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

Istituto Auxologico Italiano

Status: Not yet enrolling

Conditions: Ventral Hernia Repair

Study type: Observational

Funder types: Other

Identifiers

NCT07384962

38X502

Details and patient eligibility

About

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.

Enrollment: 790 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adults aged 18 years or older.
• Patients who previously underwent minimally invasive ventral hernia repair (primary, incisional, or recurrent) with intraperitoneal or extraperitoneal mesh placement.
• Patients scheduled to undergo elective or emergency minimally invasive abdominal surgery for any indication (including, but not limited to, hernia recurrence, bowel obstruction, cholecystectomy, colorectal, or gynecologic procedures).
• Patients in whom an initial minimally invasive approach is attempted, even if conversion to open surgery occurs after exploratory access or adhesiolysis.
• Ability to provide written informed consent, according to local regulations.

Exclusion Criteria

• Patients undergoing primary open abdominal surgery without an initial minimally invasive approach.
• Patients with a history of open ventral hernia repair as the index hernia procedure.
• Patients without available information on prior mesh position.
• Patients who decline or are unable to provide informed consent.

Trial design

790 participants in 2 patient groups

Intraperitoneal mesh

Description:

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.

Extraperitoneal mesh group

Description:

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.