PainROHYBNCT05233020
Robotic Versus Hybrid Assisted Ventral Hernia Repair
A study testing robotic and hybrid in people with Pain and Quality of Life, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Quality of Life, Recurrence
- What is being tested?
- robotic and hybrid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 28 Sep 2021to 30 Nov 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ventral hernia size 3-6 cm
Who cannot join
- previous ventral hernia
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70200
Pirjo Käkelä, PhD, 044 717 4796, pirjo.kakela@kuh.fi
Kirsi Mustonen, MD, 044 717 5732, kirsi.m.mustonen@kuh.fi
About this study
Official title: Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).
Read the detailed description
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.
- Conditions
- Pain, Quality of Life, Recurrence
- Being tested
- robotic, hybrid
- Keywords
- Ventral hernia, Laparoscopy, Robot-assisted, pain
- Medical subject headings
- Pain, Recurrence, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roboticDevice
fifteen patients undergo robotic operation
hybridDevice
fifteen patients undergo hybrid operation
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | Fifteen patients undergo rVHR operation. Receives: Device: robotic |
| hybrid | Experimental | Fifteen patients undergo hybrid operation. Receives: Device: hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Robotic-assisted ventral hernia repair vs hybrid. Change in pain
VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain
Measured: 1-year
Secondary outcomes (1)
Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.
SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start28 Sep 2021
- Primary completionNov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kakela Pirjo, Kuopio University Hospital
- Investigators
- Pirjo Käkelä, PhD, Study director, gi -surgeon, clinical teacherPirjo Käkelä, PhD, Principal investigator, gi-surgeon, clinical teacher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233020
- Sponsor's protocol ID
- 5200662
- Acronym
- ROHYB
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT05233020
- Acronym / sponsor ID
- ROHYB / 5200662
- Conditions
- Pain, Quality of Life, Recurrence
- Keywords
- Ventral hernia, Laparoscopy, Robot-assisted, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Feb 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.
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).
Detailed description
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Device: roboticFifteen patients undergo rVHR operation. |
| hybrid | Experimental | Device: hybridFifteen patients undergo hybrid operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ventral hernia size 3-6 cm
Key exclusion criteria (1 listed)
- previous ventral hernia
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 |
|---|---|---|
| roboticfifteen patients undergo robotic operation | Device | Robotic |
| hybridfifteen patients undergo hybrid operation | Device | hybrid |
Primary outcome
Robotic-assisted ventral hernia repair vs hybrid. Change in pain
Time frame: 1-year
VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain
1 secondary outcome
Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- 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.
Pirjo Käkelä, PhD study director
gi -surgeon, clinical teacher
Pirjo Käkelä, PhD principal investigator
gi-surgeon, clinical teacher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic and hybrid in people with Pain and Quality of Life, run by Kuopio University Hospital at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pirjo Käkelä, PhD (044 717 4796, pirjo.kakela@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Robotic-assisted ventral hernia repair vs hybrid. Change in pain (time frame: 1-year). 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 10 Feb 2022.