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Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis (CRUCIAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Erasmus Medical Center
Sponsor:
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01421550
First received: August 19, 2011
Last updated: August 22, 2011
Last verified: August 2011

August 19, 2011
August 22, 2011
January 2011
December 2013   (final data collection date for primary outcome measure)
complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01421550 on ClinicalTrials.gov Archive Site
  • Recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Umbilical Hernia
  • Liver Cirrhosis
  • Ascites
  • Procedure: Conservative treatment
    Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
  • Procedure: Surgical repair
    Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
  • Active Comparator: Conservative treatment
    Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
    Intervention: Procedure: Conservative treatment
  • Active Comparator: Surgical repair
    Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
    Intervention: Procedure: Surgical repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary Umbilical hernia
  • Liver cirrhosis
  • Ascites (US proven)
  • Age ≥ 18 years
  • Signed Informed consent

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: B. de Goede, Msc +31 6280661102 b.degoede@erasmusmc.nl
Contact: H.H. Eker, MD +31 628925554 h.eker@erasmusmc.nl
Netherlands
 
NCT01421550
CRUCIAL trial
Yes
hasan eker, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Principal Investigator: G Kazemier, MD, PhD Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
Erasmus Medical Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP