Umbilical HerniaPhase 3CRUCIALNCT01421550
Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis
A Phase 3 study testing Conservative treatment and Surgical repair in people with Umbilical Hernia and Liver Cirrhosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia, Liver Cirrhosis, Ascites
- What is being tested?
- Conservative treatment and Surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Umbilical hernia
- Liver cirrhosis
- Ascites (US proven)
- Age ≥ 18 years
- Signed Informed consent
Who cannot join
- Recurrent umbilical hernia
- Midline laparotomy in medical history
- ASA1 score IV or above
- Incarcerated hernia related emergency procedures
- Patent umbilical vein; >5mm
- Expected time to Ltx <3 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015CE
B. de Goede, Msc
H.H. Eker, MD
About this study
Official title: Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial
The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.
The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.
- Conditions
- Umbilical Hernia, Liver Cirrhosis, Ascites
- Being tested
- Conservative treatment, Surgical repair
- Keywords
- umbilical, hernia, cirrhosis, ascites, conservative, surgery, optimal management
- Medical subject headings
- Hernia, Umbilical, Liver Cirrhosis, Ascites, Hernia, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
Surgical repairProcedure or surgery
Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward. Receives: Procedure: Conservative treatment |
| Surgical repair | Active comparator | Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up. Receives: Procedure: Surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery
Measured: 2 years
Secondary outcomes (5)
Recurrence
Measured: 2 years
Mortality
Measured: 2 years
Length of hospital stay
Measured: 3 months
Quality of life
Measured: 2 years
Cost effectiveness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasan eker, Erasmus Medical Center
- Investigators
- G Kazemier, MD, PhD, Principal investigator, Erasmus Medical CenterJ.F. Lange, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421550
- Sponsor's protocol ID
- CRUCIAL trial
- Acronym
- CRUCIAL
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Goede B, van Rooijen MMJ, van Kempen BJH, Polak WG, de Man RA, Taimr P, Lange JF, Metselaar HJ, Kazemier G. Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial). Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.
PubMed 33237442
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01421550
- Acronym / sponsor ID
- CRUCIAL / CRUCIAL trial
- Conditions
- Umbilical Hernia, Liver Cirrhosis, Ascites
- Keywords
- umbilical, hernia, cirrhosis, ascites, conservative, surgery, optimal management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Aug 2011 (estimated)
- 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.
The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.
The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Procedure: Conservative treatmentPatients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward. |
| Surgical repair | Active comparator | Procedure: Surgical repairPatients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary Umbilical hernia
- Liver cirrhosis
- Ascites (US proven)
- Age ≥ 18 years
- Signed Informed consent
Key exclusion criteria (6 listed)
- Recurrent umbilical hernia
- Midline laparotomy in medical history
- ASA1 score IV or above
- Incarcerated hernia related emergency procedures
- Patent umbilical vein; >5mm
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 |
|---|---|---|
| Conservative treatmentPatients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward. | Procedure or surgery | Conservative treatment |
| Surgical repairPatients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up. | Procedure or surgery | Surgical repair |
Primary outcome
complications
Time frame: 2 years
The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery
5 secondary outcomes
Recurrence
Time frame: 2 years
Mortality
Time frame: 2 years
Length of hospital stay
Time frame: 3 months
Quality of life
Time frame: 2 years
Cost effectiveness
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Derived from this study: PubMed 33237442de Goede B, van Rooijen MMJ, van Kempen BJH, Polak WG, de Man RA, Taimr P, Lange JF, Metselaar HJ, Kazemier G. Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial). Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.
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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.
G Kazemier, MD, PhD principal investigator
Erasmus Medical Center
J.F. Lange, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conservative treatment and Surgical repair in people with Umbilical Hernia and Liver Cirrhosis, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 6 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 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 B. de Goede, Msc (+31 6280661102, b.degoede@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421550, which also lists 1 linked publication.
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 23 Aug 2011.