Optimal Timing for Laparoscopic Cholecystectomy After Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Arnau de Vilanova

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Optimal timing for laparoscopic cholecystectomy

    Procedure/Surgery

    To compare early and late cholecystectomy after cholecystostomy.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: early intervalOther 1 intervention
Group B: late intervalOther 1 intervention

Trial outcomes

Primary outcomes

1

recurrence tax of cholecystitis

% of recurrence of cholecystitis after cholecystostomy in acute cholecystitis

Time frame
6 months after cholecystostomy

Secondary outcomes

1

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.

Time frame
pre-operative and surgery day
2

Pre-operative patient comorbidities

Data tracking related to patient previous comorbidities to evaluate if it affects to the recurrence tax.

Time frame
pre-operative and surgery day
3

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.

Time frame
pre-operative and surgery day
4

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.

Time frame
pre-operative and surgery day

Other outcomes

Sponsors and contacts

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