Back to results

Elective Umbilical Hernia Repair in Patients With Cirrhosis

Primary Purpose

Cirrhosis, Umbilical Hernia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Screening

Preoperative optimization

Umbilical hernia repair

About this trial

This is an interventional treatment trial for Cirrhosis, Umbilical Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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

Exclusion criteria Patients who meet one or more of the following criteria are not eligible to be enrolled in this study

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
If a patient withdraws his/her inclusion consent
Patients in dialysis

Exclusion from operation

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.
Patients with BMI > 35 will not undergo surgery. If the patient during inclusion period does not fulfil this criterion (BMI < 35), other exclusion criteria and the rest of inclusion criteria are met then the patient can undergo surgery.
Thrombolysis within 3 months from umbilical hernia repair

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Umbilical hernia repair

Watchful waiting

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Serious Adverse Events

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

Secondary Outcome Measures

Adverse Events

A new event which was not pre-existing before intervention. A pre-existing event which recurs with increased intensity or increased frequency in the follow-up period. An event which is present at the time of intervention which is exacerbated following initial intervention.

Full Information

NCT ID

NCT04687579

First Posted

December 21, 2020

Last Updated

April 29, 2021

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04687579

Brief Title

Elective Umbilical Hernia Repair in Patients With Cirrhosis

Official Title

Elective Umbilical Hernia Repair in Patients With Cirrhosis - a Prospective, Controlled Interventional Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2021 (Anticipated)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Umbilical Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Umbilical hernia repair

Arm Type

Experimental

Arm Description

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

Arm Title

Watchful waiting

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Screening

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Preoperative optimization

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Umbilical hernia repair

Intervention Description

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.

Primary Outcome Measure Information:

Title

Serious Adverse Events

Description

Time Frame

6 months after umbilical hernia repair and/or inclusion

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Time Frame

6 months after umbilical hernia repair and/or inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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 Exclusion criteria Patients who meet one or more of the following criteria are not eligible to be enrolled in this study 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 If a patient withdraws his/her inclusion consent Patients in dialysis Exclusion from operation 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. Patients with BMI > 35 will not undergo surgery. If the patient during inclusion period does not fulfil this criterion (BMI < 35), other exclusion criteria and the rest of inclusion criteria are met then the patient can undergo surgery. Thrombolysis within 3 months from umbilical hernia repair

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Snitkjær, M.B.

Phone

23670279

christian_snit@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mette W. Willaume, M.D.

Phone

26288934

mette.willaume@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Elective Umbilical Hernia Repair in Patients With Cirrhosis

We'll reach out to this number within 24 hrs