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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
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 26, 2016
    Last Updated
    June 8, 2016
    Sponsor
    University of Sao Paulo General Hospital
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    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
    16132187
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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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