Evidence map›Paper›PMID 33237442›Full record

Trial reportLangenbeck's archives of surgery2021

Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial).

B de Goede, M M J van Rooijen, B J H van Kempen, W G Polak, R A de Man, P Taimr, J F Lange, H J Metselaar, G Kazemier

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Langenbeck's archives of surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01421550 (Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT01421550 phase3unknown statusnot on this map

Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial

TypeinterventionalSponsorErasmus Medical CenterRan2011 to 2015Enrolled100ConditionsUmbilical Hernia, Liver Cirrhosis, AscitesArmsConservative treatment, Surgical repair
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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 1 institution in 1 country.

B de GoedeDepartment of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
M M J van RooijenDepartment of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands. m.vanrooijen@erasmusmc.nl.ORCID http://orcid.org/0000-0002-1037-6883
B J H van KempenDepartment of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
W G PolakDepartment of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
R A de ManDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
P TaimrDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
J F LangeDepartment of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
H J MetselaarDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
G KazemierDepartment of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Center - VU University Amsterdam, Amsterdam, The Netherlands.
Erasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo establish optimal management of patients with an umbilical hernia complicated by liver cirrhosis and ascites.

methodsPatients with an umbilical hernia and liver cirrhosis and ascites were randomly assigned to receive either elective repair or conservative treatment. The primary endpoint was overall morbidity related to the umbilical hernia or its treatment after 24 months of follow-up. Secondary endpoints included the severity of these hernia-related complications, quality of life, and cumulative hernia recurrence rate.

resultsThirty-four patients were included in the study. Sixteen patients were randomly assigned to elective repair and 18 to conservative treatment. After 24 months, 8 patients (50%) assigned to elective repair compared to 14 patients (77.8%) assigned to conservative treatment had a complication related to the umbilical hernia or its repair. A recurrent hernia was reported in 16.7% of patients who underwent repair. For the secondary endpoint, quality of life through the physical (PCS) and mental component score (MCS) showed no significant differences between groups at 12 months of follow-up (mean difference PCS 11.95, 95% CI - 0.87 to 24.77; MCS 10.04, 95% CI - 2.78 to 22.86).

conclusionThis trial could not show a relevant difference in overall morbidity after 24 months of follow-up in favor of elective umbilical hernia repair, because of the limited number of patients included. However, elective repair of umbilical hernia in patients with liver cirrhosis and ascites appears feasible, nudging its implementation into daily practice further, particularly for patients experiencing complaints.

trial registrationClinicaltrials.gov , NCT01421550, on 23 August 2011.

Indexed as

Hernia, UmbilicalAscitesConservative TreatmentHerniorrhaphyHumansLiver CirrhosisQuality of LifeRecurrenceAscitesLiver cirrhosisLiver transplantationUmbilical hernia

Identifiers

PMID33237442
PMCPMC7870599
OpenAlexW3108234544

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.