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Cited by 78Hernia repair and managementAbdominal Surgery and ComplicationsStoma care and complications

The DOI matches its Crossref record; 36 of the 36 references it cites were found in a registry or an index; none of the 28 sources its claims cite is checked for support yet.

Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial

Open access

Abstract

Importance: Although multiple versions of polypropylene mesh devices are currently available on the market for hernia repair, few comparisons exist to guide surgeons as to which device may be preferable for certain indications. Mesh density is believed to impact patient outcomes, including rates of chronic pain and perception of mesh in the abdominal wall. Objective: To examine whether medium-weight polypropylene is associated with less pain at 1 year compared with heavy-weight mesh. Design, Setting, and Participants: This multicenter randomized clinical trial was performed from March 14, 2017, to April 17, 2019, with 1-year follow-up. Patients undergoing clean, open ventral hernia repairs with a width 20 cm or less were studied. Patients were blinded to the intervention. Interventions: Patients were randomized to receive medium-weight or heavy-weight polypropylene mesh during open ventral hernia repair. Main Outcomes and Measures: The primary outcome was pain measured with the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a. Secondary outcomes included quality of life and pain measured at 30 days, quality of life measured at 1 year, 30-day postoperative morbidity, and 1-year hernia recurrence. Results: A total of 350 patients participated in the study, with 173 randomized to receive heavy-weight polypropylene mesh (84 [48.6%] female; mean [SD] age, 59.2 [11.4] years) and 177 randomized to receive medium-weight polypropylene mesh (91 [51.4%] female; mean [SD] age, 59.3 [11.4] years). No significant differences were found in demographic characteristics (mean [SD] body mass index of 32.0 [5.4] in both groups [calculated as weight in kilograms divided by height in meters squared] and American Society of Anesthesiologists classes of 2-4 in both groups), comorbidities (122 [70.5%] vs 93 [52.5%] with hypertension, 44 [25.4%] vs 43 [24.3%] with diabetes, 17 [9.8%] vs 12 [6.8%] with chronic obstructive pulmonary disease), or operative characteristics (modified hernia grade of 2 in 130 [75.1] vs 140 [79.1] in the heavy-weight vs medium-weight mesh groups). Pain scores for patients in the heavy-weight vs medium-weight mesh groups at 30 days (46.3 vs 46.3, P = .89) and 1 year (30.7 vs 30.7, P = .59) were identical. No significant differences in quality of life (median [interquartile range] hernia-specific quality of life score at 1 year of 90.0 [67.9-96.7] vs 86.7 [65.0-93.3]; median [interquartile range] hernia-specific quality of life score at 30 days, 45.0 [24.6-73.8] vs 43.3 [28.3-65.0]) were found for the heavy-weight mesh vs medium-weight mesh groups. Composite 1-year recurrence rates for patients in the heavy-weight vs medium-weight polypropylene groups were similar (8% vs 7%, P = .79). Conclusions and Relevance: Medium-weight polypropylene did not demonstrate any patient-perceived or clinical benefit over heavy-weight polypropylene after open retromuscular ventral hernia repair. Long-term follow-up of these comparable groups will elucidate any potential differences in durability that have yet to be identified. Trial Registration: ClinicalTrials.gov Identifier: NCT03082391.

Overview

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TL;DR

In this multicenter randomized clinical trial of 350 patients undergoing open retromuscular ventral hernia repair, medium-weight polypropylene mesh did not improve pain, quality of life, mesh sensation, or recurrence compared with heavy-weight mesh at 1 year. The authors conclude medium-weight mesh showed no patient-perceived or clinical benefit over heavy-weight mesh in this setting.

