Evidence map›Paper›PMID 26139491›Full record

Trial reportSurgical endoscopy2016

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial.

Maciej Pawlak, Ralf-Dieter Hilgers, Kamil Bury, Andrzej Lehmann, Radosław Owczuk, Maciej Śmietański

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 5% of its field
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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Mesh fixation techniques in primary ventral or incisional hernia repair.The Cochrane database of systematic reviews · 2021
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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

6 authors at 2 institutions in 2 countries.

Maciej PawlakDepartment of General Surgery, Ceynowa Hospital, Wejherowo, Poland. pawlakmd@gmail.com.
Ralf-Dieter HilgersDepartment of Medical Statistics, RWTH Aachen University, Aachen, Germany.
Kamil BuryDepartment of Cardiac and Vascular Surgery, Medical University of Gdańsk, Gdańsk, Poland.
Andrzej LehmannDepartment of General Surgery, Ceynowa Hospital, Wejherowo, Poland.
Radosław OwczukDepartment of Anesthesiology and Intensive Care, Medical University of Gdańsk, Gdańsk, Poland.
Maciej ŚmietańskiII Department of Radiology, Medical University of Gdańsk, Gdańsk, Poland.
Gdańsk Medical University · PLRWTH Aachen University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients' need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.

methodsA single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.

resultsDuring the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (p < 0.0001) and no difference after 7 days (p = 0. 7019). The pain intensity decreased significantly over time (p < 0.0001) and was significantly higher in the PH group (p < 0.0001).

conclusionsAlthough this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.

Indexed as

Surgical MeshAdultAgedAged, 80 and overFemaleHernia, VentralHerniorrhaphyHumansLaparoscopyMaleMiddle AgedPostoperative PainProspective StudiesRecurrenceVisual Analog ScaleIncisional herniaIntraperitoneal onlay meshLaparoscopic abdominal wall hernia repairVentral hernia

Identifiers

PMID26139491
OpenAlexW746984091

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.