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NCT04231071: SUMMER
Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial
NA trial testing Onlay Mesh group in Umbilical Hernia in 288 participants. Completed in 3 January 2024.
3 January 2024
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 288 |
| Start date | 3 February 2020 |
| Primary completion | 3 January 2024 |
| Estimated completion | 3 January 2024 |
| Sites | 7 locations across Sweden |
Drugs / interventions tested
- Onlay Mesh group
Conditions studied
- Umbilical Hernia — all drugs for Umbilical Hernia →
Sponsor
Karolinska Institutet
Who can join
18 and older, any sex, with Umbilical Hernia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Umbilical hernia repair is one of the most common surgical performance in general surgery. Up to now, the use of suture repair has been the preferred technique for small umbilical hernia defects without any gold standard procedure. Mesh have been reserved to larger umbilical hernia defects. However, there is an increasing evidence that mesh reinforcement could be advantageous to lower the high recurrence rates also in smaller umbilical hernias. A remained important question is in what anatomical position the mesh should be placed. The investigators hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduces recurrence rates without increasing postoperative complications compared to a suture repair.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults-a study protocol for a prospective randomized double-blind multicenter clinical trial.
Melkemichel M, Bringman S, Granåsen G, Widhe B. · · 2021 · cited 4× · PMID 34158088 · DOI 10.1186/s13063-021-05366-7 -
Onlay mesh versus suture repair for smaller umbilical hernias in adults-early results from SUMMER trial: randomized clinical trial.
Bergström M, Widhe B, Granåsen G, Löf Granström A, et al · · 2024 · cited 1× · PMID 40037347 · DOI 10.1093/bjsopen/zrae173 -
SUMMER Trial: Mesh Versus Suture Repair in Small Umbilical Hernias in Adults: a Study Protocol for a Prospective Randomized Double-blind Multicenter Clinical Trial
Melkemichel M, Bringman S, Granåsen G, Widhe B. · · 2021 · DOI 10.21203/rs.3.rs-475715/v1
Verify or expand the search:
- PubMed search for NCT04231071
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Umbilical Hernia
Currently open trials in the same condition.
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- NCT06783036 — Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair · active not recruiting
- NCT05920200 — Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations · recruiting
Other Karolinska Institutet trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04231071 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 6 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231071.
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