Clinical Research Directory

ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery

Ventral hernia repair is one of the most commonly performed abdominal surgical procedures worldwide, increasingly carried out using minimally invasive techniques. In this setting, mesh reinforcement is standard practice, but the optimal anatomical plane for mesh placement remains debated. Intraperitoneal and extraperitoneal mesh positions may have different long-term consequences, particularly when patients undergo subsequent abdominal surgery. However, prospective data evaluating the impact of prior mesh position on reoperative risk and postoperative outcomes are limited. The ORION study is a prospective, multicentre, observational cohort study designed to evaluate the impact of prior minimally invasive ventral hernia repair with intraperitoneal versus extraperitoneal mesh placement on subsequent minimally invasive abdominal surgery. The primary objective is to compare the incidence of intraoperative visceral injury during adhesiolysis between the two mesh positions. Secondary objectives include the assessment of adhesion burden and severity, duration and extent of adhesiolysis, conversion to open surgery, and adhesion-related postoperative complications. In a predefined subgroup of patients undergoing surgery for ventral hernia recurrence, the study also evaluates short-term postoperative outcomes, including chronic post-surgical pain, neuropathic pain features, sensory disturbances, and analgesic use. By prospectively collecting standardized intraoperative and postoperative data across multiple centres, the ORION study aims to provide real-world evidence on the long-term surgical and functional implications of mesh positioning in minimally invasive ventral hernia repair.

Effect of Pressure Biofeedback Training After Ventral Hernioplasty

The goal of this clinical trial is to evaluate the effect of pressure biofeedback training on abdominal muscle strength and quality of life in adults following ventral hernioplasty. The main questions it aims to answer are: * Is there a significant effect of pressure biofeedback training on abdominal muscle strength in patients following ventral hernioplasty? * Is there a significant effect of pressure biofeedback training on quality of life in patients following ventral hernioplasty? Researchers will compare the effect of adding pressure biofeedback training to a conventional physical therapy program versus a conventional physical therapy program alone to determine whether pressure biofeedback training provides additional benefits in improving abdominal muscle strength and quality of life following ventral hernioplasty. Participants in the study group will receive pressure biofeedback training in addition to the conventional physical therapy program, while participants in the control group will receive the conventional physical therapy program only.

Opioid Education Ventral Hernia Repair

The goal of this study is to learn if opioid education before surgery affects prescribed opioid use after surgery in participants who are undergoing a ventral hernia repair. The main question it aims to answer is, does opioid education before surgery lower the number of opioid pills taken during recovery after a ventral hernia repair? Researchers will compare participants who watch an opioid education video before surgery to participants who watch a ventral hernia repair education video before surgery to see if those who watch an opioid education video take less prescribed opioid pills during recovery. Participants will watch a roughly 2-minute video in office the day their ventral hernia repair is scheduled, watch the same video the day of their surgery and be asked to report how many prescription opioid pills they took during recovery and return any left-over prescription opioid pills for disposal at their 1 month follow up appointment.

Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias

Patients with large, complex, or giant incisional hernias often require advanced preoperative optimization to facilitate safe abdominal wall reconstruction and reduce postoperative complications. Several strategies are currently used in clinical practice, including botulinum toxin A injection, progressive preoperative pneumoperitoneum, and their combination. However, the optimal differentiated approach based on hernia characteristics and abdominal wall tissue deficiency remains unclear. This study aims to compare the effectiveness and safety of different preoperative preparation strategies in patients with large postoperative ventral hernias and loss of abdominal wall domain. Outcomes of patients receiving botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preparation will be analyzed. The study will evaluate operative feasibility, ability to achieve fascial closure, postoperative complications, recurrence, and overall treatment outcomes.

Cost-Effectiveness of Retromuscular Hernia Repair

This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.