Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

NCT02057679 | Completed Phase 4 DMC

• 1 other identifier: 2111
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

Acute cholecystitis.; Amoxicillin clavulanic

Outcome Measures

Primary Outcomes (1)

• Incidence of infectious postoperative complications

  Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to acute mild and moderate cholecystitis, with antibiotics or placebo

  30 days

Secondary Outcomes (2)

• Number of days of hospital stay or readmissions.

  30 days

• Number of surgical reinterventions or reoperations.

  30 days

Study Arms (2)

Group A (Amoxicillin Clavulanic)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Optamox

Group A (Amoxicillin Clavulanic)

Placebo DRUG

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

Also known as: Lactose

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years old
• Patients with diagnose of mild or moderate acute cholecystitis.
• Underwent laparoscopic cholecystectomy on Italian Hospital of Buenos Aires

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, 1199, Argentina

Location

Related Publications (10)

• Strasberg SM. Clinical practice. Acute calculous cholecystitis. N Engl J Med. 2008 Jun 26;358(26):2804-11. doi: 10.1056/NEJMcp0800929. No abstract available.

  PMID: 18579815 BACKGROUND

• Yoshida M, Takada T, Kawarada Y, Tanaka A, Nimura Y, Gomi H, Hirota M, Miura F, Wada K, Mayumi T, Solomkin JS, Strasberg S, Pitt HA, Belghiti J, de Santibanes E, Fan ST, Chen MF, Belli G, Hilvano SC, Kim SW, Ker CG. Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):83-90. doi: 10.1007/s00534-006-1160-y. Epub 2007 Jan 30.

  PMID: 17252301 BACKGROUND

• Yildiz B, Abbasoglu O, Tirnaksiz B, Hamaloglu E, Ozdemir A, Sayek I. Determinants of postoperative infection after laparoscopic cholecystectomy. Hepatogastroenterology. 2009 May-Jun;56(91-92):589-92.

  PMID: 19621660 BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF; Tokyo Guidelines Revision Committee. New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines. J Hepatobiliary Pancreat Sci. 2012 Sep;19(5):578-85. doi: 10.1007/s00534-012-0548-0.

  PMID: 22872303 BACKGROUND

• Kanafani ZA, Khalife N, Kanj SS, Araj GF, Khalifeh M, Sharara AI. Antibiotic use in acute cholecystitis: practice patterns in the absence of evidence-based guidelines. J Infect. 2005 Aug;51(2):128-34. doi: 10.1016/j.jinf.2004.11.007. Epub 2005 Jan 20.

  PMID: 16038763 BACKGROUND

• Grande M, Torquati A, Farinon AM. Wound infection after cholecystectomy. Correlation between bacteria in bile and wound infection after operation on the gallbladder for acute and chronic gallstone disease. Eur J Surg. 1992 Feb;158(2):109-12.

  PMID: 1350211 BACKGROUND

• Galili O, Eldar S Jr, Matter I, Madi H, Brodsky A, Galis I, Eldar S Sr. The effect of bactibilia on the course and outcome of laparoscopic cholecystectomy. Eur J Clin Microbiol Infect Dis. 2008 Sep;27(9):797-803. doi: 10.1007/s10096-008-0504-8. Epub 2008 Mar 28.

  PMID: 18369670 BACKGROUND

• Pellegrini P, Campana JP, Dietrich A, Goransky J, Glinka J, Giunta D, Barcan L, Alvarez F, Mazza O, Sanchez Claria R, Palavecino M, Arbues G, Ardiles V, de Santibanes E, Pekolj J, de Santibanes M. Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART). BMJ Open. 2015 Nov 18;5(11):e009502. doi: 10.1136/bmjopen-2015-009502.

  PMID: 26582405 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Amoxicillin-Potassium Clavulanate Combination; Lactose

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Martin de Santibañes, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Diego Giunta, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

AR (1)