An observational study in Ventral Hernia Repair, sponsored by Istituto Auxologico Italiano. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Istituto Auxologico Italiano · Observational
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 790 is above the median of 132 across 65 observational studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
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The study population includes adult patients (≥18 years) with a history of minimally invasive ventral hernia repair involving prosthetic mesh placement, who subsequently undergo elective or emergency minimally invasive abdominal surgery for any indication. Patients are grouped according to the anatomical position of the previously implanted mesh, classified as intraperitoneal or extraperitoneal (preperitoneal or retromuscular).
The study population is designed to reflect real-world surgical practice and includes consecutive patients undergoing a wide range of abdominal procedures, including surgery for hernia recurrence and non-hernia-related indications. Both laparoscopic and robotic approaches are eligible. In patients undergoing surgery for ventral hernia recurrence, postoperative follow-up is performed to assess early surgical, neurological, and patient-reported outcomes, while patients undergoing surgery for other indications are evaluated for intraoperative outcomes only.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes adult patients who previously underwent minimally invasive ventral hernia repair with intraperitoneal mesh placement, defined as a prosthetic mesh positioned within the peritoneal cavity in direct contact with the abdominal viscera. Mesh fixation methods may include sutures, absorbable or non-absorbable tackers, glue, or mixed techniques, according to standard clinical practice at the time of the index operation. Patients in this group undergo subsequent minimally invasive abdominal surgery for any indication and are prospectively evaluated for intraoperative findings and postoperative outcomes, including adhesions, visceral injury during adhesiolysis, and early postoperative morbidity.
This group includes adult patients who previously underwent minimally invasive ventral hernia repair with extraperitoneal mesh placement, defined as a prosthetic mesh positioned outside the peritoneal cavity, either in the preperitoneal or retromuscular plane. Mesh fixation methods may include sutures, absorbable or non-absorbable tackers, glue, or mixed techniques, according to standard clinical practice at the time of the index operation. Patients in this group undergo subsequent minimally invasive abdominal surgery for any indication and are prospectively evaluated for intraoperative findings and postoperative outcomes, including adhesions, visceral injury during adhesiolysis, and early postoperative morbidity.
Incidence of intraoperative visceral injury during adhesiolysis
The primary outcome is the occurrence of intraoperative visceral injury during adhesiolysis in patients undergoing subsequent minimally invasive abdominal surgery after previous minimally invasive ventral hernia repair. Visceral injury is defined as any unintended injury to abdominal organs, including serosal tears or full-thickness injuries of the small bowel, colon, or other intra-abdominal viscera, identified and recorded intraoperatively by the operating surgeon. The outcome will be compared between patients with prior intraperitoneal versus extraperitoneal mesh placement. The assessment is performed intraoperatively at the time of the subsequent surgical procedure.
Time frame: During the subsequent minimally invasive abdominal surgical procedure
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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