Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

NCT01015417 | Completed Phase 3 DMC

• 2 other identifiers: PHRCN09-PR-REGIMBEAUEudract N°2009-013470-41
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 21

Brief Summary

Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified. The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics. The secondary objectives are:

• Rates of infectious complications according to duration of preoperative antibiotic
• Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
• Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections)
• Comparison of germs found in the bile during the postoperative infectious complications
• Duration of hospitalization
• Readmission rate for surgical site infections
• Rate of reoperation for surgical site infection
• Overall mortality rate at 30 days
• Mortality rates specific to 30 days

Conditions

Acute Lithiasic Cholecystitis Grade I or II; Symptoms Lasting for Less Than 5 Days; Required Cholecystectomy; Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days

Keywords

Acute lithiasic cholecystitis; Cholecystectomy; Postoperative antibiotherapy; Surgical site infection; Remote surgical site infection

Outcome Measures

Primary Outcomes (1)

• All complications occurring during hospitalization or within 30 days postoperative. There are 2 main types of postoperative infectious complications: - Surgical site infections (SSI) - Systemic infections - Remote surgical site infections.

  30 days postoperative

Secondary Outcomes (9)

• Rates of infectious complications according to duration of preoperative antibiotic

  30 days postoperative

• Influence of surgical drainage after surgery for occurrence of postoperative infectious complications

  30 days postoperative

• Nature of infectious complications analysis (surgical site infections, infections distance)

  30 days postoperative

• Comparison of germs found in bile, the germs found in postoperative infectious complications

  since the infectious complication persist

• Duration of hospitalization

  until the release of hospitalization, otherwise at 30 days postoperative

Study Arms (2)

Amoxicillin clavulanic acid

ACTIVE COMPARATOR

Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.

Drug: Amoxicillin clavulanic acid

No medication

OTHER

no postoperative antibiotics

Other: No medication

Interventions

Amoxicillin clavulanic acid DRUG

Postoperative administration of 2g, 3 times daily, since 5 days, of amoxicillin clavulanic acid (Augmentin or generic) oral form or parenteral form according to clinical patient and by the choice of medical teams

Also known as: Augmentin, generic of amoxicillin clavulanic of any brand name, ATC class J01CR02

Amoxicillin clavulanic acid

No medication OTHER

no postoperative antibiotics

Also known as: No other name

No medication

Eligibility Criteria

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

You may qualify if:

• Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder)
• Requiring early cholecystectomy (progression of symptoms \<5 days
• In an adult patient (\>18 years)
• For each patient included the consent form must have been read, understood and signed.

You may not qualify if:

• Severe acute cholecystitis (with organ dysfunction)
• Acalculous cholecystitis
• Biliary peritonitis
• Abscess perivesicular
• Cholangitis
• Acute Pancreatitis
• Septic shock
• Stone of bile duct
• Physical or mental state does not allow participation in the study
• Contraindication to surgery
• Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy \<48 hours
• Suspected pre-or intraoperative cancer of the gallbladder
• Pregnancy or breastfeeding
• Treatment course with methotrexate, imidazole
• Known history of allergy to Augmentin ®

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (21)

Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire

Strasbourg, Alsace, 67098, France

Location

Centre Hospitalier Haut-Lévêque

Bordeaux, Aquitaine, 33604, France

Location

Centre Hopitalier Général

Grenoble, Auvergne-Rhône-Alpes, 38700, France

Location

Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire

Clermont-Ferrand, Auvergne, 63003, France

Location

Centre Hospitalier Côte e Nacre

Caen, Basse Normandie, 14033, France

Location

Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire

Besançon, Doubs, 25030, France

Location

Centre Hospitalier C.H.A.M.

Rang-du-Fliers, Hauts-de-France, 62180, France

Location

Service de Chirurgie Digetsive Centre Hopsitalier Universitaire

Montpellier, Hérault, 34000, France

Location

Centre Hospitalier

Longjumeau, Ile de Rance, 91161, France

Location

Centre Hospitalier Dupuytren

Limoges, Limousin, 87042, France

Location

Chirurgie viscérale et urologique Centre Hospitalier

Beauvais, Oise, 60021, France

Location

Centre hospitalier Universitaire

Angers, Pays de la Loire Region, 49933, France

Location

Service de Chirurgie Viscérale et Digestive

Amiens, Picardie, 80054, France

Location

Centre Hospitalier Timone

Marseille, Province-Alpes Côte d'Azur, 13000, France

Location

Chirurgie Viscérale et Digestive

Rouen, Seine Maritime, 76031, France

Location

Centre Hospitalier Jean-Verdier

Bondy, Île-de-France Region, 93143, France

Location

Centre Hospitalier Louis Mourier

Colombes, Île-de-France Region, 92700, France

Location

Service de Chirurgie Digestive et Viscérale

Paris, Île-de-France Region, 75020, France

Location

Centre hospitalier Lariboisière

Paris, Île-de-France Region, 75475, France

Location

Centre Hospitalier Cochin

Paris, Île-de-France Region, 75679, France

Location

Centre Hospitalier de Saint-Germain en Laye

Poissy, Île-de-France Region, 78303, France

Location

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• Fuks D, Duhaut P, Mauvais F, Pocard M, Haccart V, Paquet JC, Millat B, Msika S, Sielezneff I, Scotte M, Chatelain D, Regimbeau JM. A retrospective comparison of older and younger adults undergoing early laparoscopic cholecystectomy for mild to moderate calculous cholecystitis. J Am Geriatr Soc. 2015 May;63(5):1010-6. doi: 10.1111/jgs.13330. Epub 2015 May 6.

  PMID: 25946647 RESULT

• Regimbeau JM, Fuks D, Pautrat K, Mauvais F, Haccart V, Msika S, Mathonnet M, Scotte M, Paquet JC, Vons C, Sielezneff I, Millat B, Chiche L, Dupont H, Duhaut P, Cosse C, Diouf M, Pocard M; FRENCH Study Group. Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial. JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.

  PMID: 25005651 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Jean-marc REGIMBEAU, Pr

  Centre Hospitalier Universitaire, Amiens

  STUDY DIRECTOR

• David FUKS, Dr

  Centre Hospitalier Universiatire Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (21)