Ventral Hernia RepairORIONNCT07384962
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
An observational study of Ventral Hernia Repair, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Repair
- How many people
- 790 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2026to 31 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Impact of Prior Ventral Hernia Repair on Subsequent Reoperations and Neurological Sequelae, Comparing Intra-peritoneal vs. Extra-peritoneal Mesh Placement: the ORION Study
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.
Read more
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.
- Conditions
- Ventral Hernia Repair
- Keywords
- ventral hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal mesh | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the subsequent minimally invasive abdominal surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start30 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384962
- Sponsor's protocol ID
- 38C501
- Acronym
- ORION
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pelfini E, Lauricella S, Nisi A, Dionigi G, Brucchi F. The ORION study protocol: impact of prior intraperitoneal versus extraperitoneal mesh placement on subsequent minimally invasive abdominal reoperations. J Abdom Wall Surg. 2026 Sep 18;5:17325. doi: 10.3389/jaws.2026.17325. eCollection 2026.
PubMed 42827743