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, 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

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: Ascites; Liver cirrhosis; Liver transplantation; Umbilical hernia.

Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig 1
Fig 1
Time to first complication. This complication can be either minor or major (including death). Censored patients are marked with “+”
Fig 2
Fig 2
Time to death. Censored patients are marked with “+”

References

    1. Chapman CB, Snell AM, Rowntree LG. Decompensated portal cirrhosis: report of one hundred and twelve cases. JAMA. 1931;97(4):237–244. doi: 10.1001/jama.1931.02730040019008.
    1. Belghiti J, Durand F. Abdominal wall hernias in the setting of cirrhosis. Semin Liver Dis. 1997;17(3):219–226. doi: 10.1055/s-2007-1007199.
    1. Shlomovitz E, Quan D, Etemad-Rezai R, McAlister VC. Association of recanalization of the left umbilical vein with umbilical hernia in patients with liver disease. Liver Transpl. 2005;11(10):1298–1299. doi: 10.1002/lt.20579.
    1. O’Hara ET, Oliai A, Patek AJ, Jr, Nabseth DC. Management of umbilical hernias associated with hepatic cirrhosis and ascites. Ann Surg. 1975;181(1):85–87. doi: 10.1097/00000658-197501000-00018.
    1. Leonetti JP, Aranha GV, Wilkinson WA, Stanley M, Greenlee HB. Umbilical herniorrhaphy in cirrhotic patients. Arch Surg. 1984;119(4):442–445. doi: 10.1001/archsurg.1984.01390160072014.
    1. Cho SW, Bhayani N, Newell P, Cassera MA, Hammill CW, Wolf RF, Hansen PD. Umbilical hernia repair in patients with signs of portal hypertension: surgical outcome and predictors of mortality. Arch Surg. 2012;147(9):864–869. doi: 10.1001/archsurg.2012.1663.
    1. Reissfelder C, Radeleff B, Mehrabi A, Rahbari NN, Weitz J, Buchler MW, et al. Emergency liver transplantation after umbilical hernia repair: a case report. Transplant Proc. 2009;41(10):4428–4430. doi: 10.1016/j.transproceed.2009.08.068.
    1. Marsman HA, Heisterkamp J, Halm JA, Tilanus HW, Metselaar HJ, Kazemier G. Management in patients with liver cirrhosis and an umbilical hernia. Surgery. 2007;142(3):372–375. doi: 10.1016/j.surg.2007.05.006.
    1. Schumpelick V, Treutner KH, Arlt G. Inguinal-Hernia Repair in Adults. Lancet. 1994;344(8919):375–379. doi: 10.1016/S0140-6736(94)91404-4.
    1. Primatesta P, Goldacre MJ. Inguinal hernia repair: incidence of elective and emergency surgery, readmission and mortality. Int J Epidemiol. 1996;25(4):835–839. doi: 10.1093/ije/25.4.835.
    1. van den Heuvel B, Dwars BJ, Klassen DR, Bonjer HJ. Is surgical repair of an asymptomatic groin hernia appropriate? A review. Hernia. 2011;15(3):251–259. doi: 10.1007/s10029-011-0796-y.
    1. de Goede B, Klitsie PJ, Lange JF, Metselaar HJ, Kazemier G. Morbidity and mortality related to non-hepatic surgery in patients with liver cirrhosis: a systematic review. Best Pract Res Clin Gastroenterol. 2012;26(1):47–59. doi: 10.1016/j.bpg.2012.01.010.
    1. Belghiti J, Desgrandchamps F, Farges O, Fekete F. Herniorrhaphy and concomitant peritoneovenous shunting in cirrhotic patients with umbilical hernia. World J Surg. 1990;14(2):242–246. doi: 10.1007/BF01664882.
    1. Eker HH, van Ramshorst GH, de Goede B, Tilanus HW, Metselaar HJ, de Man RA, Lange JF, Kazemier G. A prospective study on elective umbilical hernia repair in patients with liver cirrhosis and ascites. Surgery. 2011;150(3):542–546. doi: 10.1016/j.surg.2011.02.026.
