Acute Cholecystitis
Conditions
Keywords
Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy
Brief summary
Objectives: To compare the safety of early (≤72h) versus late (\>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC). Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack. Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.
Interventions
PROCEDUREEarly laparoscopic cholecystectomy
within 72h from symptom onset
PROCEDURELate laparoscopic cholecystectomy
after 72h up to seven days from symptom onset
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with AC within seven days from symptom onset * American Society of Anesthesiologist (ASA) physical status ≤ II * Age from 21 to 60 years
Exclusion criteria
* Patients with ASA physical status \> II * Age \< 21 years or \> 60 years * Child classification B or C * Choledocholithiasis * Acute pancreatitis * Severe sepsis * Gallbladder perforation * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants and Rate of Post-operative complications | 30 days post-operatively | Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Operative duration (hours) (mean±SD) | from surgical incision till suture closure | Mean and Standard deviation of Operative duration (hours) |
| Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD) | from surgical incision till suture closure | Mean and Standard deviation of Intra-operative blood loss (ml) |
| Number of participants and Rate of Conversion to open cholecystectomy | from the start till the end of surgical procedure | Number of participants and Rate of Conversion to open cholecystectomy |
| Mean and Standard deviation of Length of hospital stay (days) (mean±SD) | from hospital admission till home discharge within 30 days | Mean and Standard deviation of Length of hospital stay (days) |
Countries
Egypt
Outcome results
None listed