Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Proportion of positive bacterial cultures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
Piperacillin-tazobactam combination product
Intervention: Piperacillin-tazobactam combination product (Drug)
Control
Saline solution
Intervention: Saline solution (Drug)
Outcomes
Primary Outcomes
Proportion of positive bacterial cultures
Time Frame: 5 days
Proportion of patients with bacterial growth in the bile, assessed by culture from the bile assembled perioperatively.
Secondary Outcomes
- Surgical site infections(5-10 days)
- Postoperative hospital stay(5-10 days)
- Levels of C-reactive Protein postoperatively(3 days)
- Postoperative pain as measured by the McGill Pain Questionnaire(3 days)
- Health-related quality of life(One month)
- Infectious complications other than surgical site infections(5-10 days)
Investigators
Gabriel Sandblom
Associate Professor
Karolinska Institutet