Evidence map›Paper›PMID 40037347›Full record

Trial reportBJS open2024

Onlay mesh versus suture repair for smaller umbilical hernias in adults-early results from SUMMER trial: randomized clinical trial.

Mathias Bergström, Björn Widhe, Gabriel Granåsen, Anna Löf Granström, Johan Ohlsson, Simone Schult, Ursula Dahlstrand, Johanna Österberg, Peter Loogna, Sven Bringman and 1 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in BJS open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04231071 nacompletednot on this map

Randomized Double-blind Controlled Multicenter Trial Comparing Suture and Mesh Repair in Small Umbilical Hernias in Adults

TypeinterventionalSponsorKarolinska InstitutetRan2020 to 2024Enrolled288ConditionsUmbilical HerniaArmsOnlay Mesh group
NCT07156188 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial

TypeinterventionalSponsorUniversity of British ColumbiaRan2026 to 2030Enrolled914ConditionsHernia Surgery, Umbilical Hernia RepairArmsPermanent Suture, Absorbable
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mathias BergströmDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Björn WidheDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Gabriel GranåsenDepartment of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Anna Löf GranströmDepartment of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Johan OhlssonDepartment of Clinical Sciences, Danderyds Hospital, Stockholm, Sweden.
Simone SchultDepartment of Surgery, Högsbo Hospital HN, Västra Frölunda, Gothenburg, Sweden.
Ursula DahlstrandDepartment of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0003-3281-0959
Johanna ÖsterbergDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Peter LoognaDepartment of Surgery, Capio Surgery, Stockholm, Sweden.
Sven BringmanDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Maria MelkemichelDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-2161-2888

Funding

Karolinska InstitutetMedical Resident ResearchSödertälje Hospital
6 · The paper itself

Abstract

backgroundMesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet current evidence remains limited for smaller umbilical hernias. Important questions concern optimal mesh positioning and wound complications/surgical-site occurrences. The aim of this study was to report the preliminary results of a trial investigating surgical-site occurrences in suture versus mesh repair for umbilical hernias less than or equal to 2 cm.

methodsA randomized, controlled, parallel-group, double-blind, multicentre trial across six Swedish surgical units is comparing 4 × 4 cm macroporous lightweight onlay mesh repair with conventional suture repair for primary elective umbilical hernias less than or equal to 2 cm. Intraoperative centralized web-based randomization ensured allocation concealment. The primary outcome of the trial is recurrence at 3 years, whereas secondary outcomes (the focus of this study) include surgical-site occurrences and pain intensity at 30 days post-surgery.

resultsFrom February 2020 to January 2024, 290 participants were randomly assigned to either suture or mesh repair. After exclusion and loss to follow-up, the remaining population for analysis was 144 participants for suture repair and 135 participants for mesh repair. Surgical-site occurrences (Clavien-Dindo grade greater than or equal to I) affected 32 mesh repair participants (23.7%) compared with 26 suture repair participants (18.1%), without any significant increase in surgical-site occurrences for mesh repair (OR 1.39 (95% c.i. 0.78 to 2.51)). Clinically relevant surgical-site occurrences (Clavien-Dindo grade greater than or equal to II) were less common in the mesh group (2 participants; 1.5%) compared with the suture group (4 participants; 2.8%). The median duration of surgery was 32 min for suture repair and 45 min for mesh repair (P < 0.001). Assessment of pain intensity revealed that 82.0% of suture repair participants and 73.0% of mesh repair participants reported no pain (P = 0.061).

conclusionThis randomized clinical trial provides high-level evidence for mesh repair for umbilical hernias less than or equal to 2 cm. With regard to early postoperative outcomes, such as surgical-site occurrences, onlay mesh repair can be considered comparable to suture repair and is safe to use for smaller umbilical hernias. REGISTRATION NUMBER: NCT04231071 (http://www.clinicaltrials.gov).

Indexed as

Hernia, UmbilicalHerniorrhaphySurgical MeshSuture TechniquesAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedPostoperative ComplicationsPostoperative PainRecurrenceSwedenTreatment Outcome

Identifiers

PMID40037347
PMCPMC11879325

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.