Skip to main content
OpenTrials
Completed

NCT Number: NCT02057679

Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, 1199, Argentina

About this study

Double blind randomized clinical trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin clavulanic

Drug

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 names: Optamox

Placebo

Drug

1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.

Other names: Lactose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy Due to Acute Cholecystitis. Is it Necessary?

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 7, 2014
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.