In November 2016, the GlobalSurg collaborative of surgeons, including a number of ESCP members, met in Birmingham (UK) to plan their next trial. The group aims to develop 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.

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.”

Future plans and ESCP collaboration

The significance of GlobalSurg’s future randomised controlled trial extends beyond its measurable outcomes. However the wide inclusion criteria of the proposed trial mean that the results will have a direct impact on the full range of colorectal surgery: laparoscopic and open, elective and emergency. 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. ESCP members are linked around the world and you may know of surgeon collaborators in low and middle income settings who may wish to take part in this trial. We are still open to new collaborator surgeons so please get in touch or pass on our contact details.

Author Bio: Aneel Bhangu (@aneelbhangu) is a Clinical Lecturer in Colorectal Surgery at the University of Birmingham, Chief Investigator of the GlobalSurg-RCT and a member of the ESCP Cohort Studies Sub-Committee. Rebecca Morton is a Birmingham based blogger.

Declarations: 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.

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