Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

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 Type: Interventional
• Enrollment (Actual): 437
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Luxor, Egypt, 83523
    • Mohammed Ahmed Omar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged laparoscpic cholecystectomy; Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms	Procedure: Laparoscopic cholecystectomy; Removal of gallbladder laparoscopically
Active Comparator: Delayed laparoscpic cholecystectomy; Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms	Procedure: Laparoscopic cholecystectomy; Removal of gallbladder laparoscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Mohammed A Omar, M.D., General Surgery Department, Faculty of Medicine, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: SVU/MED/SUR011/4/23/4/611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication
• IPD Sharing Time Frame: For 1 year
• IPD Sharing Access Criteria: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No