Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT05736003
• Lead Sponsor: South Valley University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-03
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed laparoscpic cholecystectomy	Laparoscopic cholecystectomy	Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms
Prolonged laparoscpic cholecystectomy	Laparoscopic cholecystectomy	Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms

Primary Outcome Measures

Name	Time	Method
Overall morbidity	30 days	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

Secondary Outcome Measures

Name	Time	Method
conversion rate	3 years	conversion from laparoscopic cholecystectomy to open cholecystectomy
Morbidity	30 days	All intra and postoperative complications
Operative time	3 hours	duration from first trocar incision to last stitch
Total Cost	3 years	The total cost includes the surgical and medical costs
Mortality	30 days	Death
Total antibiotic duration	3 years	Duration of antibiotic therapy
Total length of hospital saty	3 years	Duration of hospitalization
Lost days of work	3 years	Lost days of work

Trial Locations

Locations (1)

Mohammed Ahmed Omar; 🇪🇬 Luxor, Egypt