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Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02057679
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
MARTIN DE SANTIBAÑES, Hospital Italiano de Buenos Aires

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.


Condition or disease Intervention/treatment Phase
Acute Cholecystitis Drug: Amoxicillin clavulanic Drug: Placebo Phase 4

Detailed Description:
Double blind randomized clinical trial

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?
Study Start Date : February 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Group A (Amoxicillin Clavulanic)
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.
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.
Other Name: Optamox

Placebo Comparator: Placebo
Intake of placebo (Lactose). 1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
Drug: Placebo
1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
Other Name: Lactose




Primary Outcome Measures :
  1. Incidence of infectious postoperative complications [ Time Frame: 30 days ]
    Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to acute mild and moderate cholecystitis, with antibiotics or placebo


Secondary Outcome Measures :
  1. Number of days of hospital stay or readmissions. [ Time Frame: 30 days ]
    To evaluate hospital stay.

  2. Number of surgical reinterventions or reoperations. [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057679


Locations
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Argentina
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires, Argentina, 1199
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Martin de Santibañes, MD Hospital Italiano de Buenos Aires
Study Director: Diego Giunta, MD Hospital Italiano de Buenos Aires

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MARTIN DE SANTIBAÑES, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02057679     History of Changes
Other Study ID Numbers: 2111
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Keywords provided by MARTIN DE SANTIBAÑES, Hospital Italiano de Buenos Aires:
Acute cholecystitis.
Amoxicillin clavulanic

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Amoxicillin
Anti-Infective Agents