Design of a comparative outcome analysis of open,laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model |
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| Affiliation: | 1. Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK;2. MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK;3. Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany;4. Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria;5. Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania;6. School of Public Health, Georgia State University, Atlanta, GA, USA;7. Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK;8. Department of Psychology, University of Cape Town, Cape Town, South Africa;9. Institute for Marriage, Family and Systemic Practice – ALTERNATIVA, Skopje, North Macedonia;10. Health for Youth Association, Chișinău, Republic of Moldova |
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| Abstract: | BackgroundIn a recent publication, the International Guidelines for Groin Hernia Management by the European Hernia Society (EHS) recognized the need to individualize and tailor the surgical approach for hernia repair. There may be different opportunities for optimization of the surgical technique for surgeons performing open, laparoscopic, or robotic-assisted hernia repair. Robotic-assisted hernia repair is a relatively new minimally invasive surgical approach compared to laparoscopic and open repair. Currently, there is a lack of comparative prospective studies designed to evaluate long-term outcomes of patients undergoing robotic-assisted, laparoscopic, or open hernia repair.Materials & methodsThis manuscript presents an innovative study design with two study cohorts (incisional and inguinal hernia repair) that contain three arms (robotic-assisted, laparoscopic, and open). The trial objective is to collect short-term and long-term outcomes for patients undergoing robotic-assisted, laparoscopic, or open hernia repair. The present publication will discuss the trial design, methods used to ensure consistency in surgeon expertise, and provides strategies to obtain long-term (> 3 months) follow-up data for enrolled patients.ResultsOne hundred subjects underwent incisional and one hundred underwent inguinal hernia repair at the time of this manuscript. Surgeon experience was analyzed across the three surgical techniques and follow-up compliance was assessed through 1 year. The follow-up completion rates for both study cohorts were >80% for all visits.ConclusionsThe innovative trial design helped to improve the quality and quantity of long-term follow-up. More innovative options to improve patient retention may be tested in future trials of similar design. |
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