Clinical trial NCT02787772: Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
Official title: Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Hernia
Ascites
Surgery
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: mortality during follow up
timeFrame: 4 years
Secondary outcomes:
measure: post operative mortality
timeFrame: 30 days
measure: post operative morbidity
timeFrame: 30 days
measure: incidence of complications in patients clinical follow up
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
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