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OpenTrials
Completed

NCT Number: NCT02787772

Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Elective Hernia repair

Procedure

abdominal wall hernia repair using onlay mesh.

Primary outcomes

  1. 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.

Secondary outcomes

  1. post operative mortality

    Time frame: 30 days

    mortality after elective or urgent hernia repair in cirrhotic patients

  2. post operative morbidity

    Time frame: 30 days

    post operative complications after elective or urgent hernia repair in cirrhotic patients

  3. incidence of complications in patients clinical follow up

    Time frame: 4 years

    Incidence of hernia complications leading to emergency hernia repair

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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