Gallstones Digestive System
Conditions
Interventions
1. Laparoscopic cholecystectomy: the current standard surgical procedure for the management of symptomatic gallstone disease. The gall bladder is removed with the stones within it using keyhole techni
Sponsors
University of Aberdeen
Grampian Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All adult patients with confirmed gallstones electively referred to a secondary care setting for consultation. Clinical diagnosis of gallstone disease will be confirmed by imaging. Transabdominal ultrasonography is the standard imaging technique for the diagnosis of gallbladder stones, but diagnosis by any imaging technique is acceptable.
Exclusion criteria
Exclusion criteria: 1. Unable to consent 2. ASA III and above 3. Pregnancy 4. Previous open major upper abdominal surgery 5. Gallstones in common bile duct or evidence of previous choledocholithiasis 6. A history of acute pancreatitis 7. Abnormal liver function tests (with the exception of GGT <90u/L) 8. Evidence of empyema of the gallbladder 9. Perforated gallbladder 10. Haemolytic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary patient outcome measure will be quality of life as measured by area under the curve (AUC) at up to 18 months post-randomisation using the SF-36 bodily pain domain (AUC measures at 3, 9 and 18 months). The primary economic outcome measure will be incremental cost per QALY. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/07/2023: Measured at baseline, 3, 9, 12, 18 and 24 months: 1. Condition-specific quality of life (CSQ – The Otago gallstone condition-specific questionnaire) 2. SF-36 domains (excluding bodily pain domain) complications 3. Need for further treatment 4. Persistent symptoms 5. Healthcare resource use 6. Costs The AUC at up to 24 months post-randomisation for the SF-36 bodily pain domain will be reported. In addition, routinely collected national data on further surgery will be sought in the future to update longer-term estimates of cost-effectiveness. Previous secondary outcome measures as of 10/09/2021: Measured at baseline, 3, 9, 12 and 18 months: 1. Condition-specific quality of life (CSQ – The Otago gallstone condition-specific questionnaire) 2. SF-36 domains (excluding bodily pain domain) complications 3. Need for further treatment 4. Persistent symptoms 5. Healthcare resource use 6. Costs The AUC at up to 24 months post-randomisation for the SF-36 bodily pain domain will be reported. In addition, routinely collected national data on further surgery will be sought in the future to update longer-term estimates of cost-effectiveness. Previous secondary outcome measures: Measured at baseline, 3, 9, 12 and 18 months: 1. Condition-specific quality of life (CSQ – The Otago gallstone condition-specific questionnaire) 2. SF-36 domains (excluding bodily pain domain) complications 3. Need for further treatment 4. Persistent symptoms 5. Healthcare resource use 6. Costs In addition, routinely collected national data on further surgery will be sought in the future to update longer-term estimates of cost-effectiveness. | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKaren Innes
Outcome results
None listed