Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624841
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2020-10-30
Brief Title:
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective randomized trial is to study the role of Indocyanine green ICG to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis
Detailed Description:
After informing about the study and obtaining consent to participate patients who are diagnosed with Acute Cholecystitis and posted for emergency Laparoscopic Cholecystectomy will be randomly assigned to receive either ICG or not as a method to identify the Critical View of Safety during the operation
The primary outcome is whether there was a precise and satisfactory visualization of the junction between the cystic duct the common hepatic duct and the common bile duct by indocyanine green compared to the control group The time taken to achieve this will be measured in minutes from video recordings of the laparoscopic surgery The process will be further assessed by a surgeons satisfaction score
The expected duration of the study will be 12 months involving a total of 80 patients randomized into two groups- 40 patients in the intervention group and 40 patients in the control group
The expected outcome of the study is that ICG is more effective than the control group in providing precise and satisfactory visualization of Critical View of Safety and takes less time We predict the surgeons to be equally or more satisfied with ICG compared to control
The primary outcome is whether there was a precise and satisfactory visualization of the junction between the cystic duct the common hepatic duct and the common bile duct by indocyanine green compared to the control group The time taken to achieve this will be measured in minutes from video recordings of the laparoscopic surgery The process will be further assessed by a surgeons satisfaction score
The expected duration of the study will be 12 months involving a total of 80 patients randomized into two groups- 40 patients in the intervention group and 40 patients in the control group
The expected outcome of the study is that ICG is more effective than the control group in providing precise and satisfactory visualization of Critical View of Safety and takes less time We predict the surgeons to be equally or more satisfied with ICG compared to control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1256-1361 | OTHER | WHO International Clinical Trials Registry | None |