Elective Umbilical Hernia Repair in Patients With Cirrhosis

NCT04687579 | Unknown DMC

• 1 other identifier: HEROIC21
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liver cirrhosis is a frequent and severe chronic disease. About 20 % of patients with liver cirrhosis develop umbilical hernias. In comparison, the prevalence in the general population is around 2 %. Patients with liver cirrhosis are often neglected and are not offered equal surgical treatments compared with other patient groups with chronic diseases due to fear of postoperative complications. The current literature is sparse, and many questions remain to be answered, such as timing of repair, risk profile, preoperative staging of the liver disease, possible optimization before surgery, repair technique, and postoperative care. Moreover, nationwide data are lacking. The management of umbilical hernias in patients with cirrhosis is debated. Recently, European Hernia Society published guidelines stating that elective hernia repair may be safe, and that emergency repair is associated with a high rate of morbidity and mortality. Nonetheless, surgeons remain reluctant to perform elective surgery on these patients due to fear of complications and mortality. The evidence supporting the guidelines is sparse and consists of small, low quality studies. One of the major concerns is that the existing studies failed to use clear and well-described definitions of the underlying severity of the liver disease. The rate of emergency repair may be much higher in patients with liver cirrhosis compared with the general population but there is no data available. The rate of emergency vs elective repair in patients with liver cirrhosis in Denmark is unknown, as well as the rate of reoperation for complications and readmission. Finally, we hypothesize that these patients may benefit from a more proactive approach with early diagnosis of their umbilical hernia by screening, preoperative optimization, and early elective hernia repair, but the effect of this hypothesis needs further evaluation.

Conditions

Cirrhosis, Umbilical Hernia

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  1. Death 2. Life-threatening adverse experience after surgery 3. Inpatient hospitalization or prolongation of existing hospitalization (for \> 24 hours) 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions

  6 months after umbilical hernia repair and/or inclusion

Secondary Outcomes (1)

• Adverse Events

  6 months after umbilical hernia repair and/or inclusion

Study Arms (2)

Umbilical hernia repair

EXPERIMENTAL

Patients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions.

Other: Screening; Procedure: Preoperative optimization; Procedure: Umbilical hernia repair

Watchful waiting

OTHER

Patients who do not agree for operation but consent for follow-up. Patients will be followed in the whole inclusion period and can at any time change their preference if they wish to undergo surgery.

Other: Screening

Interventions

Screening OTHER

Screening: All health professionals at the hospitals will participate in the screening of umbilical hernia. The screening will be done in the outpatient clinic, the Emergency Department and at the hospital wards.

Umbilical hernia repair; Watchful waiting

Preoperative optimization PROCEDURE

Ascites will be drained using percutaneous drainage or PleurX. Diuretics be used to control ascites preoperative. Haemoglobin \< 5 mmol/L indicates the need for red blood cell concentrates using two dosage SAG-M (350-400 mL of red blood cell concentrates in each dose) will be done. Thrombocytopenia \< 150 10\^9/L will be treated with a TPO-analog using avatrombopag 40-60 mg dispensed as an intravenous fluid. Culture verified infection will be treated with specific antibiotics depending on the blood culture. International Normalized Ratio \> 1.7 will be treated with either phytomenadion, Octaplex or fresh frozen plasma depending on the INR.

Umbilical hernia repair

Umbilical hernia repair PROCEDURE

A curved incision placed superiorly or inferiorly around the umbilicus. The umbilicus proper is retained in the skin flap. The blunt dissection is made to the hernia sac. The neck of the herniated sac is then dissected from adjacent tissues by a combination of blunt and sharp dissection. The edges of the fascial defect are measured and the fascial defect is closed with a non-absorbable running suture 2-0. A fitted lightweight polypropylene mesh is placed in an onlay fashion and fixed with 4-8 single non-absorbable sutures in the corners and at the midline, with a mesh overlap of at least 4 cm. The umbilicus is re-inserted with a single knot absorbable suture 3-0. Hemostasis is ensured. Skin closure is performed with Nylon suture 3-0. 20 ml bupivacaine 0.5% is injected to the fascia for early pain control.

Umbilical hernia repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all the following criteria to be eligible to enrol in the study:
• Age ≥18 years and ≤80 years
• ASA I-III
• Patients with a diagnosis of liver cirrhosis
• Patients with a diagnosis of umbilical hernia (primary or recurrent umbilical hernia)
• Hernia defect size 0,5 cm - 6 cm, only one defect
• Patients who have given written informed consent to participate in the study after having understood this

You may not qualify if:

• Patients who cannot cooperate with the trial.
• Patients who cannot read and understand Danish.
• Alcohol- and/or drug abuse - to the discretion of the investigator.
• Fascial gap \> 6 cm
• Umbilical hernia repair secondary to another procedure
• Patients in dialysis
• Patients who meet one or more of following criteria on procedure day will not undergo surgery, but can undergo surgery at a later date if none of the criteria are fulfilled:
• ASA IV
• Culture verified infection within two weeks prior to umbilical hernia repair
• Anemia (Hgb \< 5?)
• International Normalized Ratio \> 1.7
• Thrombocytopenia (\<100 mill/mL)
• Large amount of ascitic fluid
• If the operation is considered too risky by any investigator, a patient can always be excluded from surgical intervention based on individual assessment.
• Patients presenting with complicated umbilical hernia (incarceration, rupture, strangulation or ulceration) and the need for acute surgical intervention.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

MeSH Terms

Conditions

Fibrosis; Hernia, Umbilical

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Christian Snitkjær, M.B.

CONTACT

23670279; christian_snit@hotmail.com

Mette W. Willaume, M.D.

CONTACT

26288934; mette.willaume@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 29, 2020
• Study Start: August 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share