Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549881
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Emergent Laparoscopic Cholecystectomy With ICG Cholangiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green ICG Fluorescence a Single Center Experience
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELG-ICGC
Brief Summary:
A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green ICG fluorescence The patients were recruited in PUMCH emergency department from 2023 to 2024
Detailed Description:
Acute calculous cholecystitis typically occurs in patients with gallstones accounts for 90 to 95 of acute cholecystitis Emergent laparscopic cholecystectomy ELC is the major treatment option Traditionally the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms However with the development of surgical techniques nowadays ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring Comparing to delayed laparscopic cholecystectomy DLC ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours Post-operative complications for both DLC and ELC include bile leaks intestinal obstruction ascites intraperitoneal hemorrhage would bleeding and hematoma wound infection and calculus remaining Most of them associate with intraoperative procedures Laparoscopic cholecystectomy guided by indocyanine green ICG fluorescence comparing to conventional laparscopic procedures can help the surgeons to identify bile tracts and therefore may reduce the complications Therefore we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG
The surgical outcomes are evaluated by both intraoperative events and postoperative events Intraoperative events contain the following items 1 incidence of intraoperative accidental bile tract injury 2 intraoperative bleeding volume 3 operation time Postoperative events contain the following items 1 incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay 2 duration of postoperative hospital stay The economic effectiveness is evaluated by cost of hospital stay
The surgical outcomes are evaluated by both intraoperative events and postoperative events Intraoperative events contain the following items 1 incidence of intraoperative accidental bile tract injury 2 intraoperative bleeding volume 3 operation time Postoperative events contain the following items 1 incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay 2 duration of postoperative hospital stay The economic effectiveness is evaluated by cost of hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None