Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT ID: NCT05736003

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 437 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-01-30

Brief 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.

Detailed 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.

Conditions

Acute Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prolonged laparoscpic cholecystectomy

Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Removal of gallbladder laparoscopically

Delayed laparoscpic cholecystectomy

Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms

Group Type: ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Removal of gallbladder laparoscopically

Interventions

Laparoscopic cholecystectomy

Removal of gallbladder laparoscopically

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ahmed Omar, MD

Associate professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Omar, M.D.

Role: PRINCIPAL_INVESTIGATOR

General Surgery Department, Faculty of Medicine, South Valley University

Locations

Mohammed Ahmed Omar

Luxor, , Egypt

Countries

Egypt

Other Identifiers

SVU/MED/SUR011/4/23/4/611

Identifier Type: -

Identifier Source: org_study_id