Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05736003
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2023-02-09
Brief Title:
Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis
Sponsor:
South Valley University
Organization:
South Valley University
Study Overview
Official Title:
Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis Time to Change the Concept - A Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
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:
Gallbladder stone affects 10-15 of the adult population and about 15-25 of these patients presented with acute cholecystitis AC Laparoscopic cholecystectomy LC is considered the treatment of choice for patients with AC and recent studies suggest that early laparoscopic cholecystectomy ELC is preferable However the optimal time for ELC in AC is still controversial
Early laparoscopic cholecystectomy ELC was advised for patients presented within 72 hours while conservative treatment and planned delayed laparoscopic cholecystectomy DLC after six weeks was recommended for patients presented after 72 hours Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC
Early laparoscopic cholecystectomy ELC was advised for patients presented within 72 hours while conservative treatment and planned delayed laparoscopic cholecystectomy DLC after six weeks was recommended for patients presented after 72 hours Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC
Detailed Description:
Gallbladder stone affects 10-15 of the adult population and about 15-25 of these patients presented with acute cholecystitis AC Laparoscopic cholecystectomy LC is considered the treatment of choice for patients with AC and recent studies suggest that early laparoscopic cholecystectomy ELC is preferable However the optimal time for ELC in AC is still controversial
Early laparoscopic cholecystectomy ELC was advised for patients presented within 72 hours while conservative treatment and planned delayed laparoscopic cholecystectomy DLC after six weeks was recommended for patients presented after 72 hours ELC might be associated with a significant reduction in morbidity and mortality rates comparable conversion rates shorter hospital stays lower costs and higher patient satisfaction
Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC Additionally 15 of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25 of patients require re-hospitalization for recurrent attacks of AC and biliary colic biliary pancreatitis cholangitis and calcular obstructive jaundice during the interval waiting for the DLC Furthermore DLC has a higher cost and is time-consuming
Prolonged LC PLC for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms and this may be associated with increased perioperative complications and conversion rate On the contrary others believed that hyperemia and edema may help the dissection All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms
More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms
Early laparoscopic cholecystectomy ELC was advised for patients presented within 72 hours while conservative treatment and planned delayed laparoscopic cholecystectomy DLC after six weeks was recommended for patients presented after 72 hours ELC might be associated with a significant reduction in morbidity and mortality rates comparable conversion rates shorter hospital stays lower costs and higher patient satisfaction
Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC Additionally 15 of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25 of patients require re-hospitalization for recurrent attacks of AC and biliary colic biliary pancreatitis cholangitis and calcular obstructive jaundice during the interval waiting for the DLC Furthermore DLC has a higher cost and is time-consuming
Prolonged LC PLC for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms and this may be associated with increased perioperative complications and conversion rate On the contrary others believed that hyperemia and edema may help the dissection All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms
More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms
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