Optimal Timing for Laparoscopic Cholecystectomy After Percutaneous Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients over 18 years of age

• patients candidates for cholecystectomy, in scheduled surgery

• patients who accept participation and sign informed consent form

Locations
Other Locations
Spain
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Contact Information
Primary
Fulthon Frank Vela Polanco, Dr
ffvela.lleida.ics@gencat.cat
0034605387406
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 146
Treatments
Other: early interval
Both arms involve interventions, but participants in the early interval arm will undergo treatment (laparoscopic cholecystectomy) within 2 weeks after diagnosis, preferably within 10 days after the onset of symptoms of acute cholecystitis.
Other: late interval
Both arms involve interventions, but participants in the late interval arm will undergo treatment (laparoscopic cholecystectomy) after the 6th week of diagnosis, ideally between week 6 and week 8 following the diagnosis of acute cholecystitis.
Sponsors
Leads: Hospital Arnau de Vilanova

This content was sourced from clinicaltrials.gov