ClinicalTrials.gg
Not yet recruitingNCT07925112ROARUpdated Nov 9, 2026

Robotic vs Open Retromuscular Abdominal Wall Hernia Repair

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

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
132
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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

  • early patient reported pain and function after robotic and open retromuscular repair of ventral hernia,
  • surgeon perception of procedural workload,
  • patient perceptions of surgery and recovery
  • metrics of abdominal wall functional recovery

Objectives:

  1. Primary outcome: compare ventral hernia-specific quality of life at 2 weeks after surgery
  2. Compare other aspects of recovery: ventral hernia repair-specific quality of life at other timepoints (up to 12 weeks), pain and physical function (symptoms and physical tests)
  3. Compare surgical complications (30 days and 3 months) and length of hospital stay
  4. Explore differences in resource utilisation and financial costs
  5. Explore surgeon perspectives of operations, using a validated measure of surgical workload
  6. Explore patient perspectives and experiences of recovery
  7. Explore physical metrics of abdominal wall function in a subset of patients

132 (n=66 open, n=66 robotic)

  • Adult patients (>18)
  • undergoing elective retromuscular repair of a ventral abdominal wall hernia via either an open or robotic approach
  • with a hernia in principle amenable to either robotic or open repair in one centre (defect width 2-10cm as evidenced on most recent pre-operative cross sectional imaging)

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.

02

Conditions studied

  • Ventral Hernia Repair
  • Ventral Hernia
  • Robotic Surgery
  • Abdominal Wall Hernia

Keywords

  • hernia; ventral hernia; incisional hernia; umbilical hernia; epigastric hernia; robotic surgery; open surgery
03

In context

Hernia, Ventral

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

•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.

Inclusion criteria

  • Able to understand the study information and willing to give
  • In the opinion of the listing surgeon, able to provide written informed consent for the operation
  • Age 18 or older
  • Undergoing elective RM VHR, defined as3, 5:

    • a non-emergency operation (i.e. one with a planned admission date in the future for surgery, including expedited and urgent surgery) to repair,
    • a ventral hernia (a protrusion of an abdominal viscus/viscera through a defect in the anterior and/or lateral abdominal wall, based on the European Hernia Society Classification of abdominal wall hernias14; this includes hernias located in the midline (M1-M5) and lateral (L1-L4) aspects of the abdominal wall, with or without a concomitant groin hernia
    • using a mesh/implant reconstruction placed directly behind the muscles of the abdominal wall (as distinct from pre-peritoneal), as defined by the International Classification of abdominal wall planes for VHR15
  • planned either by a direct incision (open surgery) or a robotically assisted minimally invasive approach using a Da Vinci Platform (Intuitive Surgical, CA, USA).
  • A hernia realistically repairable in principle by at least one study centre by either robotic or an open approach (defined as a main hernia defect width between 2 and 10cm based on the most recent cross-sectional imaging)

Exclusion criteria

Exclusion Criteria:

  • Unwilling or unable to understand the study information and give consent

    • In the opinion of the listing surgeon, unable to provide written for the operation
    • Inability to understand written and / or verbal English
    • Age \<18
    • Isolated or concomitant parastomal hernia
    • Planned concomitant bowel resection
    • Presence of a concomitant enterocutaneous fistula
    • Presence of suspected mesh infection or erosion (into bowel or through skin)
    • Suspected risk of loss of domain (as defined by the International Consensus on Loss of Domain)16
    • Operation performed for a main hernia defect smaller than 2cm or larger than 10cm, as evidenced by most recent cross-sectional imaging
    • Operation performed by a non-da Vinci robot platform
    • Emergency surgery, defined as operation performed for current bowel obstruction/strangulation/acute incarceration
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
132 participants (estimated)
Patient registry
No

Groups and cohorts

  • Robotic retromuscular ventral hernia repair

    Participants undergoing planned robotically-assisted ventral hernia repair using a retromuscular mesh implant

  • Open retromuscular ventral hernia repair

    Participants undergoing planned open ventral hernia repair using a retromuscular mesh implant

06

What researchers measure

Primary outcomes

  1. HerQLes instrument

    Ventral hernia specific quality of life

    Time frame: 2 weeks after surgery

Secondary outcomes

  1. HerQLEs instument

    Ventral hernia specific quality of life

    Time frame: At other timepoints up to 12 weeks after surgery

  2. Surgical complications

    Surgical complications

    Time frame: 30 days and 12 weeks

  3. SURG-TLX

    Surgeon workload

    Time frame: At surgery

  4. Pain intensity (NRS)

    Pain intensity (NRS) over preceeding week

    Time frame: Throughout study (0,2,4,6,12 weeks)

  5. PROMS-PF SF 4a

    Physical function PROM

    Time frame: Throughout study (0,2,4,6,12 weeks)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07925112
Lead sponsor
Royal Devon and Exeter NHS Foundation Trust
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

John Findlay
Contact
j.m.findlay@exeter.ac.uk
+44(0)1392403431
John Findlay
principal investigator · University of Exeter

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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