Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.

Cholecystitis, Acute Clinical Trial

Official title:

Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05502744
• Other study ID #: Still not known
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 14, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

Description:

Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 14, 2023
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. age less than 70 years.

2. fit for surgery.

Exclusion Criteria:

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.

2. Patients with Pancreatitis .

3. Patients with previous upper abdominal surgery.

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Emergencies

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.	Collect results and see.	Intraoperative time
Secondary	Incidence of postoperative complications in urgent versus elective lap cholecystectomy.	Collect results and see.	6 months.