Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis
Conditions
Keywords
Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography
Brief summary
This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy
Detailed description
A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.
Interventions
PROCEDUREIndocyanine Green Fluorescent Laparoscopic Cholangiography
Indocyanine Green Fluorescent Cholangiography
PROCEDUREWhite Light
Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2 arms, randomized, double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adults (from 18 to 75 years old) * suffering from a gall bladder disease * with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis) * accepted to participate in the study.
Exclusion criteria
* Patients with history of previous biliary surgery * Patients with abdominal malignancy * Patients with advanced chronic liver disease * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual identification of the biliary tree | during the procedure | To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC. |
| Visual identification of the cystic artery | during the procedure | To measure the % of patients in which investigators can identify visually the cystic artery, during LC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare blood loss | during the procedure | To compare the operative blood loss (in cc) |
| Visual identification of injuries | during and imediatly after the procedure (24 hours) | To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures. |
| Percentage of patients of ICG adverse reactions | Within 24 hour of the procedure | To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..) |
| Compare blood loss in cc | during the procedure | To compare the blood loss (in cc) between the two groups. |
| Compare operative time | during the procedure | To compare the operative time in (minutes) |
Countries
Egypt
Outcome results
None listed