An observational study in Ventral Hernia Repair, Ventral Hernia and Robotic Surgery, sponsored by Royal Devon and Exeter NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Observational
A hernia is a bulge through a hole in the muscles of the belly (abdomen) wall. A hernia at the front of the abdomen ('ventral' part) is called a ventral hernia. These happen in a weak area; either on its own or caused by an operation. These can cause pain, get in the way of things people want to do, be upsetting because of how they look, and sometimes can get stuck out (which can cause blockage of the bowels). These can make people's quality of life worse. Because of this, ventral hernias are often repaired in a planned way with an operation.
Expert groups have looked at the evidence from studies, and recommend that the best way to repair all but the smallest ventral hernias is by closing the weakness and reinforcing this and the area around it with an implant. This is called a mesh, and is normally made of plastic. Normally this mesh is placed directly behind the muscles, rather than on top of them. This is called a retromuscular ventral hernia repair.
This used to always be done through the skin over the hernia. This is called an open repair. More recently, it has become possible to do the same operation keyhole, using a surgical robot. This is called a robotic repair. Surgeons think that the end result is the same. But we do not know if how the operation is done affects patients' recovery and experience in the weeks and first few months after surgery.
The aim of this study is to see if people recover differently depending on whether their operation is done open or with a robot. To answer this question, we will run this study in a number of specialist hernia hospitals in the UK. We will ask people who have already decided to have this operation if they would like to take part. We are aiming for 132 people to sign up. They are free to say yes or no, and whatever they say we will not change what operation they have, when or where they have it, and which surgeon does it.
We will collect some information about their hernia and operation when they have surgery.
Then we will contact them in the weeks after their operation, to collect information about their recovery and quality of life. To compare people having robotic and open surgery, in our analysis we will use the information about them and their operation to 'match' them with the person who is most similar in the other group.
We will ask everyone if they want to take part in two extra parts of the study as well. Again, they are free to say yes or no to these as well. The first involves talking to people about their experiences of recovery, so we can understand these better. We can do this in person, on the phone or online depending on what suits them.
The second involves some people coming to our sports science laboratory in Exeter. In this laboratory we will use some simple tests to measure what they can do with their abdomen (such as movement). We see if people can perform these tests, and perhaps see if there is a difference between the operations.
A multi-centre, prospective observational cohort study, conducted in five specialist and established sites) performing robotic or open retromuscular ventral hernia repair.
Aims: to compare
Objectives:
132 (n=66 open, n=66 robotic)
Clinical study:
A propensity-matched multilevel model will assess significance of a treatment effect in the primary outcome measure, ventral hernia-specific quality of life (HerQLes), with a target mean difference corresponding to the defined minimum clinically important difference (MCID) of this instrument. Exploratory (unpowered) analyses will be undertaken for secondary outcomes.
Qualitative study
An embedded qualitative sub-study will explore patients' lived experiences of recovery and function following the two surgical approaches. Up to 20 semi-structured interviews will be conducted 6-12 weeks postoperatively and thematically analysed to gain in depth insight into postoperative complications, pain, physical activity, well-being, return to work and social life and cosmetic satisfaction.
Functional study
An embedded functional sub-study will be conducted in up to 20 patients, before and after surgery. A predefined set of laboratory measurements will be undertaken before and at least 6 weeks after surgery. Both will be repeated to by the same assessor. Intra-observer reliability, and participant acceptability will be assessed. Exploratory (unpowered) analyses will be performed with these and relevant clinical data and outcomes.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 132 is close to the median of 132 across 65 observational studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
•Our target population is adult patients undergoing elective RM VHR via either open or robotic approach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Undergoing elective RM VHR, defined as3, 5:
Exclusion Criteria:
Unwilling or unable to understand the study information and give consent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing planned robotically-assisted ventral hernia repair using a retromuscular mesh implant
Participants undergoing planned open ventral hernia repair using a retromuscular mesh implant
HerQLes instrument
Ventral hernia specific quality of life
Time frame: 2 weeks after surgery
HerQLEs instument
Ventral hernia specific quality of life
Time frame: At other timepoints up to 12 weeks after surgery
Surgical complications
Surgical complications
Time frame: 30 days and 12 weeks
SURG-TLX
Surgeon workload
Time frame: At surgery
Pain intensity (NRS)
Pain intensity (NRS) over preceeding week
Time frame: Throughout study (0,2,4,6,12 weeks)
PROMS-PF SF 4a
Physical function PROM
Time frame: Throughout study (0,2,4,6,12 weeks)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Royal Devon and Exeter NHS Foundation Trust