Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?

June 8, 2016 updated by: Wellington Andraus, University of Sao Paulo General Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with chronic liver disease (cirrhosis) and abdominal wall hernia.

Exclusion Criteria:

  • patients who didn´t want to underwent hernia repair.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elective Hernia Repair
Elective abdominal wall hernia surgery was performed in randomized cirrhotic patients.
Procedure: Elective Hernia repair
abdominal wall hernia repair using onlay mesh.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality during follow up
Time Frame: 4 years
Compare long-term survival in cirrhotic patients with abdominal wall hernia who underwent elective hernia repair or maintained in clinical follow up.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative mortality
Time Frame: 30 days
mortality after elective or urgent hernia repair in cirrhotic patients
30 days
post operative morbidity
Time Frame: 30 days
post operative complications after elective or urgent hernia repair in cirrhotic patients
30 days
incidence of complications in patients clinical follow up
Time Frame: 4 years
Incidence of hernia complications leading to emergency hernia repair
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0937/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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