Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:

Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: Time to Change the Concept - A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736003
• Other study ID #: SVU/MED/SUR011/4/23/4/611
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.

Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.

Description:

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.

Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. ELC might be associated with a significant reduction in morbidity and mortality rates, comparable conversion rates, shorter hospital stays, lower costs, and higher patient satisfaction.

Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC. Additionally, 15% of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25% of patients require re-hospitalization for recurrent attacks of AC and biliary colic, biliary pancreatitis, cholangitis, and calcular obstructive jaundice during the interval waiting for the DLC. Furthermore, DLC has a higher cost and is time-consuming.

Prolonged LC (PLC) for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms, and this may be associated with increased perioperative complications and conversion rate. On the contrary, others believed that hyperemia and edema may help the dissection. All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms.

More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms. The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset,

2. American Society of Anesthesiologists (ASA) scores I - III,

3. Aged 20-70 years,

4. Agreement to complete the study

Exclusion Criteria:

1. Gallbladder polyp,

2. common bile duct stones,

3. acute biliary pancreatitis,

4. cholangitis,

5. perforated cholecystitis,

6. biliary peritonitis,

7. pregnancy

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy
Removal of gallbladder laparoscopically

Locations

Country	Name	City	State
Egypt	Mohammed Ahmed Omar	Luxor

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall morbidity	The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications	30 days
Secondary	Morbidity	All intra and postoperative complications	30 days
Secondary	Mortality	Death	30 days
Secondary	Total length of hospital saty	Duration of hospitalization	3 years
Secondary	Total Cost	The total cost includes the surgical and medical costs	3 years
Secondary	Total antibiotic duration	Duration of antibiotic therapy	3 years
Secondary	conversion rate	conversion from laparoscopic cholecystectomy to open cholecystectomy	3 years
Secondary	Operative time	duration from first trocar incision to last stitch	3 hours
Secondary	Lost days of work	Lost days of work	3 years