Standardised Competency-Based Training of Medical Doctors and Associate Clinicians in Inguinal Repair with Mesh in Sierra Leone.

INTRODUCTION: In low-income settings, there is a high unmet need for hernia surgery, and most procedures are performed with tissue repair techniques. In preparation for a randomized clinical trial, medical doctors and associate clinicians received a short-course competency-based training on inguinal hernia repair with mesh under local anaesthesia. The aim of this study was to evaluate feasibility, safety and effectiveness of the training. METHODS: All trainees received a one-day theoretical module on mesh hernia repair under local anaesthesia followed by hands-on training. Performance was assessed using the American College of Surgeon's Groin Hernia Operative Performance Rating System. Patients were followed up two weeks and one year after surgery. Outcomes of the patients operated on during the training trial were compared to the 229 trial patients operated on after the training. RESULTS: During three surgical camps, seven medical doctors and six associate clinicians were trained. In total, 129 patients were operated on as part of the training. Of the 13 trainees, 11 reached proficiency. Patients in the training group had more wound infections after two weeks (8.5% versus 3.1%; p = 0.041). There was no difference in recurrence and mortality after one year, and none of the deaths were attributed to the surgery. DISCUSSION AND CONCLUSION: Mesh repair is the international standard for inguinal hernia repair worldwide. Nevertheless, this is not widely accessible in low-income settings. This study has demonstrated that short-course intensive hands-on training of MDs and ACs in mesh hernia repair is effective and safe. TRIAL REGISTRATION: International Clinical Trial Registry ISRCTN63478884.

Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.

Importance: Task sharing of surgical duties with medical doctors (MDs) without formal surgical training and associate clinicians (ACs; health care workers corresponding to an educational level between that of a nurse and an MD) is practiced to provide surgical services to people in low-resource settings. The safety and effectiveness of this has not been fully evaluated through a randomized clinical trial. Objective: To determine whether task sharing with MDs and ACs is safe and effective in mesh hernia repair in Sierra Leone. Design, Setting, and Participants: This single-blind, noninferiority randomized clinical trial included adult, healthy men with primary inguinal hernia randomized to receiving surgical treatment from an MD or an AC. In Sierra Leone, ACs practicing surgery have received 2 years of surgical training and completed a 1-year internship. The study was conducted between October 2017 and February 2019. Patients were followed up at 2 weeks and 1 year after operations. Observers were blinded to the study arm of the patients. The study was carried out in a first-level hospital in rural Sierra Leone. Data were analyzed from March to June 2019. Interventions: All patients received an open mesh inguinal hernia repair under local anesthesia. The control group underwent operations performed by MDs, and the intervention group underwent operations performed by ACs. Main Outcomes and Measures: The primary end point was hernia recurrence at 1 year. Outcomes were assessed by blinded observers at 2 weeks and 1 year after operations. Results: A total of 230 patients were recruited (mean [SD] age, 43.0 [13.5] years), and all but 1 patient underwent inguinal hernia repair between October 23, 2017, and February 2, 2018, performed by 5 MDs and 6 ACs. A total of 114 patients were operated on by MDs, and 115 patients were operated on by ACs. There were no crossovers between the study arms. The follow-up rate was 100% at 2 weeks and 94.1% at 1 year. At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001). Conclusions and Relevance: These findings demonstrate that task sharing of elective mesh inguinal hernia repair with ACs was safe and effective. The task sharing debate should progress to focus on optimizing surgical training programs for nonsurgeons and building capacity for elective surgical care in low- and middle-income countries. Trial Registration: isrctn.org Identifier: ISRCTN63478884.