Timing for Gallbladder Surgery After Drainage in Acute Cholecystitis
Optimal Timing for Laparoscopic Cholecystectomy After Percutaneous Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting: A Randomized Clinical Trial
NA · Hospital Arnau de Vilanova · NCT06476054
This study is testing whether having gallbladder surgery sooner or later after drainage helps people with acute cholecystitis recover better and have fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Arnau de Vilanova (other) |
| Locations | 1 site (Lleida) |
| Trial ID | NCT06476054 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal timing for laparoscopic cholecystectomy in patients who have undergone percutaneous cholecystostomy for acute cholecystitis. It will compare outcomes between early and late surgery to assess recurrence rates and associated morbidity and mortality. The study will involve multiple centers and will collect extensive pre-operative and post-operative data to ensure a comprehensive analysis. The recruitment period for participants is set for 18 months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for cholecystectomy following percutaneous drainage.
Not a fit: Patients with significant comorbidities that prevent proper follow-up or those who cannot undergo the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with acute cholecystitis.
How similar studies have performed: While there is limited high-quality evidence on this specific timing issue, similar studies have explored surgical timing in other contexts, indicating potential for impactful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients over 18 years of age * patients candidates for cholecystectomy, in scheduled surgery * patients who accept participation and sign informed consent form Exclusion Criteria: * According to the principal investigator criteria, for reasons that make it impossible to correctly follow the treatment. * Presence of morbidity associated with the procedure that delays or makes treatment impossible.
Where this trial is running
Lleida
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (RECRUITING)
Study contacts
- Principal investigator: 605387406 Vela Polanco, Dr — Hospital Arnau de Vilanova
- Study coordinator: Fulthon Frank Vela Polanco, Dr
- Email: ffvela.lleida.ics@gencat.cat
- Phone: 0034605387406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholecystitis, Acute, Cholecystitis, Acute Cholecystitis, percutaneous drainage, laparoscopic cholecystectomy