Clinical trial NCT05736003: Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis
Official title: Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: Time to Change the Concept - A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 437
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Total length of hospital saty
timeFrame: 3 years
measure: Total Cost
timeFrame: 3 years
measure: Total antibiotic duration
timeFrame: 3 years
measure: conversion rate
timeFrame: 3 years
measure: Operative time
timeFrame: 3 hours
measure: Lost days of work
timeFrame: 3 years
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: Mohammed Ahmed Omar
Study officials:
affiliation: General Surgery Department, Faculty of Medicine, South Valley University
name: Mohammed A Omar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: