About this trial
Percutaneous drainage in acute cholecystitis has been recommended by the recent update of the Tokyo Guidelines for patients with grade II and III disease who are unable to undergo surgical treatment due to their condition or associated comorbidities.
There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage, so a consensus has not been reached. The grade III stage generates the most controversy; after percutaneous drainage, delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology.
The economic impact, including the number of readmissions, increased length of stay, and associated morbidity and mortality, generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients over 18 years of age
patients candidates for cholecystectomy, in scheduled surgery
patients who accept participation and sign informed consent form
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Optimal timing for laparoscopic cholecystectomy
Procedure/SurgeryTo compare early and late cholecystectomy after cholecystostomy.
Treatment groups
Trial outcomes
Primary outcomes
recurrence tax of cholecystitis
% of recurrence of cholecystitis after cholecystostomy in acute cholecystitis
Secondary outcomes
Patient demographics
Data tracking related to patient demographics to evaluate if it affects to the recurrence tax. Age (years), BMI in kg/m\^2, Charlson and ASA classification.
Pre-operative patient comorbidities
Data tracking related to patient previous comorbidities to evaluate if it affects to the recurrence tax.
Collection of pre-operative patient treatment (includes antibiotic prophylaxis)
Data tracking related to patient previous treatments or prophylaxis to evaluate if it affects to the recurrence tax.
Surgery details
Data tracking related to patient surgery issues to evaluate if it affects to the recurrence tax. Presence of: Technique difficulties, description of intra-operative complications.
Sponsors and contacts
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