process, technology, or

 

device designed to meet a specific surgical need. Innovation is critical to care provision in low

 

resources settings, which may be characterized by inadequate infrastructure and supplies, limited

 

workforce, patients with very low affordability. In the high-income setting, innovation often

 

improves processes or increases efficiency; in low-resource settings, innovation makes care

 

possible. Here, we highlight several innovations borne from low-resource settings, devised by

 

clever clinicians in order make care provision possible for their patient populations.

 

Introduction:

 

 

Surgical innovation is the introduction or implementation of a novel idea, process,

 

technology, or device designed to meet a specific surgical need.1 Innovation is critical to care

 

provision in low resources settings, which may be characterized by inadequate infrastructure and

 

supplies, limited workforce, patients with very low affordability. 1 In the high-income setting,

 

innovation often improves processes or increases efficiency; in low-resource settings, innovation

 

makes care possible.

 

 

Here, we highlight several innovations borne from low-resource settings, devised by

 

clever clinicians in order make care provision possible for their patient populations. We collected

 

data through discussions with experts in low-resource care provision, particularly individuals

 

with extensive experience in Indian rural surgery through working group meetings and panel

 

discussions leading up to and including at the Association of Rural Surgeons of India Conference

 

(Karad, India, Nov 2015) and the WHO Lancet Commission on Global Surgery India Surgical

 

Forum (New Delhi, India, March 2016). We focus on three innovations which have or could

 

benefit from an academic partnership, and we postulate on three distinct stages in the

 

development of an innovation, with different needs from the clinical, academic, and industrial

 

communities.

 

 

Delayed Abdominal Closure

 

 

In 1984, Dr. Oswaldo Borraez was a surgical resident in Bogotá, Colombia at the

 

Hospital San Juan de Dios, struggling in the operating room with a patient with severe

 

peritonitis.2 Abdominal closure was unsafe due to the risks of abdominal compartment

 

syndrome, so the abdomen would have to be left open for delayed closure. Dr. Borraez suggested

 

that a three-liter polyethylene bladder irrigation bag be cut open to be attached temporarily to the

 

edges of the patient’s abdominal wound.3 Not only would the bag provide a barrier between

 

abdominal contents and the outside world, its transparency would allow continuous visualization

 

of the viscera.4 The previous method of packing the abdomen with surgical towels was known to

 

increase the rate of infection and entero-atmospheric fistulas.2

 

 

The Bogotá bag for delayed abdominal closure represents an innovation that has been

 

assessed and successfully scaled worldwide. It is now the standard of care for the management of

 

the open abdomen2 as well as modern surgical textbooks.5 In this example, partnerships aided in

 

the original expansion of the method as a visiting trauma surgeon from the United States noted

 

the ingenuity of the innovation and its potential to change standard of care worldwide. The

 

international academic community conducted several retrospective studies on the safety and

 

efficacy of the colloquially termed ‘Bogotá bag’ that showed equivalent outcomes to alternative

 

management for delayed abdominal closure.6-10

 

 

Mosquito Net Mesh for Hernia Repair

 

 

Hernia repair is one of the most frequently performed surgeries around the world and has

 

been shown to be cost-effective even in low-resource settings.11,12 The most common method for

 

hernia repair in HICs involves implantation of a synthetic mesh to reinforce the inguinal floor.

 

Unfortunately, these meshes cost hundreds of dollars which is unaffordable in many low- and

 

middle-income countries (LMICs).13

 

 

Fortunately, in the early 1990’s, Indian surgeons Dr. Ravindranath Tongaonkar and Dr.

 

Brahmma Reddy noted mosquito net had a similar consistency, thickness, and durability to

 

commercial mesh. Mosquito net is widely available and cheap: several economic studies have

 

discussed the savings associated with using the mosquito net mesh, with one study estimating

 

that it was 0.1% of the price of a commercial mesh.13 Drs. Tongaonkar and Reddy used sterilized

 

mosquito net to replace synthetic mesh in hernia repair and reported excellent outcomes. Their

 

wound complication rates were low and they found no significantly different risk of infection

 

when compared to commercially available mesh.14-17

 

 

Though there is evidence that mosquito net mesh was used in a few LMICs, only recently

 

have a number of studies built upon this work.18-20 Microscopically, the strength and structure

 

was proven to be equivalent to commercially available meshes (Figure 1).17 And most notably, a

 

well-designed, highly-powered randomized controlled trial published in The New England

 

Journal of Medicine showed no significant difference in rates of hernia recurrence and

 

postoperative complications between mosquito net mesh and commercial mesh.20

 

 

Gasless Laparoscopy

 

 

In the 1980s, the introduction of laparoscopic techniques to surgery significantly dropped

 

patient morbidity associated with traditional open procedures.21-23 It has been said to have

 

changed the field of general surgery more dramatically than any other single event.21 However, it

 

can be difficult to perform in low resource settings, as it requires video-laparoscopic equipment,

 

monitors, carbon dioxide, an insufflator, and a well-trained anesthesiologist who can manage the

 

increased pressures in the peritoneal cavity. Thus, gasless laparoscopy was developed in order to

 

allow laparoscopic surgery to be performed under spinal anesthesia rather than general

 

anesthesia, using a device that physically raises the anterior abdominal wall rather than inflating

 

it with gas (Figure 2).

