Evidence map›Paper›PMID 28009747›Full record

Observational studyAnnals of surgery2017

Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study.

Michael J Rosen, Joel J Bauer, Marco Harmaty, Alfredo M Carbonell, William S Cobb, Brent Matthews, Matthew I Goldblatt, Don J Selzer, Benjamin K Poulose, Bibi M E Hansson and 3 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Annals of surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06197854 (Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia), which is not on this map. Cited by 125 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 7 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.

NCT06197854 unknown statusnot on this mapstarted 2024, after this paper: background citation

Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia

TypeobservationalSponsorAssiut UniversityRan2024 to 2025Enrolled40ConditionsIncisional HerniaArmsHernioplasty
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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65 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Michael J Rosen*Department of General Surgery, Cleveland Clinic Foundation, Cleveland, OH †Department of Surgery, Mount Sinai School of Medicine, New York, NY ‡Division of Minimal Access and Bariatric Surgery, Greenville Health System, Greenville, SC §Department of Surgery, Carolinas Medical Center, Charlotte, NC ¶Department of Surgery, Medical College of Wisconsin, Milwaukee, WI ||Department of Surgery, Indiana University School of Medicine, Indianapolis, IN **Division of General Surgery, Vanderbilt University Medical Center, Nashville, TN ††Department of Surgery, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands ‡‡Oasis MD Lifestyle Healthcare, San Diego, CA §§Department of Surgery, University California, San Diego School of Medicine, San Diego, CA.
Joel J Bauer
Marco Harmaty
Alfredo M Carbonell
William S Cobb
Brent Matthews
Matthew I Goldblatt
Don J Selzer
Benjamin K Poulose
Bibi M E Hansson
Camiel Rosman
James J Chao
Garth R Jacobsen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months.

backgroundCVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates.

methodsPatients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests.

resultsPatients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05).

conclusionsIn this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Indexed as

Absorbable ImplantsQuality of LifeSurgical MeshAdultAgedAged, 80 and overFemaleHealth Status IndicatorsHernia, VentralHerniorrhaphyHumansKaplan-Meier EstimateLongitudinal StudiesMaleMiddle AgedProspective Studies

Identifiers

PMID28009747
PMCPMC5181129

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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.