A randomised controlled trial comparing surgery with watchful waiting for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones

Not Applicable

Completed

• Conditions: Gallstones; Digestive System

• Registration Number: ISRCTN55215960
• Lead Sponsor: niversity of Aberdeen

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33766835/ (added 29/03/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38084426/ (added 18/12/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38943314/ (added 01/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-27
• Study Completion: 2021-12-01
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 436

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>The primary economic outcome measure will be incremental cost per QALY.