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Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial
- Source :
- 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 2018, ' Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial ', The Lancet, vol. 391, no. 10123, pp. 860-869 . https://doi.org/10.1016/S0140-6736(18)30298-8, Lancet (UK), 391(10123), 860-869. Elsevier Ltd., Lancet, 391(10123), 860-869. Elsevier Limited, The Lancet, 391(10123), 860-869. Elsevier Limited
- Publication Year :
- 2018
-
Abstract
- 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 [
- Subjects :
- Adult
Male
medicine.medical_specialty
Population
030230 surgery
law.invention
03 medical and health sciences
0302 clinical medicine
Postoperative Complications
Suture (anatomy)
Randomized controlled trial
Double-Blind Method
law
Recurrence
Germany
Outcome Assessment, Health Care
Medicine
Humans
Hernia
education
Aged
Netherlands
education.field_of_study
Sutures
business.industry
Suture Techniques
General Medicine
Middle Aged
Surgical Mesh
medicine.disease
Surgery
Umbilical hernia
Surgical mesh
Italy
030220 oncology & carcinogenesis
Seroma
Number needed to treat
Quality of Life
Female
business
Hernia, Umbilical
Subjects
Details
- Language :
- English
- ISSN :
- 01406736
- Volume :
- 391
- Issue :
- 10123
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....1761c62f7b6e7be025ba06947b5be99c