Trial reportHernia : the journal of hernias and abdominal wall surgery2012
PerFix™ plug versus 4DDOME(®) implants for inguinal hernia repair: prospective multicentric randomised controlled trial.
Trial report in Hernia : the journal of hernias and abdominal wall surgery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- International guidelines for groin hernia management.Hernia : the journal of hernias and abdominal wall surgery · 2018Guideline
- Do we really need three-dimensional convex inguinal hernia meshes?Hernia : the journal of hernias and abdominal wall surgery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAnterior mesh placement is the standard of care for hernia repair. The use of partially absorbable meshes may limit post-operative pain without altering the durability of the repair. We designed a prospective randomised study, which aims to compare the PerFix™ plug to the 4DDOME(®), a partially absorbable mesh. MATERIALS AND
methodsInguinal hernia patients were prospectively and randomly included in the study. Hernia repair was performed using either the PerFix™ plug (Davol) or the 4DDOME(®) implant (Cousin Biotech). Operative evaluation included type and duration of anaesthesia, characteristics of the incision, post-operative hospital stay and pain evaluated through a visual analogue scale (VAS) at day 1, day 8, month 1, month 6, and year 1. Return to personal or professional activity was evaluated. Quality of life was measured by a SF36 questionnaire at 1, 6, and 12 months' follow-up.
resultsNinety-five patients were prospectively enrolled and randomised to one type of prosthetic repair. The two groups of patients did not differ in terms of clinical characteristics, type of hernia, and intra-operative course. When comparing PerFix™ plug to 4DDOME(®) groups, the post-operative course was similar: pain (VAS 3.42 (SD 1.83) vs. 3.82 (SD 2.0), p = 0.69); in-hospital stay (2.12 (SD 1.36) vs. 2.25 (SD 1.62), p = 0.67); and return to personal (9.39 days (SD 8.15) vs. 9.48 days (SD 11.68), p = 0.96) and professional activity (25.71 days (SD 17.47) vs. 22.82 days (SD 18.10), p = 0.62). Post-operative pain and discomfort assessed by the SF36 questionnaire at day 8, months 1, 6, and 12 were similar, but significantly lower after 4DDOME(®) repair at 3 months for "pain" (p = 0.021) and at 6 months for "health" criteria (p = 0.028).
conclusionThis clinical study demonstrated similar short-term results. The 4DDOME(®) was associated with less pain and discomfort after 3 and 6 months. The combination of the dome shape and the double component mesh including an absorbable part meet the conflicting demands of early strength with a long-term low-weight material to minimise shrinkage and fibrosis. This design represents a potential advance in anterior tension-free hernia repair with mesh.
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Registered trials
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