Evidence map›Paper›PMID 30627841›Full record

Trial reportSurgical endoscopy2019

An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair.

Merritt Denham, Brandon Johnson, Michelle Leong, Kristine Kuchta, Eliza Conaty, Michael B Ujiki, Woody Denham, Stephen P Haggerty, Zeeshan Butt, JoAnn Carbray and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

12 authors.

Merritt DenhamSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Brandon JohnsonSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Michelle LeongSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Kristine KuchtaSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Eliza ConatySection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Michael B UjikiSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Woody DenhamSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Stephen P HaggertySection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Zeeshan ButtNorthwestern University Feinberg School of Medicine, Evanston, IL, 60201, USA.
JoAnn CarbraySection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
Matt GitelisSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA.
John G LinnSection of Minimally Invasive Surgery, Department of Surgery, NorthShore Center for Simulation and Innovation, NorthShore University HealthSystem, 2650 Ridge Ave, Evanston, IL, 60201, USA. jlinn@northshore.org.ORCID 0000-0003-1222-3570

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh.

methodsAn IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3 weeks and 1 year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients' QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1 year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests.

resultsTwo hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6 years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0 months, p = 0.846). Median operative times (34 vs 34 min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3 days following surgery (Day 1: p = 0.005; Day 2: p = 0.002; Day 3: p = 0.024, Table 1) indicating less pain. No differences in pain were seen 3 weeks or 1 year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups.

conclusionsPatients receiving self-fixating mesh report worse postoperative pain in the first 2-3 days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.

Indexed as

Surgical MeshAdultAgedFemaleFollow-Up StudiesHernia, InguinalHerniorrhaphyHumansLaparoscopyMaleMiddle AgedOperative TimePatient Outcome AssessmentPostoperative PainProspective StudiesQuality of LifeChronic painInguinal herniaLaparoscopyQuality of lifeSelf-fixating mesh

Identifiers

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Registered trials

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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.