Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

• ClinicalTrials.gov Identifier: NCT02057679
• Recruitment Status: Completed
• First Posted: February 7, 2014
• Last Update Posted: February 27, 2019
• Sponsor: Hospital Italiano de Buenos Aires
• Information provided by (Responsible Party): MARTIN DE SANTIBAÑES, Hospital Italiano de Buenos Aires

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Argentina

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, Argentina, 1199

Sponsors and Collaborators

Hospital Italiano de Buenos Aires

Investigators

• Principal Investigator: Martin de Santibañes, MD; Hospital Italiano de Buenos Aires
• Study Director: Diego Giunta, MD; Hospital Italiano de Buenos Aires

More Information

Publications:

Strasberg SM. Clinical practice. Acute calculous cholecystitis. N Engl J Med. 2008 Jun 26;358(26):2804-11. doi: 10.1056/NEJMcp0800929. Review. Erratum in: N Engl J Med. 2008 Jul 17;359(3):325.

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. Epub 2007 Jan 30.

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.

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.

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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.

Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Büchler 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.

Kanafani ZA, Khalifé 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. Epub 2005 Jan 20. Review.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pellegrini P, Campana JP, Dietrich A, Goransky J, Glinka J, Giunta D, Barcan L, Alvarez F, Mazza O, Sánchez Claria R, Palavecino M, Arbues G, Ardiles V, de Santibañes E, Pekolj J, de Santibañes 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.

• Responsible Party: MARTIN DE SANTIBAÑES, MD, Hospital Italiano de Buenos Aires
• ClinicalTrials.gov Identifier: NCT02057679
• Other Study ID Numbers: 2111
• First Posted: February 7, 2014
• 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:

Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents