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

NCT06476054 | Recruiting

• 1 other identifier: 2453
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystitis, Acute

Keywords

Cholecystitis; Acute Cholecystitis; percutaneous drainage; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• recurrence tax of cholecystitis

  % of recurrence of cholecystitis after cholecystostomy in acute cholecystitis

  6 months after cholecystostomy

Secondary Outcomes (6)

• Patient demographics

  pre-operative and surgery day

• Pre-operative patient comorbidities

  pre-operative and surgery day

• Collection of pre-operative patient treatment (includes antibiotic prophylaxis)

  pre-operative and surgery day

• Surgery details

  pre-operative and surgery day

• Post-operative patient morbidity

  30 and 90 days post-surgery

Study Arms (2)

early interval

OTHER

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.

Procedure: Optimal timing for laparoscopic cholecystectomy

late interval

OTHER

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.

Procedure: Optimal timing for laparoscopic cholecystectomy

Interventions

Optimal timing for laparoscopic cholecystectomy PROCEDURE

To compare early and late cholecystectomy after cholecystostomy.

early interval; late interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years of age
• patients candidates for cholecystectomy, in scheduled surgery
• patients who accept participation and sign informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• 605387406 Vela Polanco, Dr

  Hospital Arnau de Vilanova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulthon Frank Vela Polanco, Dr

CONTACT

0034605387406; ffvela.lleida.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 26, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)