Ventral HerniaPRIORNCT06364306
oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias
A study testing Robotically-assisted ventral hernia repair (RVHR) and Open ventral hernia repair (OVHR) in people with Ventral Hernia and Incisional Hernia, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.
Trial summary
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Incisional Hernia, Abdominal Wall Defect
- What is being tested?
- Robotically-assisted ventral hernia repair (RVHR) and Open ventral hernia repair (OVHR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Jul 2026to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient age >18 years
- Informed consent obtained
- Transverse diameter of ventral hernia >4cm - 15cm
- Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment
Who cannot join
- precedent hernia treatment with mesh placement in the retromuscular space
- precedent anterior or posterior component separation or transversus abdominis release (TAR)
- active wound infection
- current cancer diagnosis
- presence of ileostomy, colostomy or ileal conduit
- liver disease defined by the presence of ascites
Show all 10Show fewer
- end-stage renal disease requiring dialysis
- need of an emergency surgery
- pregnancy
- Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City, 4058
Angehrn Fiorenzo, MD, +41 61 777 73 17, fiorenzo.angehrn@clarunis.ch
Julian Susstrunk, MD, Julian.suesstrunk@clarunis.ch
- Not yet recruiting
Spital Oberwallis, Visp
Visp, Valais, 3930
Sebastian Happ, MD, +41 27 604 33 33, Sebastian.happ@hopitalvs.ch
Germany1 site, 1 recruiting
- Not yet recruiting
Klinikum Kempten
Kempten (Allgäu), Bavaria, 87439
Bjorn Mueck, MD, +49 831 53 00, hernienzentrum@klinikverbund-allgaeu.de
About this study
Official title: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.
The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).
The main questions it aims to answer are:
length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.
Participants will:
Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
- Conditions
- Ventral Hernia, Incisional Hernia, Abdominal Wall Defect
- Being tested
- Robotically-assisted ventral hernia repair (RVHR), Open ventral hernia repair (OVHR)
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically-assisted ventral hernia repair (RVHR)Procedure or surgery
3 8mm robotic trocars are placed intraabdominally and the DaVinci Xi-robotic system is docked. Adhesiolysis from any adherent structures to the abdominal wall is performed. Incision of the lateral verge of the retromuscular space and retromuscular dissection. Superior and inferior cross-over to the contralateral retromuscular space and dissection of the hernia sac.
Unilateral or bilateral transversus abdominis release (TAR) is performed, if necessary. Running suture with absorbable barbed suture of the posterior rectus sheath and peritoneum, as appropriate. Synthetic retromuscular mesh placement with a mesh-size as large as the prepared surface allows. Closure of the anterior rectus sheath with absorbable barbed running suture. Port extraction, skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.
Open ventral hernia repair (OVHR)Procedure or surgery
Median laparotomy with a minimal length of the previous scar (in case of incisional hernia) and adhesiolysis is performed, where necessary, to liberate the abdominal wall and the ventral hernia from adhesions. Bilateral dissection of the posterior rectus sheath under visualisation and sparing of the epigastric vessels and neurovascular bundles. Closure of the posterior rectus sheath with a slowly-absorbable running suture. Indication for a uni- or bilateral TAR identical to the intervention group. Retromuscular synthetic mesh placement with a mesh-size as far as the prepared surface allows. Mesh fixation optional with either absorbable sutures to the posterior sheath or with glubran glue. Closure of the anterior rectus sheath with a slowly-absorbable running suture. Skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.
| Study group | Role | What they receive |
|---|---|---|
| Robotically-assisted ventral hernia repair (RVHR) | Experimental | Not described Receives: Procedure: Robotically-assisted ventral hernia repair (RVHR) |
| Open ventral hernia repair (OVHR) | Active comparator | Not described Receives: Procedure: Open ventral hernia repair (OVHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: length of stay
Length of stay Length of stay is defined as the time from the operation until patient discharge is feasible according to the following criteria:
- pain on numeric rating scale (NRS) < 4 without opioid use
- tolerance of oral food intake without nausea / vomiting
- no signs of surgical site occurrence (SSO) or other postoperative complications
- no drains in place
- autonomy in daily living activities
Measured: 30 days
Secondary outcomes (5)
Comprehensive complication index (CCI)
According to Slankamenac K, Graf R, Barkun J, Clavien P. The Comprehensive Complication Index. Ann Surg. 2013;258 The CCI ranges from 0 (no complications) to maximum 100 (death of the patient).
Measured: 30 days
Adverse events
- Intraoperative adverse events (bleeding, conversion rate, injury to bowel structures)
- Postoperative adverse events (all other than surgical site occurrences such as ileus, pulmonary embolism, pneumonia, etc.) according to Clavien-Dindo Classification up to 30 days after surgery.
Measured: 30 days
pain after surgery
- Pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a after 7days, 30 days, 6 months, 1, 3 and 5 years.
