Bile duct damage Bile duct injury
Conditions
Interventions
One group receives the drained bile to a maximum of 900 ml/day in three equal
portions. The control group receives no suppletion of the drained bile.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Older than 18 years of age -Total or partial iatrogenic damage of the biliary tract after cholecystectomy, leading to biliary drainage and subsequent need for surgical reconstruction. -Patients are included in the study after signing informed consent.
Exclusion criteria
Exclusion criteria: -Malignancies of the biliary tract -Malignancies of the pancreas -Unwillingness to receive bile restitution -Cholangitis (bacterial contamination of the bile) -Insufficient bile-drain production
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight expressed in Kilogrammes. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Body Mass Index (BMI), - Body composition expressed in fat-mass, lean body mass, handgrip strength and mid-arm muscular circumference (MAMC), - Nutritional intake expressed in macronutrients, micronutrients and fluids, - Stability of Cl, K, Na, Ca, Fe and cholesterol plasma values. - Quality of life measured by SF-36 and GiQLi, - Incidence of nausea, intestinal cramps, intestinal pain and diarrhoea and sepsis. | — |
Countries
Netherlands
Outcome results
None listed