the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!

Acute Cholecystitis Clinical Trial

Official title:

the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459323
• Other study ID #: Cholecystectomy timing
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2025
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.

Description:

Laparoscopic cholecystectomy (LC) is the mainstay treatment of acute cholecystitis. However, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of AC progresses. New Guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. Hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients Studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the Calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for LC performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. After 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.Studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. However, other studies did not report any difference in operation times between both groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with acute cholecystitis within and after 72 hours.

2. Patients over 18 years.

3. Patients with no common bile duct stones based on imaging and biochemical criteria

4. Fit for surgery.

Exclusion Criteria:

1. Patients not fit for surgery

2. Patients with Pancreatitis.

3. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile duct injury , intraoperative bleeding and operative time	Evaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end	One week

External Links

•   Navez, B., Ungureanu, F., Michiels, M. et al. Surgical management of acute cholecystitis: results of a 2-year prospective multicenter survey in Belgium. Surg Endosc 26, 2436-2445 (2012).