The range fro the PROMIS ranges from 3 (no pain) to maximum of 15 (very severe pain) points.
Measured: 5 years
Functional recovery
Functional recovery measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire.
The questionnaire uses 5 questions describing the patients health and abilities on that particular day and a visual analogue scale question (0 = worst, 100 = best) on the patients health on that particular day.
Measured: 5 years
Quality of life using SF-12 form
The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36).
Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12).
The score ranges from 0 - 100, with a higher score indicating better physical and mental health functioning.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start14 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- St. Clara Hospital, Basel, Switzerland, Klinikum Kempten, Kempten, Germany, Hôpital du Valais
- Responsible party
- Sponsor
- Investigators
- Johannes Baur, MD, Principal investigator, Clarunis - Universitäres Bauchzentrum BaselJulian Süsstrunk, MD, Principal investigator, Clarunis - Universitäres Bauchzentrum Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364306
- Sponsor's protocol ID
- 12032024
- Acronym
- PRIOR
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data (IPD) may be shared upon reasonable request. If IPD is shared, data will be anonymised completely.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06364306
- Acronym / sponsor ID
- PRIOR / 12032024
- Conditions
- Ventral Hernia, Incisional Hernia, Abdominal Wall Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- St. Clara Hospital, Basel, Switzerland, Klinikum Kempten, Kempten, Germany, Hôpital du Valais
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.
The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).
The main questions it aims to answer are:
length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.
Participants will:
Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotically-assisted ventral hernia repair (RVHR) | Experimental | Procedure: Robotically-assisted ventral hernia repair (RVHR) |
| Open ventral hernia repair (OVHR) | Active comparator | Procedure: Open ventral hernia repair (OVHR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age >18 years
- Informed consent obtained
- Transverse diameter of ventral hernia >4cm - 15cm
- Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment
Key exclusion criteria (10 listed)
- precedent hernia treatment with mesh placement in the retromuscular space
- precedent anterior or posterior component separation or transversus abdominis release (TAR)
- active wound infection
- current cancer diagnosis
- presence of ileostomy, colostomy or ileal conduit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotically-assisted ventral hernia repair (RVHR)3 8mm robotic trocars are placed intraabdominally and the DaVinci Xi-robotic system is docked. Adhesiolysis from any adherent structures to the abdominal wall is performed. Incision of the lateral verge of the retromuscular space and retromuscular dissection. Superior and inferior cross-over to the contralateral retromuscular space and dissection of the hernia sac. Unilateral or bilateral transversus abdominis release (TAR) is performed, if necessary. Running suture with absorbable barbed suture of the posterior rectus sheath and peritoneum, as appropriate. Synthetic retromuscular mesh placement with a mesh-size as large as the prepared surface allows. Closure of the anterior rectus sheath with absorbable barbed running suture. Port extraction, skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes. | Procedure or surgery | Robotically-assisted ventral hernia repair (RVHR) |
| Open ventral hernia repair (OVHR)Median laparotomy with a minimal length of the previous scar (in case of incisional hernia) and adhesiolysis is performed, where necessary, to liberate the abdominal wall and the ventral hernia from adhesions. Bilateral dissection of the posterior rectus sheath under visualisation and sparing of the epigastric vessels and neurovascular bundles. Closure of the posterior rectus sheath with a slowly-absorbable running suture. Indication for a uni- or bilateral TAR identical to the intervention group. Retromuscular synthetic mesh placement with a mesh-size as far as the prepared surface allows. Mesh fixation optional with either absorbable sutures to the posterior sheath or with glubran glue. Closure of the anterior rectus sheath with a slowly-absorbable running suture. Skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes. | Procedure or surgery | Open ventral hernia repair (OVHR) |
Primary outcome
Primary outcome: length of stay
Time frame: 30 days
Length of stay Length of stay is defined as the time from the operation until patient discharge is feasible according to the following criteria: * pain on numeric rating scale (NRS) < 4 without opioid use * tolerance of oral food intake without nausea / vomiting * no signs of surgical site occurrence (SSO) or other postoperative complications * no drains in place * autonomy in daily living activities
5 secondary outcomes
Comprehensive complication index (CCI)
Time frame: 30 days
Adverse events
Time frame: 30 days
pain after surgery
Time frame: 5 years
Functional recovery
Time frame: 5 years
Quality of life using SF-12 form
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual patient data (IPD) may be shared upon reasonable request. If IPD is shared, data will be anonymised completely.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Baur, MD principal investigator
Clarunis - Universitäres Bauchzentrum Basel
Julian Süsstrunk, MD principal investigator
Clarunis - Universitäres Bauchzentrum Basel
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotically-assisted ventral hernia repair (RVHR) and Open ventral hernia repair (OVHR) in people with Ventral Hernia and Incisional Hernia, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiorenzo Angehrn, MD (00 41 61 777 73 17, fiorenzo.angehrn@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: length of stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.