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This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR/ICG Arm | Experimental | Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy |
|
| WL Arm | Active Comparator | Conventional white light was used for Laparoscopic Cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green Fluorescent Laparoscopic Cholangiography | Procedure | Indocyanine Green Fluorescent Cholangiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual identification of the biliary tree | 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. | during the procedure |
| Visual identification of the cystic artery | To measure the % of patients in which investigators can identify visually the cystic artery, during LC. | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Visual identification of injuries | To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures. | during and imediatly after the procedure (24 hours) |
| Compare operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Abd-erRazik, MD | Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals - AUSH | Cairo | Egypt |
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2 arms, randomized, double blinded
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| White Light | Procedure | Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light |
|
|
To compare the operative time in (minutes)
| during the procedure |
| Compare blood loss | To compare the operative blood loss (in cc) | during the procedure |
| Compare blood loss in cc | To compare the blood loss (in cc) between the two groups. | during the procedure |
| Percentage of patients of ICG adverse reactions | To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..) | Within 24 hour of the procedure |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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