Short-term outcomes and inflammatory stress response following laparoscopy or robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP): study protocol for a prospective, randomized trial (ROLAIS)

• Published in: Current controlled trials in cardiovascular medicine Vol. 25; no. 1; pp. 529 - 15
• Main Authors: Valorenzos, Alexandros Valsamidis, Nielsen, Kristian Als, Kaiser, Karsten, Helligsø, Per, Ellebæk, Mark Bremholm, Dorfelt, Allan, Petersen, Sofie Ronja, Pedersen, Andreas Kristian, Nielsen, Michael Festersen
• Format: Journal Article
• Language: English
• Published: England BioMed Central 08-08-2024; BMC
• Subjects: Anatomical; C-Reactive Protein - analysis; C-Reactive Protein - metabolism; Chronic pain; Cytokines; Cytokines - blood; Denmark; Ergonomics; Hernia; Hernia, Inguinal - surgery; Hernias; Herniorrhaphy - adverse effects; Herniorrhaphy - methods; Hospitals; Humans; Infections; Inflammation; Informed consent; Inguinal; Intervention; Laparoscopy; Laparoscopy - adverse effects; Laparoscopy - methods; Male; Medical research; Outpatient care facilities; Pathological conditions; Patients; Postoperative Complications - etiology; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Robotic surgery; Robotic surgical procedures; Robotic Surgical Procedures - adverse effects; Robotic Surgical Procedures - methods; Study Protocol; Surgeons; Time Factors; Treatment Outcome; Denmark; Hernia; Inguinal; Pathological conditions; Robotic surgical procedures; Anatomical
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08361-w

Inguinal hernia repair is a frequently performed surgical procedure, with laparoscopic repair emerging as the preferred approach due to its lower complication rate and faster recovery compared to open repair. Mesh-based tension-free repair is the gold standard for both methods. In recent years, robotic hernia repair has been introduced as an alternative to laparoscopic repair, offering advantages such as decreased postoperative pain and improved ergonomics. This study aims to compare the short- and long-term outcomes, including the surgical stress response, postoperative complications, quality of life, and sexual function, between robotic-assisted transabdominal preperitoneal (rTAPP) and laparoscopic TAPP inguinal hernia repairs.
This randomized controlled trial will involve 150 patients from the Surgical Department of the University Hospital of Southern Denmark, randomized to undergo either rTAPP or laparoscopic TAPP. Surgical stress will be quantified by measuring C-reactive protein (CRP) and cytokine levels. Secondary outcomes include complication rates, quality of life, sexual function, and operative times. Data analysis will adhere to the intention-to-treat principle and will be conducted once all patient data are collected, with outcomes assessed at various postoperative intervals.
This study holds significance in evaluating the potential advantages of robotic-assisted surgery in the context of inguinal hernia repairs. It is hypothesized that rTAPP will result in a lower surgical stress response and potentially lower the risk of postoperative complications compared to conventional laparoscopic TAPP. The implications of this research could influence future surgical practices and guidelines, with a focus on patient recovery and healthcare costs. The findings of this study will contribute to the ongoing discourse surrounding the utilization of robotic systems in surgery, potentially advocating for their broader implementation if the benefits are substantiated.
ClinicalTrials.gov NCT05839587. Retrospectively registered on 28 February 2023.