Key findings

  • Primary outcome: NIH PROMIS Pain Intensity Short Form 3a scores were identical between heavy-weight and medium-weight mesh at 30 days (46.3 vs 46.3; P = .89) and 1 year (30.7 vs 30.7; P = .59).
  • Hernia-specific quality of life (HerQLes) at 1 year was similar: median 90.0 (IQR, 67.9-96.7) for heavy-weight vs 86.7 (IQR, 65.0-93.3) for medium-weight (P = .41).
  • Composite 1-year hernia recurrence was similar: 8% heavy-weight vs 7% medium-weight (P = .79). Mesh sensation (“Do you feel your mesh?”) was reported by 33 (19.1%) vs 32 (18.1%) patients (P = .93).
  • Thirty-day outcomes were comparable, including surgical site infection (4.8% vs 5.5%) and surgical site occurrence (12.0% vs 9.9%).

Methods

  • Multicenter randomized clinical trial conducted March 14, 2017, to April 17, 2019, with 1-year follow-up; 10 surgeons at 4 institutions enrolled 350 patients undergoing elective, open, clean, retromuscular ventral hernia repair with hernia width ≤20 cm and primary fascial closure.
  • Patients were randomized 1:1 to medium-weight (40-60 g/m²) or heavy-weight (>75 g/m²) polypropylene mesh via central concealed REDCap randomization; patients were blinded to mesh weight.
  • Primary outcome was 1-year pain by NIH PROMIS Pain Intensity Short Form 3a; secondary outcomes included 30-day morbidity, 1-year hernia recurrence, and HerQLes quality of life. Analysis was intent-to-treat using nonparametric tests, regression models, and bootstrap CIs.

Limitations

  • The authors state the findings apply only to flat sheet polypropylene placed in a retromuscular position and are not generalizable to intraperitoneal mesh placement; mesh weight varied within each category because products were not standardized across sites.
  • The authors note the trial focused on patient-reported outcomes and temporarily ignored hernia recurrence, did not evaluate chronic pain syndromes, and planned long-term follow-up to assess durability.
  • Evident from the text: 16 patients per group were lost to follow-up (10% heavy-weight, 9% medium-weight), and recurrence assessment was challenging, with disagreement among blinded CT assessors and differing recurrence rates by detection method (e.g., HRI 30.1% vs 35.0%; physical examination 1.2% vs 2.3%; CT 1.7% vs 1.7%).

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Integrity signals

Registry

Crossref · 10.1001/jamasurg.2021.4309

Cites

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Metadata

Authors
Krpata, D. M., Petro, C. C., Prabhu, A. S., Tastaldi, L., Zolin, S., Fafaj, A., Rosenblatt, S., Poulose, B. K., Pierce, R. A., Warren, J. A., Carbonell, A. M., Goldblatt, M. I., Stewart, T. G., Olson, M. A., & Rosen, M. J.
Affiliations
  • Cleveland Clinic (US)
  • Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, Ohio
  • The Ohio State University Wexner Medical Center (US)
  • Vanderbilt University (US)
  • Prisma Health (US)
  • Medical College of Wisconsin (US)
  • Weill Cornell Medicine (US)
Corresponding author
Krpata, David M.
Venue
JAMA Surgery
Published
2021-12-01
Volume
156
Issue
12
Pages
1085
ISSN
2168-6254 (ISSN-L)
OpenAlex
W3201555788
Cited by
78
References
36
Citations by year
2026: 19 · 2025: 22 · 2024: 11 · 2023: 18 · 2022: 5 · 2021: 2
FWCI
8.11
Type
journal article
Language
en
Open access
Locations
  • JAMA Surgery (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Hernia repair and management
  • Health Sciences › Medicine › Surgery › Abdominal Surgery and Complications
  • Health Sciences › Medicine › Surgery › Stoma care and complications
Keywords
ventral hernia repair, polypropylene mesh, mesh weight, mesh density, chronic pain, postoperative pain, quality of life, hernia recurrence, postoperative morbidity
MeSH terms
Patient Reported Outcome Measures, Female, Hernia, Ventral, Humans, Male, Middle Aged, Pain Measurement, Postoperative Pain, Polypropylenes, Prosthesis Design, Surgical Mesh

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