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How physicians in Canada invent new surgeries

A conversation with Dr. Sunit Das on ethical oversight in surgery innovation

How physicians in Canada invent new surgeries

Taking risks and testing new ideas are the cornerstones of advancing science and technology. But when it comes to developing new surgical techniques, experimentation can be a matter of life or death for patients who volunteer.

To understand how and why surgeons innovate, The Varsity interviewed Dr. Sunit Das, an Assistant Professor at U of T’s Department of Surgery and neurosurgeon at St. Michael’s Hospital. 

Why innovate?

Although the practice of surgery has come a long way, there is considerable potential to improve surgeries in order to make them safer, quicker, more efficient, and less expensive.

“Engineers talk about the fact that it’s the existence of problems that drive their work,” explained Das. “And, in a way, surgical innovation could say much the same.”

Of course, innovation inevitably carries the risk of failure. Das explained that part of the ethical dilemma of surgical innovation stems from weighing the benefits of testing an unfamiliar technique against a proven and well-known procedure. 

The difficulty of this decision depends on the effectiveness of existing procedures. When surgeons test a new technique against one that is rarely effective, ethically it might not be a costly risk to take. For example, according to Das, physicians can often test new chemotherapeutic agents with patients who have recurrent cancers, since there are usually no effective alternative therapies for their conditions.

New surgeries for these conditions are often worth the risks. It is much harder to try to innovate when a technique that is relatively safe and effective already exists.

For any innovative procedure, ethical practice requires doctors to fulfill certain responsibilities when offering experimental treatments to patients. Currently, there is a four-step process in place for approving new surgical techniques in Canada. 

The stages of surgical innovation

Surgical innovation begins with preclinical work and the development of a technique. Stage 1 follows, at which surgeons use the experimental technique for the first time on a human patient. In this early stage, the goal is to determine the safety and efficacy of the procedure in a small, select group of patients.

In Stage 2, surgeons apply the surgical procedure to a broader selection of patients to determine the reproducibility of Stage 1’s results. They also determine how to best apply the intervention, as well as develop the technique’s efficiency.

Throughout the development of any new surgery, patients and their caregivers must give special consent to receive it. This suspends or modifies the duty of surgeons to minimize harm. By the conclusion of Stage 3, the new surgery becomes a standard procedure, removing the need for physicians to require special consent from patients.

How do experimental surgeries receive ethical oversight?

Monitoring the progress of surgical innovation is critical — a lack of oversight could lead to mistakes that present patients with unnecessary risks.

For many hospitals, Research Ethics Boards (REBs) ensure experimental techniques meet ethical requirements. When surgeons intend to make an experimental procedure available for patients, they must submit a clearly defined protocol to an REB for approval.

However, there are drawbacks to placing an REB in charge of surgery. To start, REBs often do not have surgeons on them. Service on an REB is a time-consuming responsibility and “time is one of the things that surgeons tend to lack,” said Das.

An REB’s oversight can also substantially slow the development of a surgical technique, said Das, in ways he believes are unnecessary.

To develop a surgical technique, explained Das, researchers undergo a process that is iterative. That is, surgeons often apply an experimental technique, learn how they could improve it during the process of the surgery, and change the protocol to reflect the improvement.

“The nature of an REB is antagonistic to [iteration],” said Das. Under an REB’s oversight, each time the surgeons decide to alter their protocol, they need to apply for an amendment, causing their application to require review by the REB.

While Das noted that the additional review does ensure that the REB is on the same page as the surgeons, he believes that an alternative approval process could increase the efficiency of surgical innovation.

The Surgeon-in-Chief as an alternative source of oversight

Das believes in placing the burden of responsibility on the Surgeon-in-Chief of a hospital to ensure that experimental surgeries meet ethical requirements.

The expertise of the Surgeon-in-Chief addresses the first perceived shortfall of REBs — that such boards lack physicians directly experienced in surgery. He noted that “there are nuances to the idea of surgical innovation [that he believes] are more available to a Surgeon-in-Chief than they necessarily might be to an REB.”  This could allow the Surgeon-in-Chief to have a better grasp of how an experimental procedure works.

Das also addressed the issue of REBs reducing efficiency. He said that a Surgeon-in-Chief with the onus of responsibility would allow “a type of communication and a type of nimbleness to change that simply is not inherent to the way that something works with an REB” and would therefore support iterative development.

“I think Toronto has been a leader in the world in terms of thinking about this problem [of obstacles to iteration],” said Das. In fact, he noted that the model of placing the Surgeon-in-Chief of a hospital in charge of oversight, instead of an REB, evolved at Toronto General Hospital.

Since then, institutions, such as St. Michael’s Hospital and Toronto Western Hospital, have adopted this model of ethical approval. As an advocate of this approach, Das has co-authored a paper about this in The American Journal of Bioethics. 

He acknowledged, however, that the model does have shortfalls. “One of the inherent dangers to placing the oversight element to innovation with a Surgeon-in-Chief is that there might be [conflicts of interest] that could get in the way of proper oversight,” he said.

A conflict of interest, said Das, could result from the promise of prestige of a successful innovation overshadowing the Surgeon-in-Chief’s responsibilities to the hospital, surgeons, and patients to ensure proper oversight when approving experimental procedures.

“For me, being involved in surgical innovation has had beneficial effects on my career and on my standing in the international community of neurosurgery. I gain prestige by work that I do as an innovator… and the hospital gains prestige from the work that I do,” said Das.

“There’s the danger that those risks, those responsibilities could be clouded by the possibility of benefit in terms of prestige to a surgeon and to a hospital by innovation.”

