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

NCT01421550 | Unknown Phase 3 DMC

• 1 other identifier: CRUCIAL trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

umbilical; hernia; cirrhosis; ascites; conservative; surgery; optimal management

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (5)

• Recurrence

  2 years

• Mortality

  2 years

• Length of hospital stay

  3 months

• Quality of life

  2 years

• Cost effectiveness

  2 years

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.

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.

Procedure: Surgical repair

Interventions

Conservative treatment PROCEDURE

Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.

Conservative treatment

Surgical repair PROCEDURE

Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.

Surgical repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015CE, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 33237442 DERIVED

MeSH Terms

Conditions

Hernia, Umbilical; Liver Cirrhosis; Ascites; Hernia; Fibrosis

Interventions

Conservative Treatment; Wound Healing

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Regeneration; Biological Phenomena

Study Officials

• G Kazemier, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• J.F. Lange, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

B. de Goede, Msc

CONTACT

+31 6280661102; b.degoede@erasmusmc.nl

H.H. Eker, MD

CONTACT

+31 628925554; h.eker@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. G. Kazemier

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

NL (1)