Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Assiut University

Status: Completed

Conditions: Acute Calculous Cholecystitis

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03477253

LC in management of ACC

Details and patient eligibility

About

This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

Full description

The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A & B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
2. Initial surgical management planned for immediate laparoscopic cholecystectomy.
3. Patients who are fit for laparoscopy and general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion criteria

1. Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
2. Patients with other associated abdominal pathology.
3. Patients with any previous abdominal surgery or any significant systemic disease.
4. Septic shock.
5. Pregnancy/ Breast-feeding mothers.
6. Participation in an additional drug or device study and inability to offer informed consent.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

LC within 72 hours of disease onset

Active Comparator group

Description:

Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients

Treatment:

Procedure: Laparoscopic cholecystectomy

LC after 72 hours of disease onset

Active Comparator group

Description:

Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients

Treatment:

Procedure: Laparoscopic cholecystectomy