Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
NCT ID: NCT02787772
Last Updated: 2016-06-09
Study Results
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Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2009-01-31
2016-01-31
Brief Summary
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Methods: A prospective study of cirrhotic patients with abdominal wall hernia during January 2009 to November 2014. Demographics, characteristics of underlying liver disease, type of hernia, complications and mortality of 246 enrolled patients were collected. Elective hernia repair was performed in 57 unselected patients, 186 patients were kept in clinical follow up. During follow up urgent hernia surgery was performed when unavoidable
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Detailed Description
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Inguinal hernias also develop due to higher intra-abdominal pressure due to ascites; they often result in large hernia sacs reaching the scrotum. In addition such large hernias are responsible for reduced mobility and quality of life.
The ideal treatment would be to correct both the abdominal wall hernia and the underlying liver disease. However, there are insufficient liver´s donors, so the liver transplantation (LT) waiting list continuously grows. This explains why the majority of abdominal wall hernias in cirrhotic patients remain untreated for several years.
Therefore, most cirrhotic hernia patients are followed conservatively, the surgical treatment being reserved when complications occur. Such expectative attitude is explained by the high postoperative morbidity and mortality. Although, urgent surgery in such patients impose a higher morbidity and mortality compared to elective hernia surgery.
No prospective study is reported comparing the incidence of complications in cirrhotic hernia patients which are just observed or submitted to elective surgery. The aim of this study is to analyze the results of the surgical treatment of abdominal wall hernias in cirrhotic patients.
A prospective study was conducted in patients having documented cirrhosis and abdominal hernia that were followed at the Department of Liver Transplant of University of São Paulo during the period January 2009 to November 2014. All patients included in the study signed an informed consent. At that moment they were randomized for elective hernia repair or clinical follow-up accordingly to their Child-Pugh (CTP) status. Patients who developed local hernia complications during observation underwent emergency hernia surgery.
Cirrhosis was diagnosed by liver tests and confirmed with liver imaging or biopsy. Abdominal wall hernias were diagnosed by physical examination and ultrasound and/or CT scans when necessary.
All patients were managed for their liver disease using individualized laboratory tests, endoscopic and ultrasound work-up. Patients with decompensated liver disease were medically optimized using diuretics in order to control the ascites.
Variables studied were: age, sex, etiology of liver disease, CTP classification, MELD (model of end stage liver disease) score, ascites, need of paracentesis, diabetes mellitus, renal failure and abdominal hernia type, morbidity and mortality. In patients who underwent surgery length of hospital stay, post-operative complications, grade of complications accordingly Clavien and infection were also recorded. Post-operative mortality was considered up to 30-days. End points of the study were death, hernia recurrence or LT.
This study was approved by the Institutional Review Board of University of Sao Paulo.
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Elective Hernia Repair
Elective abdominal wall hernia surgery was performed in randomized cirrhotic patients.
Elective Hernia repair
abdominal wall hernia repair using onlay mesh.
Clinical follow up
Cirrhotic patients were kept in clinical follow up concerning their abdominal wall hernia.
If a complication occured at the hernia site (such as skin rupture, bowel strangulation,..) the patient underwent emergency hernia repair.
No interventions assigned to this group
Interventions
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Elective Hernia repair
abdominal wall hernia repair using onlay mesh.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Wellington Andraus
Prof. PhD. MD
References
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Belghiti J, Durand F. Abdominal wall hernias in the setting of cirrhosis. Semin Liver Dis. 1997;17(3):219-26. doi: 10.1055/s-2007-1007199.
Carbonell AM, Wolfe LG, DeMaria EJ. Poor outcomes in cirrhosis-associated hernia repair: a nationwide cohort study of 32,033 patients. Hernia. 2005 Dec;9(4):353-7. doi: 10.1007/s10029-005-0022-x. Epub 2005 Aug 27.
Marsman HA, Heisterkamp J, Halm JA, Tilanus HW, Metselaar HJ, Kazemier G. Management in patients with liver cirrhosis and an umbilical hernia. Surgery. 2007 Sep;142(3):372-5. doi: 10.1016/j.surg.2007.05.006.
Silva FD, Andraus W, Pinheiro RS, Arantes-Junior RM, Lemes MP, Ducatti Lde S, D'albuquerque LA. Abdominal and inguinal hernia in cirrhotic patients: what's the best approach? Arq Bras Cir Dig. 2012 Jan-Mar;25(1):52-5. doi: 10.1590/s0102-67202012000100012. English, Portuguese.
Mansour A, Watson W, Shayani V, Pickleman J. Abdominal operations in patients with cirrhosis: still a major surgical challenge. Surgery. 1997 Oct;122(4):730-5; discussion 735-6. doi: 10.1016/s0039-6060(97)90080-5.
Hassan AM, Salama AF, Hamdy H, Elsebae MM, Abdelaziz AM, Elzayat WA. Outcome of sublay mesh repair in non-complicated umbilical hernia with liver cirrhosis and ascites. Int J Surg. 2014;12(2):181-5. doi: 10.1016/j.ijsu.2013.12.009. Epub 2013 Dec 28.
Ammar SA. Management of complicated umbilical hernias in cirrhotic patients using permanent mesh: randomized clinical trial. Hernia. 2010 Feb;14(1):35-8. doi: 10.1007/s10029-009-0556-4. Epub 2009 Aug 29.
Andraus W, Pinheiro RS, Lai Q, Haddad LBP, Nacif LS, D'Albuquerque LAC, Lerut J. Abdominal wall hernia in cirrhotic patients: emergency surgery results in higher morbidity and mortality. BMC Surg. 2015 May 21;15:65. doi: 10.1186/s12893-015-0052-y.
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 Feb;26(1):47-59. doi: 10.1016/j.bpg.2012.01.010.
Oh HK, Kim H, Ryoo S, Choe EK, Park KJ. Inguinal hernia repair in patients with cirrhosis is not associated with increased risk of complications and recurrence. World J Surg. 2011 Jun;35(6):1229-33; discussion 1234. doi: 10.1007/s00268-011-1007-9.
Other Identifiers
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0937/09
Identifier Type: -
Identifier Source: org_study_id
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