Randomised blind single centre study on morbidity and cost-effectiveness of two types of surgery for cholecystectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67485658

Enrollment

240

Registered

2006-01-26

Start date

2001-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Symptomatic cholecystolithiasis Nutritional, Metabolic, Endocrine Symptomatic cholecystolithiasis

Interventions

Small-incision versus laparoscopic cholecystectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic cholecystolithiasis 2. Older than 18 years 3. Reasonable to good health as classified by the American Society of Anesthesiologists (ASA) grade I - II 4. Knowledge of the Dutch language 5. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Choledocholithiasis 2. Cholangitis 3. Acute cholecystitis 4. Known pregnancy 5. Moderate to severe systemic disease (ASA III or higher) 6. Previous upper abdominal surgery (which would exclude the patient from laparoscopic cholecystectomy) 7. Psychiatric disease 8. History of abdominal malignancy

Design outcomes

Primary

Measure	Time frame
1. Mortality 2. Complications 3. Costs	—

Secondary

Measure	Time frame
1. Pulmonary function 2. Health-related quality of life 3. Convalescence (return to work)	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026