MedPath

Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Not Applicable
Completed
Conditions
Acute Calculous Cholecystitis
Interventions
Procedure: Laparoscopic cholecystectomy
Registration Number
NCT03477253
Lead Sponsor
Assiut University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LC within 72 hours of disease onsetLaparoscopic cholecystectomyImmediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients
LC after 72 hours of disease onsetLaparoscopic cholecystectomyLate laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients
Primary Outcome Measures
NameTimeMethod
Comparison between early and late laparoscopic cholecystectomy regarding Operation timeintra-operative

comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes

Duration of postoperative hospital staywithin 2 weeks post-operative

comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital

Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operationintra-operative

comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy

comparison between early and late laparoscopic cholecystectomy regarding post operative painwithin 1month post operative

comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics

Secondary Outcome Measures
NameTimeMethod
comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding7 days postoperative

compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding

presence of any wound complication by examining the woundwithin 10 days post-operative

comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative

comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakagefirst 72 hours post-operative

compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assiut, Egypt

© Copyright 2025. All Rights Reserved by MedPath