Ignite Creation Date:
2024-05-06 @ 2:29 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02057679
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2014-02-05
Brief Title:
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Hospital Italiano de Buenos Aires
Study Overview
Official Title:
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis Is it Necessary
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Acute cholecystitis AC is a very common complication of cholelithiasis encountered in 20 of symptomatic patients
Nowadays laparoscopic cholecystectomy LC is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion However in the beginning AC presents itself as an steril process the obstruction of the cystic duct initiates a cascade of inflammation ischaemia and necrosis as well as bacterial proliferation within the gallbladder lumen Bactibilia was a significant factor associated with total as well as infectious operative complications Regarding this for some authors monotherapy with amoxicillin clavulanic AMC would be the best treatment after LC in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis cholangitis gallbladder perforation or abscess In the other hand others do not prescribe antimicrobial treatment after surgery in these selected patients
There is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic
Therefore investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer The patients will be randomized to receive AMC or placebo after surgery With this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with AMC and placebo
The primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed
Nowadays laparoscopic cholecystectomy LC is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion However in the beginning AC presents itself as an steril process the obstruction of the cystic duct initiates a cascade of inflammation ischaemia and necrosis as well as bacterial proliferation within the gallbladder lumen Bactibilia was a significant factor associated with total as well as infectious operative complications Regarding this for some authors monotherapy with amoxicillin clavulanic AMC would be the best treatment after LC in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis cholangitis gallbladder perforation or abscess In the other hand others do not prescribe antimicrobial treatment after surgery in these selected patients
There is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic
Therefore investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer The patients will be randomized to receive AMC or placebo after surgery With this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with AMC and placebo
The primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed
Detailed Description:
Double blind randomized clinical trial
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