Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines

NCT04979936 | Completed

• 1 other identifier: 17/11
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare between early laparoscopic cholecystectomy versus percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy as regards the operative and postoperative complications

Conditions

Acute Cholecystitis; Empyema, Gallbladder

Keywords

moderate acute cholecystitis, percutaneous cholecystostomy

Outcome Measures

Primary Outcomes (2)

• operative difficulties as conversion, operative time, biliary injury

  as assessed by the main surgeon

  at the time of cholecysctomy

• postoperative complications

  as assessed by clavien dindo classification

  30 days after the operation

Study Arms (2)

early laparoscopic cholecystectomy

ACTIVE COMPARATOR

early laparoscopic cholecystectomy

Procedure: laparoscopic cholecystectomy

percutaneous cholecystostomy

ACTIVE COMPARATOR

percutaneous cholecystostomy first followed by delayed laparoscopic cholecystectomy

Procedure: percutaneous cholecystostomy

Interventions

laparoscopic cholecystectomy PROCEDURE

early laparoscopic cholecystectomy

percutaneous cholecystostomy PROCEDURE

percutaneous cholecystostomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with one of the criteria stated by grade II (moderate) Tokyo guidelines for acute cholecystitis who were managed either by early LC or by a bridging PC followed by delayed LC.

You may not qualify if:

• grade I or III acute cholecystitis
• common bile duct stones or jaundice,
• Liver cirrhosis,
• severe upper abdominal adhesions,
• acalculous cholecystitis
• major comorbidities in which laparoscopic surgery is contraindicated.
• those who followed a conservative treatment for acute cholecystitis

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Alexandria university

Alexandria, Egypt

Location

Faculty of Medicine

Alexandria, Egypt

Location

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

• HANY MK EL-HADDAD, professor

  alexandria university, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: July 28, 2021
• Study Start: January 1, 2016
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)