Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

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Brief Title

Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

Official Title

Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

Brief Summary

      The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy
      for acute cholecystitis is insufficiently known. The aim of the present double-blind
      randomized controlled is to compare piperacilin with placebo in patients undergoing
      cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100
      patients are intended to be included. Primary endpoint is biliary contamination. Secondary
      endpoints are postoperative hospital stay, health-related quality of life, pain perception,
      postoperative markers of inflammatory response, surgical site infections, infectious
      complications other than surgical site infections, health economy and relationship between
      symptom anamnesis and bile contamination.
    

Detailed Description

      Background

      Inflammation in the gallbladder due to obstruction of gallstones (acute cholecystitis) is a
      common condition and one of the most common indications for laparoscopic cholecystectomy. In
      most cases, the procedure may be performed without great risk of severe complications. In
      some cases, however, the congested bile in the gallbladder may become infected.

      In clinical routine, acute cholecystitis is often managed as an infectious condition, despite
      the fact that previous studies have shown that the bile in most cases of acute cholecystitis
      is sterile. On the other hand, antibiotic prophylaxis may reduce the risk of surgical site
      infections in those cases when there is a manifest bacterial contamination and, perhaps, also
      reduce the risk of contamination. There is firm evidence supporting acute surgery,
      prefereably laparoscopic cholecystectomy, but the benefit from antibiotic treatment has not
      been full evaluated.

      Previous studies have shown that the benefit from antibiotic prophylaxis is very limited in
      case of laparoscopic cholecystectomy for uncomplicated gallstone disease. There are, however,
      very few studies that have assessed antibiotic prophylaxis in surgery for acute
      cholecystitis.

      The aim of the present study is to assess the benefit of antibiotic prophylaxis in patients
      undergoing laparoscopic cholecystectomy for acute cholecystitis.

      Methods The study is based on patients admitted for acute cholecystitis at the department of
      acute surgery, Karolinska University Hospital Huddinge. In case the patients fulfill the
      inclusion critera and are suitable for laparoscopic surgery, written and oral information
      about the study is given.

      In case they agree to participate in the study, treatment allocation is determined by a
      sealed envelope system. The patients are randomised to receive either Piperacillin 4g x 3 iv
      preoperatively as prophylaxis or placebo (saline infusion). The study is double-blind.
      Piperacillin/placebo is administrated by a research nurse after allocation. The infusion is
      covered by a bag in order to maintain blinding. Neither the surgeon performing the procedure,
      nor the patient or staff caring for the patient are informed about the allocation. The
      procedure should be performed within 24 days after inclusion. Administration of
      Piperacillin/placebo is started immediately after inclusion and continued until the procedure
      is completed.

      If a categorical indication for antibiotic treatment occurs during surgery, the allocated
      infusion is removed and the patient is given antibiotic as decided by the surgeon. In such
      cases, the patient stays in the study and is analysed according to an intention to treat.

      During the laparoscopic cholecystectomy, at least 10 cc of bile is aspirated under sterile
      conditions from the fundus of the gallbladder with a long needle before the start of the
      peritoneum dissection. The bile is sent for aerobic and anaerobic culture. Bacteria are
      identified using standard laboratory procedures.

      Sample size estimation If the incidence of positive cultures is 50% and in the placebo group
      and this is reduced to 25% if antibiotic prophylaxis is given, 36 patients in each arm would
      be required in order to reach 80% chance of detecting this difference at a p<0.05 level of
      significance (one sided test). A total sample of 100 patients should thus be sufficient to
      test the primary outcome measure.

      Follow-up Samples for CRP, interleukins, bilirubin, AST, ALT and ALP are taken daily from the
      peroperative day until postoperative day 2.

      Quality of life is assessed by SF-36 preoperatively. Level of pain is estimated based on the
      MacGill Pain Questionnaire from the day of the procedure until postoperative day 2.

      One month postoperatively, the patient is invited to follow-up. At follow-up, SF-36 is filled
      in.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of positive bacterial cultures

Secondary Outcome

 Postoperative hospital stay

Condition

Cholecystitis, Acute

Intervention

Piperacillin-tazobactam combination product

Study Arms / Comparison Groups

 Intervention
Description:  Piperacillin-tazobactam combination product

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

March 2009

Completion Date

January 2018

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical and radiologic signs of acute cholecystitis

          -  First acute symptoms occurring within five days before surgery

        Exclusion Criteria:

          -  Anamnesis exceeding five days

          -  Any contraindication for laparoscopic surgery

          -  Allergy against beta-lactame antibiotics
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Folke Hammarqvist, Ass Prof, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02619149

Organization ID

AVAC


Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet


Study Sponsor

Folke Hammarqvist, Ass Prof, Principal Investigator, Karolinska Institutet, CLINTEC, Stockholm


Verification Date

March 2018