Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
Primary Purpose
Liver Cirrhosis, Hernia, Ascites
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elective Hernia repair
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- patients with chronic liver disease (cirrhosis) and abdominal wall hernia.
Exclusion Criteria:
- patients who didn´t want to underwent hernia repair.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Elective Hernia Repair
Clinical follow up
Arm Description
Elective abdominal wall hernia surgery was performed in randomized cirrhotic patients.
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.
Outcomes
Primary Outcome Measures
mortality during follow up
Compare long-term survival in cirrhotic patients with abdominal wall hernia who underwent elective hernia repair or maintained in clinical follow up.
Secondary Outcome Measures
post operative mortality
mortality after elective or urgent hernia repair in cirrhotic patients
post operative morbidity
post operative complications after elective or urgent hernia repair in cirrhotic patients
incidence of complications in patients clinical follow up
Incidence of hernia complications leading to emergency hernia repair
Full Information
NCT ID
NCT02787772
First Posted
May 26, 2016
Last Updated
June 8, 2016
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02787772
Brief Title
Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
Official Title
Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cirrhotic patients have a high incidence of abdominal wall hernias. Ascites and sarcopenia are risk factors to development of bigger hernias and frequent need for urgent surgery due parietal complications. However, hernia surgery is usually delayed in cirrhotic patients because of high morbidity and mortality.
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
Detailed Description
Abdominal wall hernias are frequent in cirrhotic patients. The incidence of umbilical hernia´s reaches over 20% in compensated cirrhosis and even 40% in patients with ascites. Several risk factors explain the development of umbilical hernia in these patients, such as, increased intra-abdominal pressure caused by ascites; abdominal aponeurosis weakness due sarcopenia ; and recanalization of the umbilical vein. These hernias develop great hernial sacs, especially when ascites is present. All these risk factors also explain their high complication rate due to the development of pressure ulcers, skin rupture, ascites leak and bacterial peritonitis. Moreover pain is a common associated symptom.
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.
Wait and see was the advocated policy before this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Hernia, Ascites, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elective Hernia Repair
Arm Type
Experimental
Arm Description
Elective abdominal wall hernia surgery was performed in randomized cirrhotic patients.
Arm Title
Clinical follow up
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Elective Hernia repair
Intervention Description
abdominal wall hernia repair using onlay mesh.
Primary Outcome Measure Information:
Title
mortality during follow up
Description
Compare long-term survival in cirrhotic patients with abdominal wall hernia who underwent elective hernia repair or maintained in clinical follow up.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
post operative mortality
Description
mortality after elective or urgent hernia repair in cirrhotic patients
Time Frame
30 days
Title
post operative morbidity
Description
post operative complications after elective or urgent hernia repair in cirrhotic patients
Time Frame
30 days
Title
incidence of complications in patients clinical follow up
Description
Incidence of hernia complications leading to emergency hernia repair
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with chronic liver disease (cirrhosis) and abdominal wall hernia.
Exclusion Criteria:
patients who didn´t want to underwent hernia repair.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9308126
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
17723889
Citation
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.
Results Reference
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PubMed Identifier
22569980
Citation
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.
Results Reference
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PubMed Identifier
9347849
Citation
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.
Results Reference
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PubMed Identifier
24378913
Citation
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.
Results Reference
background
PubMed Identifier
19727551
Citation
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.
Results Reference
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PubMed Identifier
25990110
Citation
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.
Results Reference
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PubMed Identifier
22482525
Citation
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.
Results Reference
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PubMed Identifier
21365342
Citation
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.
Results Reference
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Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
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