Always innovating

Surgeons think about research ethics to address the conflict between the goals of securing patient safety and improving patient outcomes by developing new procedures. They cannot advance what they offer patients without stepping outside a place that is comfortable and known. Taking risks is fundamental to making progress.

“Surgical innovation in a way is deciding to do something differently, despite knowing that we have a way of doing things safely and well,” said Das. “It’s simply that we think we can finally do something that, in a way, will be safer and be better.”

New surgical technique allows doctors to add more organs to the donor pool

Two types of light-based therapies can sterilize donor organs prior to transplantation

New surgical technique allows doctors to add more organs to the donor pool

A new technique co-developed by U of T researchers uses light-based therapy to kill viruses in organs meant for transplantation. The method lets physicians treat human donor lungs infected with Hepatitis C, preventing viral transmission to the organ recipient.

The co-authors of the procedure, published in Nature, are hopeful that it could vastly increase the number of organs eligible for transplantation in North America.

The new surgical technique is based on existing methods

This technique uses an existing procedure known as ex-vivo lung perfusion. Here, after retrieval by practitioners, the lungs are placed in a chamber with a circuit and specific liquids flow through the organs’ vasculature.

During this circuit the solution passes through the lungs, washing out a lot of viruses. The newly developed technique uses a machine with two light-based therapies — namely, ultraviolet C irradiation and photodynamic therapy — to eventually sterilize the organs before the transplantation.

The research team developed a customized illumination device which is attached to the machine where perfused liquid passes through, irradiating the virus and therefore inactivating it with light.

The researchers aim to further develop the technique by treating the lungs themselves with light, not just the liquid that passes through them. To achieve this, more research is needed on the optical properties of the lungs to engineer new technology to illuminate them.

Adding organs to the donor pool

Co-author Dr. Marcos Galasso, a U of T thoracic surgeon and ex-vivo lung perfusion specialist, stressed the importance of this new technique in an interview with The Varsity.

“There is a great need for donor organs,” he said, “[which has led] to some people dying on the waiting list for transplantation.”

Galasso added that treating Hepatitis C-infected donor lungs alone could make a huge impact on the donor pool due to the opioid crisis gripping North America. He noted that most patients who die from drug overdoses test positive for the virus.

According to Galasso, if health care practitioners could add volunteers infected with Hepatitis C to the donor pool, there could between 1000 to 2000 new lung donors eligible per year in North America.

“We could actually have a massive impact in the organ donation environment in North America [with this surgical technique].”

‘Black box’ collects data from the operating room

U of T professor Teodor Grantcharov’s invention could improve medical outcomes

‘Black box’ collects data from the operating room

Akin to a black box in an aircraft, a black box in the operating room (OR) can provide valuable insights.

The OR black box records information during a surgery that is then analyzed to determine how interactions between the surgical team, the environment, and human components factor into patient outcomes.

Dr. Teodor Grantcharov, staff surgeon at St. Michael’s Hospital and professor in the Faculty of Medicine, developed the OR black box in 2017. One of the driving reasons for creating it is that the operating room can be secretive.

“The reason why we developed it is because we felt that we lack transparency, we lack data about our performance as surgeons, as teams, as organizations. We lack data from the operating room,” said Grantcharov.

“Nobody knows what happens there,” said Grantcharov. “Whatever happens there stays there, and we make mistakes, we have successes and failures, but we have very little opportunity to understand them, to study them, and to improve in the future.”

According to Grantcharov, the black box could change this and allow health care providers to recognize and learn from their mistakes, and improve medical outcomes for patients.

“Without data, we can’t improve, and we felt that the OR black box could provide some more insight and some more data that we could use to critically reflect and see opportunities to get better,” said Grantcharov.

The black boxes document everything that occurs in an operating room, and not just the surgical procedure.

It collects video recordings, audio, environmental factors like fluctuations in noise levels and temperature, and minute details like the opening and closing of doors. Furthermore, it collects information on the performance of the surgical team, patient physiology, and the instruments used.

Grantcharov added that the black box analyzes correlations “between performance and outcomes, between stress and performance, between fatigue and performance, and between communication and performance, in any particular outcome.”

Improvements in health care can be made from analyzing such data.

For example, data from the black box indicated that the more people were in the room, the higher the risk of an error.

“We looked at the policy of our hospital which was ‘keep room traffic to a minimum,’” explained Grantcharov.

“So now, we can say for this type of procedure, there shouldn’t be more than 10 people or eight people, and if there are more they [have to] come another day,” continued Grantcharov. “[We] can create the system where we reduce, we restrict access, we can create a system where we eliminate the external communication, especially in most critical steps of the procedure.”

Currently, OR black boxes are used at St. Michael’s Hospital, Humber River Hospital, and North York General Hospital.

To evaluate the effectiveness of the OR black box, Grantcharov and his team need sufficient data to observe trends and draw conclusions.

In fact, associate professor at the Dalla Lana School of Public Health Patricia Trbovich and her research team are using grants from the Natural Sciences and Engineering Research Council and the Ontario Centres of Excellence to examine the data black boxes collect and their overall effectiveness.

The instrument also allows medical staff from around the world to learn from one another.

“We can see, if we do something here and a team of surgeons does the same thing in Amsterdam… what are the things that we do better than them so that they can learn from us,” said Grantcharov. “And we want to see what are the things they do better than us so we can learn from them. There is always something to learn from others.”

The OR black box has been used for minimally invasive procedures like laparoscopic surgeries, in which operations happen through small incisions with the aid of a camera. But Grantcharov added that the black box can capture data from any procedure, even ones outside of the OR.

For Grantcharov, the optimal achievement of the OR black box lies in culture change.

“[It can] allow us to make surgery more open, more transparent, and less mystical for patients. [It makes] the operating room more collaborative,” said Grantcharov.