Skip to main content
OpenTrials
Completed

NCT Number: NCT05736003

Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed Ahmed Omar

Luxor, 83523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset,
  • American Society of Anesthesiologists (ASA) scores I - III,
  • Aged 20-70 years,
  • Agreement to complete the study

Exclusion criteria

  • Gallbladder polyp,
  • common bile duct stones,
  • acute biliary pancreatitis,
  • cholangitis,
  • perforated cholecystitis,
  • biliary peritonitis,
  • pregnancy

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Removal of gallbladder laparoscopically

Primary outcomes

  1. Overall morbidity

    Time frame: 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 outcomes

  1. Morbidity

    Time frame: 30 days

    All intra and postoperative complications

  2. Mortality

    Time frame: 30 days

    Death

  3. Total length of hospital saty

    Time frame: 3 years

    Duration of hospitalization

  4. Total Cost

    Time frame: 3 years

    The total cost includes the surgical and medical costs

  5. Total antibiotic duration

    Time frame: 3 years

    Duration of antibiotic therapy

  6. conversion rate

    Time frame: 3 years

    conversion from laparoscopic cholecystectomy to open cholecystectomy

  7. Operative time

    Time frame: 3 hours

    duration from first trocar incision to last stitch

  8. Lost days of work

    Time frame: 3 years

    Lost days of work

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.