NIHR DC Discover

NIHR Signal Mesh repair of small umbilical hernias reduces recurrence compared to sutures

Published on 5 June 2018

doi: 10.3310/signal-000600

Repairing small umbilical hernias with surgical mesh rather than sutures reduces the chance of the hernia returning. Complications such as wound infection and pain are not affected by the type of repair.

Adults with umbilical hernias need surgery to prevent serious bowel complications. There are no guidelines about how to best to treat them. In practice, larger hernias tend to be repaired with mesh, while smaller ones are repaired with sutures. This trial of adults with umbilical hernias of 1 to 4cm in diameter is the first good quality evidence to find that mesh repair may be better for smaller umbilical hernias too.

Mesh repairs tend to be longer operations and may bring additional costs. These costs may be balanced by a reduction in the number of people needing further treatment for a recurring hernia. The cost-effectiveness of using mesh still needs to be explored.

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Why was this study needed?

An umbilical hernia appears as a lump in or near the belly button when part of the bowel or fatty material pushes through a weakness between the surrounding muscles. They are very common in infants and children, but can also develop in adults. In England, 21,689 adults had surgery to repair an umbilical hernia in 2016 to 2017.

The hernia can be repaired either with sutures or with mesh. In practice, mesh is more commonly used for bigger hernias (more than 4cm in diameter), and sutures for smaller ones. However, previous studies have suggested that the rate of hernias recurring is higher after suture repair.

This study aimed to investigate whether using mesh instead of sutures for smaller umbilical hernias (measuring 1 to 4cm in diameter) would reduce recurrence.

What did this study do?

This randomised controlled trial involved 12 hospitals in the Netherlands, Germany and Italy. Between June 2006 and April 2014, researchers recruited 300 adults with an umbilical hernia measuring 1 to 4cm. They were assigned to either mesh or suture repair, with 150 in each group.

Patients had physical examinations two weeks after the operation, and then at three, 12, and 24 to 30 months. More than 80% of the participants were male, and the median age was 52 years (range 20-77 years).

At the start of the trial, all the surgeons were invited to training sessions to ensure they used the same standardised techniques. The patients, investigators and analysts were not aware which procedure had been used until after the study finished.

What did it find?

  • At 24 to 30 months after the operation, there were fewer recurrences of a hernia in the mesh group than in the suture group: 6 out of 146 patients in the mesh group (4%) compared to 17 out of 138 patients in the suture group (12%). The researchers calculated that 12.8 people would need to be treated with mesh rather than suture to prevent one recurrent hernia.
  • There was no difference in the number of postoperative wound infections between the groups: 3 out of 146 in the mesh group (2%) compared to 1 out of 138 in the suture group (less than 1%).
  • There was no difference between the groups in the amount of postoperative pain at any time point. Two weeks after the operation, 74% of the suture group and 76% of the mesh group were free from pain. Two years after the operation, 93% of the suture group and 95% of the mesh group were free from pain.
  • Mesh operations took on average 44 minutes while suture operations took on average 33 minutes.

What does current guidance say on this issue?

There is no current guidance as to which technique is recommended. Local NHS patient information leaflets that describe what will happen during an operation to repair an umbilical hernia typically say that either mesh or sutures may be used.

What are the implications?

This is the first large randomised trial of mesh repair for small umbilical hernias of 1 to 4cm diameter. Currently, treatment decisions vary between hospitals and surgeons. This evidence suggests that mesh repair is the best method for repairing umbilical hernias.

It should be noted that operations using mesh generally last longer, and need additional resources. This increase in resources may be balanced by a reduction in recurrence rate and need for repeat operation. No economic evaluation has been carried out.

Citation and Funding

Kaufmann R, Halm JA, Eker HH, et al. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018;391(10123):860-69.

This study was funded by the Department of Surgery of the Erasmus University Medical Centre Rotterdam, Netherlands.

Bibliography

NHS Choices. Umbilical hernia repair. London: Department of Health; updated 2015.

NHS Digital. Hospital admitted patient care activity 2016-17. Leeds: NHS Digital; 2017.

