Evidence map›Paper›PMID 30651127›Full record

ArticleTrials2019

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial.

C S Seefeldt, J S Meyer, J Knievel, A Rieger, R Geißen, R Lefering, M M Heiss

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Review
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

7 authors at 2 institutions in 1 country.

C S SeefeldtDepartment of Visceral, Vascular and Transplant Surgery/Chair of Surgery of the University of Witten-Herdecke, Krankenhaus Merheim, Kliniken der Stadt Köln, Ostmerheimer Straße. 200, 51109, Köln, Germany.ORCID http://orcid.org/0000-0002-6372-1273
J S MeyerDepartment of Visceral, Vascular and Transplant Surgery/Chair of Surgery of the University of Witten-Herdecke, Krankenhaus Merheim, Kliniken der Stadt Köln, Ostmerheimer Straße. 200, 51109, Köln, Germany.ORCID http://orcid.org/0000-0002-3757-2411
J KnievelInstitut für Forschung in der Operativen Medizin der Universität Witten/Herdecke, Ostmerheimer Straße 200, Haus 38, 51109, Köln, Germany.ORCID http://orcid.org/0000-0002-6213-590X
A RiegerDepartment of Visceral, Vascular and Transplant Surgery/Chair of Surgery of the University of Witten-Herdecke, Krankenhaus Merheim, Kliniken der Stadt Köln, Ostmerheimer Straße. 200, 51109, Köln, Germany.ORCID http://orcid.org/0000-0002-4145-5322
R GeißenZentrum für klinische Studien der Universität Witten/Herdecke, Alfred-Herrhausen-Str. 50, 58448, Witten, Germany.ORCID http://orcid.org/0000-0002-6496-4613
R LeferingInstitut für Forschung in der Operativen Medizin der Universität Witten/Herdecke, Ostmerheimer Straße 200, Haus 38, 51109, Köln, Germany.ORCID http://orcid.org/0000-0002-0141-1747
M M HeissDepartment of Visceral, Vascular and Transplant Surgery/Chair of Surgery of the University of Witten-Herdecke, Krankenhaus Merheim, Kliniken der Stadt Köln, Ostmerheimer Straße. 200, 51109, Köln, Germany. HeissM@kliniken-koeln.de.
Kliniken der Stadt Köln · DEWitten/Herdecke University · DE

Funding

Deutsche Forschungsgemeinschaft HE 1586/5-1
6 · The paper itself

Abstract

backgroundInguinal hernia repair is one of the most common surgical operations globally; more than 20 million groin herniae are repaired annually worldwide. Recurrence after an inguinal hernia operation is a considerable clinical problem. Another remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is increasing evidence that biological meshes could be advantageous concerning the occurrence of chronic pain due to different postoperative remodeling, without the disadvantages of a life-long implant. We hypothesize that the use of a biological mesh reduces postoperative pain without being inferior in terms of recurrence rate compared with a synthetic mesh. METHODS/

designThe trial compares possible the advantages of biological matrices to synthetic meshes in laparo-endoscopic inguinal hernia repair. Four hundred and ninety-six patients with primary bilateral inguinal herniae in 20 German hernia centers will be enrolled. Biological mesh is used for one of the bilateral herniae, the other side will be operated on with a synthetic mesh. Randomization will preset which side is repaired with which material and trial participants will not be informed about the location of each mesh type. The primary endpoints will be intensity of postoperative local pain and the incidence of recurrent hernia after 2 years. DISCUSSION: There is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair. Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent use of biological meshes, we can expect our trial to have a direct implication on hernia-repair standards.

trial registrationGerman Clinical Trials Register, ID: DRKS00010178 . Registered on 16.June.2016. BIOLAP underwent full external peer review as part of the funding process with the German Research Foundation.

Indexed as

Surgical MeshEquipment DesignGermanyHernia, InguinalHerniorrhaphyHumansLaparoscopyMulticenter Studies as TopicPostoperative PainRandomized Controlled Trials as TopicRecurrenceTime FactorsTreatment OutcomeBiological meshBiomeshBlinded trialHernia inguinalisInguinal herniaLaparo-endoscopic hernia repairRandomized trialSelf-controlled trialTAPPTEP

Identifiers

PMID30651127
PMCPMC6335692
OpenAlexW2910648638

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.