An interventional study of Screening and Preoperative optimization in Cirrhosis, Umbilical Hernia, sponsored by Hvidovre University Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's planned enrollment of 51 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Compared within Hernia, Umbilical, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet all the following criteria to be eligible to enrol in the study:
Exclusion criteria Patients who meet one or more of the following criteria are not eligible to be enrolled in this study
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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
Time frame: 6 months after umbilical hernia repair and/or inclusion
Adverse Events
1. A new event which was not pre-existing before intervention. 2. A pre-existing event which recurs with increased intensity or increased frequency in the follow-up period. 3. An event which is present at the time of intervention which is exacerbated following initial intervention.
Time frame: 6 months after umbilical hernia repair and/or inclusion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2021; primary completion for Sep 2023, 25 months later.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 25 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Hvidovre University Hospital →