Royal United Hospital Bath NHS Trust. Umbilical or paraumbilical hernia adults. Bath: Royal United Hospital Bath NHS Trust; accessed 23.04.18.

Wrightington, Wigan & Leigh NHS Foundation Trust. Repair of umbilical hernia operation: patient information. Wigan: Wrightington, Wigan & Leigh NHS Foundation Trust; 2016.

Why was this study needed?

An umbilical hernia appears as a lump in or near the belly button when part of the bowel or fatty material pushes through a weakness between the surrounding muscles. They are very common in infants and children, but can also develop in adults. In England, 21,689 adults had surgery to repair an umbilical hernia in 2016 to 2017.

The hernia can be repaired either with sutures or with mesh. In practice, mesh is more commonly used for bigger hernias (more than 4cm in diameter), and sutures for smaller ones. However, previous studies have suggested that the rate of hernias recurring is higher after suture repair.

This study aimed to investigate whether using mesh instead of sutures for smaller umbilical hernias (measuring 1 to 4cm in diameter) would reduce recurrence.

What did this study do?

This randomised controlled trial involved 12 hospitals in the Netherlands, Germany and Italy. Between June 2006 and April 2014, researchers recruited 300 adults with an umbilical hernia measuring 1 to 4cm. They were assigned to either mesh or suture repair, with 150 in each group.

Patients had physical examinations two weeks after the operation, and then at three, 12, and 24 to 30 months. More than 80% of the participants were male, and the median age was 52 years (range 20-77 years).

At the start of the trial, all the surgeons were invited to training sessions to ensure they used the same standardised techniques. The patients, investigators and analysts were not aware which procedure had been used until after the study finished.

What did it find?

  • At 24 to 30 months after the operation, there were fewer recurrences of a hernia in the mesh group than in the suture group: 6 out of 146 patients in the mesh group (4%) compared to 17 out of 138 patients in the suture group (12%). The researchers calculated that 12.8 people would need to be treated with mesh rather than suture to prevent one recurrent hernia.
  • There was no difference in the number of postoperative wound infections between the groups: 3 out of 146 in the mesh group (2%) compared to 1 out of 138 in the suture group (less than 1%).
  • There was no difference between the groups in the amount of postoperative pain at any time point. Two weeks after the operation, 74% of the suture group and 76% of the mesh group were free from pain. Two years after the operation, 93% of the suture group and 95% of the mesh group were free from pain.
  • Mesh operations took on average 44 minutes while suture operations took on average 33 minutes.

What does current guidance say on this issue?

There is no current guidance as to which technique is recommended. Local NHS patient information leaflets that describe what will happen during an operation to repair an umbilical hernia typically say that either mesh or sutures may be used.

What are the implications?

This is the first large randomised trial of mesh repair for small umbilical hernias of 1 to 4cm diameter. Currently, treatment decisions vary between hospitals and surgeons. This evidence suggests that mesh repair is the best method for repairing umbilical hernias.

It should be noted that operations using mesh generally last longer, and need additional resources. This increase in resources may be balanced by a reduction in recurrence rate and need for repeat operation. No economic evaluation has been carried out.

Citation and Funding

Kaufmann R, Halm JA, Eker HH, et al. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018;391(10123):860-69.

This study was funded by the Department of Surgery of the Erasmus University Medical Centre Rotterdam, Netherlands.

Bibliography

NHS Choices. Umbilical hernia repair. London: Department of Health; updated 2015.

NHS Digital. Hospital admitted patient care activity 2016-17. Leeds: NHS Digital; 2017.

Royal United Hospital Bath NHS Trust. Umbilical or paraumbilical hernia adults. Bath: Royal United Hospital Bath NHS Trust; accessed 23.04.18.

Wrightington, Wigan & Leigh NHS Foundation Trust. Repair of umbilical hernia operation: patient information. Wigan: Wrightington, Wigan & Leigh NHS Foundation Trust; 2016.

Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial

Published on 21 February 2018

Kaufmann, R.,Halm, J. A.,Eker, H. H.,Klitsie, P. J.,Nieuwenhuizen, J.,van Geldere, D.,Simons, M. P.,van der Harst, E.,van 't Riet, M.,van der Holt, B.,Kleinrensink, G. J.,Jeekel, J.,Lange, J. F.

Lancet , 2018

BACKGROUND: Both mesh and suture repair are used for the treatment of umbilical hernias, but for smaller umbilical hernias (diameter 1-4 cm) there is little evidence whether mesh repair would be beneficial. In this study we aimed to investigate whether use of a mesh was better in reducing recurrence compared with suture repair for smaller umbilical hernias. METHODS: We did a randomised, double-blind, controlled multicentre trial in 12 hospitals (nine in the Netherlands, two in Germany, and one in Italy). Eligible participants were adults aged at least 18 years with a primary umbilical hernia of diameter 1-4 cm, and were randomly assigned (1:1) intraoperatively to either suture repair or mesh repair. In the first 3 years of the inclusion period, blocked randomisation (of non-specified size) was achieved by an envelope randomisation system; after this time computer-generated randomisation was introduced. Patients, investigators, and analysts were masked to the allocated treatment, and participants were stratified by hernia size (1-2 cm and >2-4 cm). At study initiation, all surgeons were invited to training sessions to ensure they used the same standardised techniques for suture repair or mesh repair. Patients underwent physical examinations at 2 weeks, and 3, 12, and 24-30 months after the operation. The primary outcome was the rate of recurrences of the umbilical hernia after 24 months assessed in the modified intention-to-treat population by physical examination and, in case of any doubt, abdominal ultrasound. This trial is registered with ClinicalTrials.gov, number NCT00789230. FINDINGS: Between June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25.1 months (IQR 15.5-33.4). After a maximum follow-up of 30 months, there were fewer recurrences in the mesh group than in the suture group (six [4%] in 146 patients vs 17 [12%] in 138 patients; 2-year actuarial estimates of recurrence 3.6% [95% CI 1.4-9.4] vs 11.4% (6.8-18.9); p=0.01, hazard ratio 0.31, 95% CI 0.12-0.80, corresponding to a number needed to treat of 12.8). The most common postoperative complications were seroma (one [<1%] in the suture group vs five [3%] in the mesh group), haematoma (two [1%] vs three [2%]), and wound infection (one [<1%] vs three [2%]). There were no anaesthetic complications or postoperative deaths. INTERPRETATION: This is the first study showing high level evidence for mesh repair in patients with small hernias of diameter 1-4 cm. Hence we suggest mesh repair should be used for operations on all patients with an umbilical hernia of this size. FUNDING: Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.

Expert commentary

The decision of whether to use mesh for the repair of small umbilical hernias has been an on-going surgical dilemma. Most surgeons decide intraoperatively; performing suture repairs for small defects and reserving the use of mesh for larger defects (individual surgeons’ thresholds vary). This the first large trial looking at sutures versus mesh for the repair of small umbilical defects.

In this study, even in the 1 to 2cm defect group the recurrence rates at two years were significantly higher in the suture group (8% vs 2%). Interestingly there was no difference in complications including infection or pain between the groups, which are often the reasons for surgeons’ reluctance to use mesh.

The study does not address the question of what to do with defects 1cm or less but does allow a more informed discussion with patients about the risks and benefits of mesh and suture repair.

David L Sanders, Consultant Upper GI & Abdominal Wall Surgeon, North Devon District Hospital & Scientific Secretary British Hernia Society

Expert commentary

Umbilical hernias are common, and most are 1 to 4cm in size. It is broadly accepted that larger hernias require mesh for support, but it is not so clear for the more common smaller types. To insert a mesh makes the operation slightly more difficult and could potentially cause harm.

Good quality data to justify mesh use in these patients is therefore required. This very well designed study is convincing evidence that routine use of mesh in all sizes of an umbilical hernia will reduce recurrence while not causing additional complications and is worth the extra effort by the surgeon.

Steven Brown, Consultant General Surgeon, Sheffield Teaching Hospitals