 

 

A few reports on gasless laparoscopy have supported its use in low-resource settings. A

 

randomized comparison of gasless versus traditional laparoscopic appendectomy in China

 

reported no change in the duration of the procedure, complications or length of hospital stay.24

 

Additionally, they reported a decrease in pain medicine requirements by the patient and

 

decreased total hospital costs.24 In multiple randomized controlled trials in gynecologic surgery,

 

no significant differences in outcomes were noted, but there was decreased surgical exposure and

 

increased technical difficulty associated with gasless laparoscopy when compared to traditional

 

laparoscopy.25,26 However, recent publications have shown that problems with exposure have

 

been addressed and single-incision surgeries are much easier with gasless laparoscopic

 

techniques.27-29

 

 

Discussion:

 

 

Each of these three innovations reveals notable roles for academic partnerships. With the

 

Bogotá bag, the need to temporarily close an abdomen safely was universal: it existed similarly

 

in the high- and low-resource setting. With mosquito net for hernia repair, the need is not

 

necessarily universal: high-resource settings are not looking for a cheaper mesh in order to make

 

care provision possible. However, it represents a surgical innovation that is inexpensive,

 

effective, and context appropriate. With gasless laparoscopy, the innovation has not been

 

properly evaluated and is thus not yet in a position to scale.

 

 

The Bogotá bag was rapidly scaled worldwide due to successful academic partnerships

 

and sharing of this methodology. In a large systematic review of all techniques for temporary

 

abdominal closure, the Bogotá bag technique maintained a lower incidence of fistulae and

 

abscesses with a similar mortality rate when compared to the other techniques.30 Thus, in the

 

low-resource setting, this method can be performed safely with widely available materials. This

 

same review also clearly elucidated the influence of the Bogotá bag: many modern techniques

 

incorporate the same principals as the original solution from Colombia.30

 

 

The use of mosquito net mesh for tension-free hernia repair takes modern techniques and

 

uses a cheaper, but similar, material as an innovation. It also represents an academic feat-of-

 

excellence that can be strived for and achieved in low-resource settings through bidirectional

 

research partnerships. The current evidence supporting mosquito net mesh for hernia repair is

 

incredibly strong, and academic and industrial partnerships should advocate for the appropriate

 

scaling of mosquito net for hernia repair in LMICs worldwide.

 

 

Similarly, gasless laparoscopy brings laparoscopic techniques to the low-resource setting

 

without the requirement for an anesthesiologist, resulting in a lower morbidity operation when

 

compared to an open surgery. However, further critical assessment is necessary to elucidate the

 

costs and benefits. This innovation represents an excellent opportunity for academic partnership

 

in research, as no adequately powered or methodologically-meticulous randomized controlled

 

study has been performed to date.

 

 

These three innovations each fit into one of three distinct stages for surgical innovations

 

that we are proposing: (1) Innovations that have been critically assessed and widely scaled, (2)

 

Innovations that have been critically assessed but not yet scaled, and (3) Innovations that require

 

critical assessment. Classifying innovations using this framework can assist in the prioritization

 

of partnerships and the investment in scaling surgical innovations in the low-resource setting. In

 

the first group, the existing partnerships are successful, and can modeled in similar settings. In

 

the second group, industry, non-governmental organizations (NGOs), and media should be

 

encouraged to widely disperse the strong clinical evidence supporting various innovations

 

globally. In the final group, academic and research partnerships can develop and implement

 

research to strengthen the evidence for or against any given innovation.

 

 

In the development of the academic partnerships, bi-directional benefits are essential.

 

Local innovators should be included as co-authors on publications and there should be ample

 

opportunity for further professional development. Unfortunately, this is not always the case. A

 

survey of clinicians in Uganda reported that visiting foreign physicians improved their medical

 

education, but despite cooperative research being conducted in Uganda, none of the Ugandan

 

doctors were published as coauthors.31 This represents a remaining gap in true, equal

 

partnerships.

 

 

On the other hand, there have been significant achievements in many LMICs, and the

 

global community should learn from these victories in order to succeed in similar contexts

 

worldwide. Academic partnerships for funding and increased research capacity between high-

 

and low-resource settings have been shown to be extremely effective and bi-directionally

 

beneficial.32-34 For example, professional surgical societies in Ireland and Australasia have

 

partnered with similar organizations in sub-Saharan Africa and the Pacific Islands, respectively,

 

to enhance the training of medical professionals.33

 

 

Additionally, innovators in LMICs aren’t well equipped to publicize or compete for

 

grants,33 medico-legal protections cause clinicians to hide their innovations,35 and innovations

 

take time, energy, and money to develop and scale effectively, especially when originating from

 

a low-resource setting.36-38

 

 

Innovations originating from the rural or low-resource setting have the potential to drive

 

and improve surgery today. Academic partnerships at the local-regional level as well as at the

 

international level between high-resource partners can result in a bi-directional beneficial

 

relationship. Critically assessing these rural innovations will not only save the lives of one

 

surgeon’s patients, but may more broadly apply to the lives of patients in similar circumstances

 

worldwide. Rigorously proven rural surgical innovations, such as mosquito net for hernia repair,

 

should be academically duplicated and scaled rapidly to increase access to surgical care around

 

the world.

 

As the global community seeks to scale up surgical care, it must take advantage of the

 

clever workarounds that reduce cost while improving or maintaining efficacy that clinicians have

 

devised to make care provision possible with minimal resources. Academia and industry must

 

also take note, and actively partner with clinician-inventors to rigorously evaluate for safety

 

while providing avenues for scale.