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
  Purpose

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.


Condition Intervention Phase
Umbilical Hernia
Liver Cirrhosis
Ascites
Procedure: Conservative treatment
Procedure: Surgical repair
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conservative treatment
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
Procedure: Conservative treatment
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421550

Contacts
Contact: B. de Goede, Msc +31 6280661102 b.degoede@erasmusmc.nl
Contact: H.H. Eker, MD +31 628925554 h.eker@erasmusmc.nl

Locations
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015CE
Contact: B. de Goede, Msc         
Contact: H.H. Eker, MD         
Principal Investigator: G. Kazemier, MD, PhD         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: G Kazemier, MD, PhD Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
  More Information

No publications provided

Responsible Party: hasan eker, Dr. G. Kazemier, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01421550     History of Changes
Other Study ID Numbers: CRUCIAL trial
Study First Received: August 19, 2011
Last Updated: August 22, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
umbilical
hernia
cirrhosis
ascites
conservative
surgery
optimal management

Additional relevant MeSH terms:
Ascites
Hernia
Hernia, Umbilical
Liver Cirrhosis
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014