Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results
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CONTROLLED CLINICAL TRIALS
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 1,2 & M. M. J. van Rooijen 1 H. J. Metselaar 4 & G. Kazemier 5
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& B. J. H. van Kempen & W. G. Polak & R. A. de Man & P. Taimr & J. F. Lange
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Received: 20 September 2020 / Accepted: 15 November 2020 # The Author(s) 2020
Abstract Purpose To establish optimal management of patients with an umbilical hernia complicated by liver cirrhosis and ascites. Methods Patients 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. Results Thirty-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). Conclusion This 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 registration Clinicaltrials.gov, NCT01421550, on 23 August 2011. Keywords Umbilical hernia . Liver cirrhosis . Ascites . Liver transplantation
B. de Goede and M.M.J. van Rooijen contributed equally and share the first authorship. * M. M. J. van Rooijen [email protected] 1
Department of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA Rotterdam, The Netherlands
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Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands
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Department of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands
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Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
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Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Center - VU University Amsterdam, Amsterdam, The Netherlands
Introduction Umbilical hernias are common in patients with liver cirrhosis and ascites, with an inciden
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