Impact of COVID-19 Pandemic on Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service
Evaluation of a Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service Pre-, Intra- and Post-COVID-19 Pandemic: a Retrospective Cohort Study
1 other identifier
observational
237
0 countries
N/A
Brief Summary
Choledocholithiasis is reported to be present in 15-20% of patients with symptomatic gallstones. The single-stage management consists of performing either laparoscopic common bile duct exploration (LCBDE) or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) at the same time as laparoscopic cholecystectomy (LC). Since the Coronavirus (COVID-19) pandemic, surgical practice has significantly been impacted. The pandemic has had ramifications on patient and staff safety, surgical techniques, minimally invasive procedures, theatre workflow, education and training. The investigators analysed a series of LCBDE procedures in our institution pre-, intra- and post-COVID-19 pandemic to assess the feasibility, efficacy and safety of this single-stage treatment approach following the pandemic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedMarch 27, 2026
March 1, 2026
7.8 years
May 13, 2025
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Intraoperative measures
Number of participants, size of choledochoscope used, rate of holmium laser lithotripsy use and stone clearance rates
90 days
Postoperative complications
Number of participants, number of complications (e.g. bile leak and pancreatitis), duration of hospital length of stay
90 days
Study Arms (3)
Pre-pandemic
April 2016 to March 2020 (48 months)
Intra-pandemic
March 2020 to December 2021 (22 months)
Post-pandemic/recovery period
January 2022 to February 2024 (26 months)
Interventions
Choledochotomy and transductal common bile duct exploration or transcystic choledochoscopy and common bile duct exploration
Eligibility Criteria
Patients that underwent the single-stage approach of LC + LCBDE for the management of choledocholithiasis, between April 2016 and February 2024. All patients were assessed with preoperative liver function tests (LFTs) and abdominal imaging such as ultrasound, computed tomography (CT) and/ or magnetic resonance cholangiopancreatography (MRCP).
You may qualify if:
- Patients that underwent single-stage LC + LCBDE for the management of choledocholithiasis with concomitant gallstones.
You may not qualify if:
- Patients that underwent LC only or LCBDE only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
May 15, 2025
Study Start
April 1, 2016
Primary Completion
February 1, 2024
Study Completion
May 1, 2025
Last Updated
March 27, 2026
Record last verified: 2026-03