Ventral Incisional HerniaROCSTARNCT05575141
Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)
A study testing incisional hernia repair in people with Ventral Incisional Hernia and Abdominal Wall Hernia, run by Algemeen Ziekenhuis Maria Middelares.
Trial summary
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Incisional Hernia, Abdominal Wall Hernia
- What is being tested?
- incisional hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jan 2033
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
Who cannot join
- Pregnant or suspected pregnancy
- Not-curatively treated malignancy, with life expectancy less than 24 months
- Patients unable to give informed consent or complete study specific questionnaires
- Emergency surgery
- Primary ventral hernia repair
- Exclusively lateral hernias not involving the midline
Show all 12Show fewer
- Incisional hernia repair after open abdomen or enterocutaneous fistula
- Active wound infection
- Previous anterior or posterior component separation
- Patients with an existing ostomy
- Patients with a life expectancy of less than 24 months
- Patients suspected of being unable to comply with the study protocol
About this study
Official title: Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.
- Conditions
- Ventral Incisional Hernia, Abdominal Wall Hernia
- Being tested
- incisional hernia repair
- Keywords
- Abdominal Wall Hernia, robotic TAR (rTAR), open TAR (oTAR), transversus abdominis release (TAR)
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incisional hernia repairProcedure or surgery
Incisional hernia repair for the treatment of wide ventral incisional hernias.
| Study group | Role | What they receive |
|---|---|---|
| rTAR | Active comparator | Patients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. Receives: Procedure: incisional hernia repair |
| oTAR | Active comparator | Patients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. Receives: Procedure: incisional hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Length of postoperative hospital stay
Measured: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days
Secondary outcomes (12)
Skin-to-skin operative time
Skin-to-skin operative time from first incision until last skin suture
Measured: Per-operative (minutes)
Conversion rate
Conversion rate from the robotic-assisted approach to the open approach
Measured: Per-operative
Surgical site related complications
Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions
Measured: 30 days
Readmission rate
Readmission rate
Measured: 30 Days and 3 months postoperative
Post-anesthetic discharge scoring system
Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.
Measured: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
Postoperative visual analogue scale pain score
Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.
Measured: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
EuraHS Quality of Life Scoring
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.
Measured: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Body Image Scale
Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
Measured: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Hernia recurrence
Hernia recurrence
Measured: 30 days, 3 Months, 12 months, 24 months, 60 months
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
Measured: 30 days, 3 Months, 12 months, 24 months, 60 months
Postoperative complications
Postoperative complications classified acoording to the Clavien-Dindo Classification
Measured: 30 days
Reoperation rate
Reoperation rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2033 (estimated)
Why it stopped: The study was not initiated and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Incisional HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a multicenter international randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Filip Muysoms, MD PhD, Principal investigator, Clinical research center Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575141
- Sponsor's protocol ID
- ROCSTAR
- Acronym
- ROCSTAR
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05575141
- Acronym / sponsor ID
- ROCSTAR / ROCSTAR
- Conditions
- Ventral Incisional Hernia, Abdominal Wall Hernia
- Keywords
- Abdominal Wall Hernia, robotic TAR (rTAR), open TAR (oTAR), transversus abdominis release (TAR)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 12 Oct 2022 (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.
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a multicenter international randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| rTAR | Active comparator | Procedure: incisional hernia repairPatients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. |
| oTAR | Active comparator | Procedure: incisional hernia repairPatients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
Key exclusion criteria (12 listed)
- Pregnant or suspected pregnancy
- Not-curatively treated malignancy, with life expectancy less than 24 months
- Patients unable to give informed consent or complete study specific questionnaires
- Emergency surgery
- Primary ventral hernia repair
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 |
|---|---|---|
| incisional hernia repairIncisional hernia repair for the treatment of wide ventral incisional hernias. | Procedure or surgery | oTAR, rTAR |
Primary outcome
Length of postoperative hospital stay
Time frame: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days
Length of postoperative hospital stay
12 secondary outcomes
Skin-to-skin operative time
Time frame: Per-operative (minutes)
Conversion rate
Time frame: Per-operative
Surgical site related complications
Time frame: 30 days
Readmission rate
Time frame: 30 Days and 3 months postoperative
Post-anesthetic discharge scoring system
Time frame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
Postoperative visual analogue scale pain score
Time frame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
EuraHS Quality of Life Scoring
Time frame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Body Image Scale
Time frame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Hernia recurrence
Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months
Postoperative complications
Time frame: 30 days
Reoperation rate
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Filip Muysoms, MD PhD principal investigator
Clinical research center Maria Middelares
Questions about this trial
What is this clinical trial studying?
A study testing incisional hernia repair in people with Ventral Incisional Hernia and Abdominal Wall Hernia, run by Algemeen Ziekenhuis Maria Middelares.
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 1 inclusion and 12 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: withdrawn, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of postoperative hospital stay (time frame: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 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 7 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.