Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552949
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Cohort Study on Emergent Laparoscopic Cholecystectomy Guided by Indocyanine Green ICG Fluorescence Versus Conventional Laparoscopic Operation
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:
ELC-PUMCH
Brief Summary:
A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography ELC-ICGC versus conventional laparoscopic operation The patients were recruited in the Peking Union Medical Colleg Hospital emergency department from 1st August 2020 to 1st Feburary 2024 A database was prospectively established to collect related data The surgical outcomes of ELC-ICGC and conventional ElC will be compared
Detailed Description:
Acute calculous cholecystitis typically occurs in patients with gallstones accounts for 90 to 95 of acute cholecystitis Emergent laparoscopic 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 laparoscopic 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 Emergent laparoscopic cholecystectomy guided by indocyanine green ICG cholangiography ELC-ICGC comparing to conventional LC potentially can help the surgeons to identify bile tracts and therefore may reduce the complications
From August 1st 2020 the AC patients undergoing LC in PUMCH were prospecteively registered and a database was established to collect related data
Till 1st Feburary 2024 about 750 cases of ELC were performed The surgeons chose to perform either conventional ELC or ELC-ICGC based on their discretion The patients were followed up within one month after discharge in out patient clinic or telephone interview We plan to analyze the data from the prospectively established- database
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 of these two procedures will be compared
From August 1st 2020 the AC patients undergoing LC in PUMCH were prospecteively registered and a database was established to collect related data
Till 1st Feburary 2024 about 750 cases of ELC were performed The surgeons chose to perform either conventional ELC or ELC-ICGC based on their discretion The patients were followed up within one month after discharge in out patient clinic or telephone interview We plan to analyze the data from the prospectively established- database
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 of these two procedures will be compared
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