    1. Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018;391(10123):860–869. doi: 10.1016/S0140-6736(18)30298-8.
    1. Centers for Disease Control and Prevention (CDC) (2017) Guideline for the prevention of surgical site infection. [cited 2017 March 2]. Available from: .
    1. Krafcik BM, Farber A, Eslami MH, Kalish JA, Rybin D, Doros G, Shah NK, Siracuse JJ. The role of model for end-stage liver disease (MELD) score in predicting outcomes for lower extremity bypass. J Vasc Surg. 2016;64(1):124–130. doi: 10.1016/j.jvs.2016.01.033.
    1. Northup PG, Wanamaker RC, Lee VD, Adams RB, Berg CL. Model for end-stage liver disease (MELD) predicts nontransplant surgical mortality in patients with cirrhosis. Ann Surg. 2005;242(2):244–251. doi: 10.1097/01.sla.0000171327.29262.e0.
    1. Morimoto N, Okada K, Okita Y. The model for end-stage liver disease (MELD) predicts early and late outcomes of cardiovascular operations in patients with liver cirrhosis. Ann Thorac Surg. 2013;96(5):1672–1678. doi: 10.1016/j.athoracsur.2013.06.007.
    1. Lau T, Ahmad J. Clinical applications of the model for end-stage liver disease (MELD) in hepatic medicine. Hepat Med. 2013;5:1–10.
    1. Elnahas A, Nguyen GC, Okrainec A, Quereshy F, Jackson TD. The effect of underlying liver disease on short-term outcomes following bariatric surgery. Surg Endosc. 2014;28(9):2708–2712. doi: 10.1007/s00464-014-3532-8.
    1. Lange EO, Jensen CC, Melton GB, Madoff RD, Kwaan MR. Relationship between model for end-stage liver disease score and 30-day outcomes for patients undergoing elective colorectal resections: an American College of Surgeons-National Surgical Quality Improvement Program study. Dis Colon Rectum. 2015;58(5):494–501. doi: 10.1097/DCR.0000000000000358.
    1. Pinheiro RS, Andraus W, Waisberg DR, Nacif LS, Ducatti L, Rocha-Santos V, et al. Abdominal hernias in cirrhotic patients: surgery or conservative treatment? Results of a prospective cohort study in a high volume center: cohort study. Ann Med Surg (Lond) 2020;49:9–13. doi: 10.1016/j.amsu.2019.11.009.
    1. Pedersen JS, Bendtsen F, Moller S. Management of cirrhotic ascites. Ther Adv Chronic Dis. 2015;6(3):124–137. doi: 10.1177/2040622315580069.
    1. Huelin P, Fortea JI, Crepso J, Fábrega E (2017) Ascites: treatment, complications, and prognosis. In: Rodrigo L (ed) Ascites: physiopathology, treatment, complications and prognosis. IntechOpen
    1. Kuiper JJ, van Buuren HR, de Man RA. Ascites in cirrhosis: a review of management and complications. Neth J Med. 2007;65(8):283–288.
    1. Gray SH, Vick CC, Graham LA, Finan KR, Neumayer LA, Hawn MT. Umbilical herniorrhapy in cirrhosis: improved outcomes with elective repair. J Gastrointest Surg. 2008;12(4):675–681. doi: 10.1007/s11605-008-0496-9.
    1. Coelho JC, Claus CM, Campos AC, Costa MA, Blum C. Umbilical hernia in patients with liver cirrhosis: a surgical challenge. World J Gastrointest Surg. 2016;8(7):476–482. doi: 10.4240/wjgs.v8.i7.476.
    1. Rosemurgy AS, Statman RC, Murphy CG, Albrink MH, McAllister EW. Postoperative ascitic leaks: the ongoing challenge. Surgery. 1992;111(6):623–625.
    1. McKay A, Dixon E, Bathe O, Sutherland F. Umbilical hernia repair in the presence of cirrhosis and ascites: results of a survey and review of the literature. Hernia. 2009;13(5):461–468. doi: 10.1007/s10029-009-0535-9.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner