Cirrhosis, Umbilical HerniaNCT04687579
Elective Umbilical Hernia Repair in Patients With Cirrhosis
A study testing Screening, Preoperative optimization and Umbilical hernia repair in people with Cirrhosis, Umbilical Hernia, run by Hvidovre University Hospital.
Trial 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 %. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Umbilical Hernia
- What is being tested?
- Screening, Preoperative optimization and Umbilical hernia repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Elective Umbilical Hernia Repair in Patients With Cirrhosis - a Prospective, Controlled Interventional Study
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
- Being tested
- Screening, Preoperative optimization, Umbilical hernia repair
- Medical subject headings
- Fibrosis, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
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.
Preoperative optimizationProcedure or surgery
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 repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical hernia repair | Experimental | Patients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions. Receives: 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. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after umbilical hernia repair and/or inclusion
Secondary outcomes (1)
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.
Measured: 6 months after umbilical hernia repair and/or inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Aug 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, Umbilical HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Snitkjær, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687579
- Sponsor's protocol ID
- HEROIC21
- Status last verified
- Apr 2021
- First submitted
- 21 Dec 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective Umbilical Hernia Repair in Patients With Cirrhosis - a Prospective, Controlled Interventional Study
- ClinicalTrials.gov ID
- NCT04687579
- Acronym / sponsor ID
- HEROIC21
- Conditions
- Cirrhosis, Umbilical Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical hernia repair | Experimental | Other: Screening, Procedure: Preoperative optimization, Procedure: Umbilical hernia repairPatients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions. |
| Watchful waiting | Other | Other: ScreeningPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningScreening: 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. | Other | Umbilical hernia repair, Watchful waiting |
| Preoperative optimizationAscites 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. | Procedure or surgery | Umbilical hernia repair |
| Umbilical hernia repairA 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. | Procedure or surgery | Umbilical hernia repair |
Primary outcome
Serious Adverse Events
Time frame: 6 months after umbilical hernia repair and/or inclusion
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
1 secondary outcome
Adverse Events
Time frame: 6 months after umbilical hernia repair and/or inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, Preoperative optimization and Umbilical hernia repair in people with Cirrhosis, Umbilical Hernia, run by Hvidovre University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Snitkjær, M.B. (23670279, christian_snit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 6 months after umbilical hernia repair and/or inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.