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

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.

Umbilical Hernia Repair in Patients with Cirrhosis and in Patients with Severe Comorbidities—A Nationwide Cohort Study

“…However, the evidence was graded as 'very low' [6]. Studies investigating elective umbilical hernia repair in patients with decompensated cirrhosis did report any mortality related to elective hernia repair after a follow-up of at least 6 months [14,[21][22][23]. Pre-and postoperative control of ascites is associated with reduced risk of reoperation and hernia recurrence [10,[24][25][26].…”

Assessing the risk of surgery in patients with cirrhosis

“…While there were no significant differences in patient morbidity, likely related to small sample size, patients with conservative management had higher numerical rates of complications (77.8%) as compared with those who underwent elective repair (50.0%). 63 Several risk factors for adverse outcomes after hernia repair have been identified in retrospective studies such as a MELD >15, hypoalbuminemia, anemia, and preoperative small bowel obstruction. 28 , 64 These studies suggest that elective hernia repair is safe in selected patients with cirrhosis, although ongoing studies are needed to identify patients most likely to benefit from a surgical approach.…”

Risk factors for decompensation and death following umbilical hernia repair in patients with end-stage liver disease

“…While this series of 108 patients is one of the largest reported for patients with ESLD undergoing umbilical hernia repair, we were unable to report outcomes for patients with ESLD who had an umbilical hernia managed without surgery. Previous studies have compared outcomes of elective surgery versus conservative management [7], but limited data exist on outcomes without surgery in the emergency setting. Further prospective studies are warranted to inform practice and decision-making in patients presenting with ESLD and an umbilical hernia, as well as further delineate the natural history of this condition.…”

“…These risks are further increased when surgery is undertaken as an emergency [6]. Currently, some centres advocate elective repair to avoid the added risk of emergency surgery [3,7]. Alternatively, a proportion of patients may be eligible for liver transplantation [8,9], and deferring repair to the time of transplantation may be preferred.…”