Trials / Unknown
UnknownNCT04624841
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Hamad Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Indocyanine Green | 2.5-7.5 mg (0.05 mg/kg) injection |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2021-12-31
- Completion
- 2022-01-15
- First posted
- 2020-11-12
- Last updated
- 2020-12-16
Locations
1 site across 1 country: Qatar
Source: ClinicalTrials.gov record NCT04624841. Inclusion in this directory is not an endorsement.