Evidence map›Paper›PMID 31842966›Full record

ArticleTrials2019

Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial): study protocol for a randomized controlled trial.

Patrick Heger, Manuel Feißt, Johannes Krisam, Christina Klose, Colette Dörr-Harim, Solveig Tenckhoff, Markus W Büchler, Markus K Diener, André L Mihaljevic

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 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

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

9 authors at 2 institutions in 1 country.

Patrick HegerDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Manuel FeißtInstitute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Johannes KrisamInstitute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Christina KloseInstitute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Colette Dörr-HarimDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Solveig TenckhoffThe Study Center of the German Surgical Society (SDGC), University Hospital Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Markus W BüchlerDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Markus K DienerDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
André L MihaljevicDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. andre.mihaljevic@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0003-1902-657X
German Society of Surgery · DEHeidelberg University · DE

Funding

Deutsche Forschungsgemeinschaft (DE) 410901776
6 · The paper itself

Abstract

backgroundIncisional hernias are among the most frequent complications following abdominal surgery and cause substantial morbidity, impaired health-related quality of life and costs. Despite improvements in abdominal wall closure techniques, the risk for developing an incisional hernia is reported to be between 10 and 30% following midline laparotomies. There have been two recent innovations with promising results to reduce hernia risks, namely the small stitches technique and the placement of a prophylactic mesh. So far, these two techniques have not been evaluated in combination.

methodsThe HULC trial is a multicentre, randomized controlled, observer- and patient-blinded surgical effectiveness trial with two parallel study groups. A total of 812 patients scheduled for elective abdominal surgery via a midline laparotomy will be randomized in 12 centres after informed consent. Patients will be randomly assigned to the control group receiving closure of the midline incision with a slowly absorbable monofilament suture in the small stitches technique or to the intervention group, who will receive a small stitches closure followed by augmentation with a light-weight polypropylene mesh in the onlay technique. The primary endpoint will be the occurrence of incisional hernias, as defined by the European Hernia Society, within 24 months after surgery. Further perioperative parameters, as well as patient-reported outcomes, will be analysed as secondary outcomes. DISCUSSION: The HULC trial will address the yet unanswered question of whether a combination of small stitched fascial closure and onlay mesh augmentation after elective midline laparotomies reduces the risk of incisional hernias. The HULC trial marks the logical and innovative next step in the development of a safe abdominal closure technique.

trial registrationGerman Clinical Trials Register, DRKS00017517. Registered on 24th June 2019.

Indexed as

Surgical MeshAbdominal Wound Closure TechniquesDouble-Blind MethodGermanyHernia, AbdominalHumansIncisional HerniaMulticenter Studies as TopicRandomized Controlled Trials as TopicSuture TechniquesTime FactorsTreatment OutcomeAbdominal wall closureIncisional herniaLaparotomyOnlay mesh augmentationRandomized controlled trialSmall stitches techniqueSurgical site infection

Identifiers

PMID31842966
PMCPMC6915967
OpenAlexW2994825355

What OpenQuestion holds

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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.