Actively Recruiting
Optimal Timing for Laparoscopic Cholecystectomy After Percutaneous Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting: A Randomized Clinical Trial
Led by Hospital Arnau de Vilanova · Updated on 2024-06-28
146
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine the best timing for laparoscopic cholecystectomy (LC) after percutaneous cholecystostomy (PC) in patients with acute cholecystitis grades II and III who cannot undergo surgery immediately due to their condition or other health issues. The study addresses the uncertainty about whether early or delayed surgery reduces recurrence and complications, especially in severe cases, and also evaluates related costs and health impacts. Participants will be randomly assigned to one of two groups: an early surgery group receiving LC within 2 weeks of diagnosis (preferably within 10 days) and a delayed surgery group receiving LC after the 6th week (ideally between weeks 6 and 8). Before surgery, all will undergo imaging tests like MRCP or endoscopic ultrasound to check for bile duct stones and may receive antibiotics according to hospital protocols. The PC catheter will remain in place until surgery and be removed during the operation. During the study, researchers will collect detailed medical information including patient demographics, pre-existing conditions, treatment details, surgical techniques, complications, and recovery outcomes. They will measure the recurrence rate of cholecystitis six months after PC and monitor morbidity and mortality at 30 and 90 days post-surgery. Follow-up includes reviewing medical records and clinical notes to assess patient progress and safety throughout the trial period.
CONDITIONS
Brief Title
Optimal Timing for Laparoscopic Cholecystectomy After Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Candidates for scheduled laparoscopic cholecystectomy surgery
- Patients who accept participation and sign informed consent form
You will not qualify if you...
- Conditions that prevent proper following of treatment as determined by the principal investigator
- Morbidity related to the procedure that delays or makes treatment impossible
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks before surgery
Participants undergo preoperative imaging studies to rule out associated choledocholithiasis. If confirmed, preoperative ERCP is performed. Prophylactic antibiotics are given according to hospital protocol.
1 to 2 visits depending on imaging and procedures
Duration - Varies by group: Early (within 2 weeks) or Late (week 6 to 8)
Participants undergo laparoscopic cholecystectomy either early (within 2 weeks of diagnosis, preferably within 10 days) or delayed (from the 6th week, preferably between weeks 6 and 8). The PC catheter remains until surgery and is removed intraoperatively.
1 surgery visit (in-person)
Duration - 90 days post-surgery
Participants are monitored for post-operative morbidity and mortality, including complications and recovery assessments up to 90 days after surgery.
Approximately 3 follow-up visits within 90 days
Trial Site Locations
Total: 1 location
1
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
Research Team
F
Fulthon Frank Vela Polanco, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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