Evaluation of quality of life and resoration of function after bile duct injury.
ID
Source
Brief title
Condition
- Gallbladder disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life
Funtional outcome
Secondary outcome
Stenosis bile duct
Background summary
The incidence of bile injury after cholectstectomy is <2%. The treatment of the
injury depends on the type and time of diagnosis of the injury. If detected
peroperatively low morbidity and mortality rates have been reported. However if
the diagnosis is made postoperatively there is significant morbidity and
mortality.
A number of studies have researched the functional outcome and quality of life
after bile duct injury. However these studies were mainly conducted in referral
centres that specialise in HPB-surgery. Therefor a selectionbias exsist. Also
most studies were conducted a decenia ago when endoscopic treatment was not
available is all hospitals. The currenct study is conducted is a high volume
hospital. Therfor it is possible to select a relevant group of patients over a
relative short period of time (2003-2006) with treatment of bile duct injury
performed on modern standards.
Since most patients have been discharged from further follow up and no
intervention has been planned only studies that are a minimal burden to the
patient have been selected, ie bloodanalysis and ultrasound.
Study objective
Evaluation of quality of life and resoration of function after bile duct
injury.
Study design
Patient groups are selected from a historical database. Type of operation, type
of injury and type of reconstruction will we analysed retrospectively. All
other data will be collected prospectively.
Studies planned:
Ultrasound liver en bile duct
Blood analysis
Quality of life: SF-36 and GI0QLI questionnaire
Study burden and risks
Burden only in time. Minimal invasive studies have been selected: blood
analysis (1x) and abdominal ultrasound.
posbus 4446
6401 CX Heerlen
Nederland
posbus 4446
6401 CX Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
Basicgroup: bile duct injury after cholecystectomy
Controlgroup: uncomplicated cholecystectomy
Exclusion criteria
laparotomy for different cause
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17449.096.07 |