Planning a network for randomised trials in global surgery

Surgery has been called the “neglected stepchild” of global health. Of the surgical research that is done, virtually none of it is relevant to patients and surgeons in resource limited settings. GlobalSurg is a collaborative of surgeons and methodologists who are developing pragmatic, patient facing research focused on low and middle income countries (LMICs). Since its foundation in 2013, GlobalSurg has run two observational studies in abdominal surgery, involving 25 000 patients from over 100 countries.

One of these preliminary studies found that surgical site infections (SSIs) were twice as common in LMICs compared to high income settings. These infections have a huge impact on patients, leading to long stays in hospitals, increased costs, and preventing their early return to work. Loss of income combined with medical and transport costs add to the economic burden on patients and their families. For a patient living in a remote village in South Africa, miles from the nearest hospital, a post-surgery infection could be fatal.

These studies have provided baseline data that have enabled us to begin planning a randomised trial targeting the reduction of SSIs.

On 6 November 60 medical professionals from across the globe converged in Birmingham for a two day conference aiming to design this world first trial. Among the group were 25 surgeons from Benin, Egypt, Ghana, Guatemala, India, Mexico, Nigeria, Pakistan, Peru, Philippines, Rwanda, and South Africa. The meeting was supported by a UK based MRC-Wellcome-DFID Joint Global Health Trials development grant. The surgeons selected two interventions to test: a 2% alcoholic chlorhexidine skin preparation and a clean set of wound closure instruments.

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Adesoji Ademuyiwa, a paediatric surgeon from Nigeria, said that “putting surgery on the public health agenda at a national and international level is my passion. In the 1980s HIV gained international coverage and as a result great progress was made. I want to see the same happen with the application of surgery for trauma victims, as well as in cancer treatment and oncology so that we can improve outcomes for patients.”

Planning the trial involved small group work and led to a lot of lively discussions, including a focus on the heterogeneity of the study network. Philip Alexander, working in a 50 bed hospital in the foothills of the Indian Himalayas, spoke of the practical difficulties of a trial participant returning for a follow-up appointment in winter when roads could be impassable. In Rwanda, many patients would be unable to pay the transport costs to return to hospital. Innovative methods, such as using smartphones to send pictures of wounds or outreach visits to the patient’s home, were discussed to maximise follow-up within a trial.

While patient involvement in the planning and conducting of clinical trials is common practice in the UK, it is rare in LMICs. Patient representatives from both the UK and Rwanda were present at our meeting, enabling differing experiences across the globe to be compared. Emmy Runigamugabo, a patient representative for GlobalSurg in Rwanda, noted that “patients in Rwanda will be happy to help with research that will help improve hospital care. At home, our patients often have long and difficult journeys to the hospital, and for people to come back if they are sick because of infections is a serious issue that means they will have to rely on the help of others to return for treatment.”

The significance of GlobalSurg’s future randomised controlled trial extends beyond its measurable outcomes. The study will create new research leaders in countries where they are currently lacking. We will look to submit a funding application in 2017 to support a major randomised trial. We are still open to new collaborator surgeons from low and middle income settings so please get in touch (www.globalsurg.org) .

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Aneel Bhangu is a clinical lecturer in colorectal surgery at the University of Birmingham and chief investigator of the GlobalSurg-RCT (aneelbhangu@gmail.com, Twitter @aneelbhangu).

 

Rebecca Morton and Tom Morton are Birmingham based bloggers.

Declaration of competing interests: The meeting was supported by an MRC-Wellcome-DFID Joint Global Health Trials Development grant. Additional funding was supplied by CareFusion, 3M, Birmingham City Council, and Queen Elizabeth Hospital Birmingham Charity.