Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis (CRUCIAL)

Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis

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

The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates. The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.

Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.

Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.

Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.

Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.

The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery

Inclusion Criteria: Primary Umbilical hernia Liver cirrhosis Ascites (US proven) Age ≥ 18 years Signed Informed consent Exclusion Criteria: Recurrent umbilical hernia Midline laparotomy in medical history ASA1 score IV or above Incarcerated hernia related emergency procedures Patent umbilical vein; >5mm Expected time to Ltx <3 months

de Goede B, van Rooijen MMJ, van Kempen BJH, Polak WG, de Man RA, Taimr P, Lange JF, Metselaar HJ, Kazemier G. Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial). Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.