The validatation a decision rule for the indication of gallbladder surgery in people with gallstones.

Standardized work-up for symptomatic cholecystolithiasis; a prospective multicenter study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24368

Enrollment

500

Registered

2018-06-12

Start date

2017-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated cholecystolithiasis Gallstones Cholecystectomy Post-cholecystectomy symptoms Ongecompliceerde cholecystolithiasis Galstenen Cholecystectomie Symptomen na cholecystectomie

Interventions

Questionnaires: EQ-5D Short Form - Health and Labour Questionnaire Izbicki Pain Score Gastro-Intestinal Quality of Life Index Gallstone Symptom List

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years of age or older, and - with ultrasonically proven, uncomplicated cholecystolithiasis, and - referred for surgical consultation

Exclusion criteria

Exclusion criteria: - History of complicated cholelithiasis (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) - Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses; - Mentally incompetent; - Insufficient knowledge of the Dutch language; - Known pregnancy

Design outcomes

Primary

Measure	Time frame
The predictive validity, external validity and the sensitivity and specificity of the decision rule with as outcome a pain-free patient after 6 months.	—

Secondary

Measure	Time frame
- The proportion of patients fulfilling 3 or more criteria of the decision rule and scheduled for cholecystectomy and the proportion in those not scheduled. - The proportion of patients fullfilling 3, 4 or 5 criteria of the decision rule, scheduled for cholecystectomy and pain-free. - The symptoms of patients at baseline prediciting to be painfree after cholecystectomy. - The proportion of patients with uncomplicated cholecystolithiasis and abdominal symptoms that has a BMI >25 and the proportion with BMI >30 - The difference in symptom change, after six months follow-up between the group of patients that received cholecystectomy and those without operation - Description of additional health care consumption in patients not scheduled for surgery, i.e. diagnostic tests and therapeutic interventions within six months of first outpatient clinic visit - Description of the aspect and wall thickness of the gallbladder wall at ultrasound - Description of the pathological report of the gallbladder (providing that the patient had an operation and pathological examination of the gallbladder is done)	—

Measure

Time frame

- The proportion of patients fulfilling 3 or more criteria of the decision rule and scheduled for cholecystectomy and the proportion in those not scheduled. - The proportion of patients fullfilling 3, 4 or 5 criteria of the decision rule, scheduled for cholecystectomy and pain-free. - The symptoms of patients at baseline prediciting to be painfree after cholecystectomy. - The proportion of patients with uncomplicated cholecystolithiasis and abdominal symptoms that has a BMI >25 and the proportion with BMI >30 - The difference in symptom change, after six months follow-up between the group of patients that received cholecystectomy and those without operation - Description of additional health care consumption in patients not scheduled for surgery, i.e. diagnostic tests and therapeutic interventions within six months of first outpatient clinic visit - Description of the aspect and wall thickness of the gallbladder wall at ultrasound - Description of the pathological report of the gallbladder (providing that the patient had an operation and pathological examination of the gallbladder is done)

—

Contacts

Public ContactCarmen Latenstein

Huispost 618, Postbus 9101

carmen.latenstein@radboudumc.nl06-19402554

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)