A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery

Bilezikian, Jordan A; Tenzel, Paul; Johnson, Robert G.; Powers, William F.; Hope, William W.

doi:10.1007/s00464-020-07512-9

Cited by 5 publications

(4 citation statements)

References 15 publications

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“…Partially clustered trials with cluster randomisation of pre-existing clusters have been reported in fields including pregnancy and neonatal health, 43–49 sports medicine, 50 ophthalmology 51 and surgery. 52…”

Section: Methods and Examplesmentioning

confidence: 99%

“…Partially clustered trials with cluster randomisation of pre-existing clusters have been reported in fields including pregnancy and neonatal health, [43][44][45][46][47][48][49] sports medicine, 50 ophthalmology 51 and surgery. 52 Example trial. A surgical trial compared two mesh prosthetics placed during minimally invasive inguinal hernia repair.…”

Section: Individualmentioning

confidence: 99%

“…A surgical trial compared two mesh prosthetics placed during minimally invasive inguinal hernia repair. 52 Patients were randomised to surgery with either a flat lightweight polypropylene mesh or a preformed lightweight mesh. Patients with both unilateral and bilateral inguinal hernias were eligible, and patients with bilateral hernias received the same mesh treatment for both procedures, resulting in a partially clustered trial with cluster randomisation of pre-existing clusters (patients).…”

Section: Individualmentioning

confidence: 99%

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Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology

et al. 2023

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Introduction: Clinical trial designs based on the assumption of independent observations are well established. Clustered clinical trial designs, where all observational units belong to a cluster and outcomes within clusters are expected to be correlated, have also received considerable attention. However, many clinical trials involve partially clustered data, where only some observational units belong to a cluster. Examples of such trials occur in neonatology, where participants include infants from both singleton and multiple births, and ophthalmology, where one or two eyes per participant may need treatment. Partial clustering can also arise in trials of group-based treatments (e.g. group education or counselling sessions) or treatments administered individually by a discrete number of health care professionals (e.g. surgeons or physical therapists), when this is compared to an unclustered control arm. Trials involving partially clustered data have received limited attention in the literature and the current lack of standardised terminology may be hampering the development and dissemination of methods for designing and analysing these trials. Methods and examples: In this article, we present an overarching definition of partially clustered trials, bringing together several existing trial designs including those for group-based treatments, clustering due to facilitator effects and the re-randomisation design. We define and describe four types of partially clustered trial designs, characterised by whether the clustering occurs pre-randomisation or post-randomisation and, in the case of pre-randomisation clustering, by the method of randomisation that is used for the clustered observations (individual randomisation, cluster randomisation or balanced randomisation within clusters). Real life examples are provided to highlight the occurrence of partially clustered trials across a variety of fields. To assess how partially clustered trials are currently reported, we review published reports of partially clustered trials. Discussion: Our findings demonstrate that the description of these trials is often incomplete and the terminology used to describe the trial designs is inconsistent, restricting the ability to identify these trials in the literature. By adopting the definitions and terminology presented in this article, the reporting of partially clustered trials can be substantially improved, and we present several recommendations for reporting these trial designs in practice. Greater awareness of partially clustered trials will facilitate more methodological research into their design and analysis, ultimately improving the quality of these trials.

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Section: Methods and Examplesmentioning

confidence: 99%

Section: Individualmentioning

confidence: 99%

Section: Individualmentioning

confidence: 99%

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Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology

et al. 2023

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“…A few studies that compared laparoscopic and robotic hernia repair were explored in associated publications. Bilezikian et al [151] discussed the results of NCT01825187 [109], in which two different lightweight polypropylene meshes were inserted through the two surgical strategies for treating inguinal hernias in 48 patients. It was observed that robotic mesh placement significantly increased insertion time regardless of mesh type, mainly attributed to the mechanics of robotic suturing and the associated learning curve.…”

Section: Clinical Trialsmentioning

confidence: 99%

A Review of Abdominal Meshes for Hernia Repair—Current Status and Emerging Solutions

Najm,

Niculescu,

Gaspar

et al. 2023

Materials

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Abdominal hernias are common issues in the clinical setting, burdening millions of patients worldwide. Associated with pain, decreased quality of life, and severe potential complications, abdominal wall hernias should be treated as soon as possible. Whether an open repair or laparoscopic surgical approach is tackled, mesh reinforcement is generally required to ensure a durable hernia repair. Over the years, numerous mesh products have been made available on the market and in clinical settings, yet each of the currently used meshes presents certain limitations that reflect on treatment outcomes. Thus, mesh development is still ongoing, and emerging solutions have reached various testing stages. In this regard, this paper aims to establish an up-to-date framework on abdominal meshes, briefly overviewing currently available solutions for hernia repair and discussing in detail the most recent advances in the field. Particularly, there are presented the developments in lightweight materials, meshes with improved attachment, antimicrobial fabrics, composite and hybrid textiles, and performant mesh designs, followed by a systematic review of recently completed clinical trials.

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Robot-assisted groin hernia repair is primarily performed by specialized surgeons: a scoping review

et al. 2022

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A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery

Cited by 5 publications

References 15 publications

Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology

Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology

A Review of Abdominal Meshes for Hernia Repair—Current Status and Emerging Solutions

Robot-assisted groin hernia repair is primarily performed by specialized surgeons: a scoping review

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