Brief Title
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis
Official Title
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?
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.
Detailed Description
Double blind randomized clinical trial
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Incidence of infectious postoperative complications
Secondary Outcome
Number of days of hospital stay or readmissions.
Condition
Acute Cholecystitis
Intervention
Amoxicillin clavulanic
Study Arms / Comparison Groups
Group A (Amoxicillin Clavulanic)
Description: Intake of active drug (Amoxicillin Clavulanic). 3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
February 2014
Completion Date
May 2018
Primary Completion Date
March 2017
Eligibility Criteria
Inclusion Criteria:
- 18 to 85 years old
- Patients with diagnose of mild or moderate acute cholecystitis.
- Underwent laparoscopic cholecystectomy on Italian Hospital of Buenos Aires
Exclusion Criteria:
- They refuse to participate from the trial or the process of informed consent.
- Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo).
- Patients with severe cholecystitis
- Patients with moderate cholecystitis who presents liver abscess, gallbladder abscess,
cholangitis or bile peritonitis.
- Intraoperative findings like liver cancer, liver metastases, common bile duct stones
or gallbladder carcinoma.
- Patients with conversion to laparotomy
- Previous treatment with antibiotics for more than five days.
- Patients with active oncological diseases, AIDS, diabetes, transplanted.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Martin de Santibañes, MD, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT02057679
Organization ID
2111
Responsible Party
Principal Investigator
Study Sponsor
Hospital Italiano de Buenos Aires
Study Sponsor
Martin de Santibañes, MD, Principal Investigator, Hospital Italiano de Buenos Aires
Verification Date
February 2019