Evidence map›Paper›PMID 29736474›Full record

ArticleContemporary clinical trials communications2016

Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial).

A Hellinger, F Wotzlaw, V Fackeldey, G Pistorius, M Zdichavsky, R Jünemann, A Buia

Registry-linked trialAbstract read
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In one paragraph

Article in Contemporary clinical trials communications, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02089958 (Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT02089958 completednot on this map

Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study

TypeobservationalSponsorKlinikum FuldaRan2013 to 2015Enrolled102ConditionsIncisional HerniaArmsLaparoscopic incisional hernia repair
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

7 authors.

A HellingerDepartment of General and Visceral Surgery, Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda, Germany.
F WotzlawDepartment of General and Visceral Surgery, Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda, Germany.
V FackeldeyDepartment of General, Vascular and Visceral Surgery, Klinik Kitzinger Land, Kitzingen, Germany.
G PistoriusDepartment of General, Thoracic and Visceral Surgery, Sozialstiftung Bamberg, Bamberg, Germany.
M ZdichavskyDepartment of General, Visceral and Transplantation Surgery, University of Tübingen, Tübingen, Germany.
R JünemannStatConsult, Gesellschaft für klinische und Versorgungsforschung mbH, Magdeburg, Germany.
A BuiaDepartment of General and Visceral Surgery, St. Elisabethen-Krankenhaus, Frankfurt a. M., Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair has been widely used since its first description but has not been standardized. A panel of hernia experts with expertise on the subject "incisional hernia" was established to review existing literature and define a standard approach to laparoscopic IPOM-repair for incisional hernia. All involved surgeons agreed to perform further IPOM-repairs of incisional hernia according to the protocol. METHODS/

designThis article summarizes the development of an open prospective observational multicentre cohort study to analyse the impact of a standardization of laparoscopic IPOM-repair for incisional hernia on clinical outcome and quality of life (health care research study). DISCUSSION: Our literature search found that there is a lack of standardization in the surgical approach to incisional hernia and the use of medical devices. The possibility of different surgical techniques, various meshes and a variety of mesh fixation techniques means that the results on outcome after incisional hernia repair are often not comparable between different studies. We believe there is a need for standardization of the surgical procedure and the use of medical devices in order to make the results more comparable and eliminate confounding factors in interpreting the results of surgical hernia repair. This approach, in our view, will also illustrate the influence of the operative technique on the general quality of surgical treatment of incisional hernias better than a "highly selective" study and will indicate the "reality" of surgical treatment not only in specialist centres.

trial registrationThe LIPOM-trial is registered at www.clinicaltrials.gov, with identifier: NCT02089958.

Indexed as

ASA, American Society of AnesthesiologistsCCS, Carolina Comfort ScaleCDC, Center for Disease Control and PreventionClinical outcomeDSMB, Data safety Management BoardEHS, European Hernia SocietyHP, Hernia PanelIDEAL, Idea Development, Exploration, Assessment, Long-term Follow-upIPOM, Intraperitoneal onlay mesh augmentationLaparoscopic incisional hernia repairLIPOM, Laparoscopic intraperitoneal onlay mesh augmentationLIPOM-TrialNRS, Numerical Rating ScaleProspective observational multicentre cohort trialQuality of lifeTM, Trade markW, Width

Identifiers

PMID29736474
PMCPMC5935894

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Registered trials

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.