GlobalSurg Randomised Trial Planning Conference
GlobalSurg is a group of collaborative general surgeons and methodologists who are developing pragmatic, patient facing research focussed 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 a hundred countries. This has provided baseline data allowing us to begin planning a randomised trial targeting reduction of surgical site infection (SSI). Our data shows that SSI affects 1 in 5 of all patients, but that increases to 1 in 2 patients in low income settings undergoing contaminated surgery.
We will aim to present some of these results at RCS’s Global Surgical Frontiers Conference on Friday 21st April, 2017. RCSEng has strongly supported development of UK led trainee collaboratives over the last five years and we are continuing this partnership in development of Global networks. This includes support from both Research and International Development departments to achieve wider scope. RCS’s ability to provide global linkage of surgeons and Surgical Societies will enhance GlobalSurg’s collaborations around the world.
GlobalSurg trial planning meeting
Sixty medical professionals from across the globe converged in Birmingham on November 6th for a two-day conference aiming to design this world first trial. Amongst 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 Trials Development grant. The surgeons selected two interventions to test: 2% alcoholic chlorhexidine skin preparation and a clean set of wound closure instruments. The designs discussed will allow a change in practice to be left behind irrespective of the trial’s results.
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 involved lively discussion and small group work, including focus on the heterogeneity of the network. Philip Alexander, working in a fifty-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.
Impact to patients
Our preliminary study found that SSI was twice as common in LMICs compared to high income settings. They have a huge impact on patients, leading to long stays in hospitals, increased costs to patients, and preventing 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.
Patient and public involvement
Whilst 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 wide inclusion criteria of the proposed trial mean that the results will have a direct impact to a wide range of surgeons around the world. 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. This network will provide an infrastructure that will develop new and responsive research priorities from autonomous overseas hubs, that can be reciprocally delivered across the network.
Future plans involve developing a strong collaboration with RCSEng. This includes identifying new overseas surgeons to take part in trials, linking up National Surgical Colleges, and developing guidelines for implementation of trial results. We are still open to new collaborator surgeons so please get in touch or pass on our contact details to your colleagues.
Aneel Bhangu is a Clinical Lecturer in Colorectal Surgery at the University of Birmingham and Chief Investigator of the GlobalSurg-RCT (firstname.lastname@example.org, @aneelbhangu).
Rebecca Morton is a Birmingham-based blogger.
The meeting was supported by an MRC-Wellcome-DFID Joint Global Trials Development grant. Additional funding was supplied by CareFusion, 3M, Birmingham City Council, and Queen Elizabeth Hospital Birmingham Charity.