We wish to investigate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and rhGM-CSF followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. MedDRA version: 20.0 Level: LLT Classification code 10000680 Term: Acute appendicitis without mention of peritonitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Repomol
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: rhGM-CSF
CAS Number: 8000048-22-8
Other descriptive name: GRANULOCYTE MACROPHAGE COLONY STIM FACTOR
Co
Sponsors
Department of Surgery, Herlev Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =18 years Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy Perforated appendicitis (diagnosed during surgery by the surgeon) Negative p-HCG (women) Written informed consent after written and verbal information (preoperatively at Herlev Hospital and postoperatively at Bispebjerg Hospital) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Cannot understand, read or speak Danish Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation Other intra-abdominal pathology requiring surgical intervention at the same operation Known renal or hepatic disease or biochemical evidence at the time of admission Known hematologic disease in current medical treatment American Society of Anesthesiologists (ASA) physical status =4 (a patient with severe systemic disease that is a constant threat to life) Body weight >110 kg Surgery converted to open appendectomy Anticipated compliance problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation (not before operation) and until 30-day follow-up.;Secondary Objective: Secondary outcomes include Gastrointestinal Quality of Life Index (GIQLI), postoperative complications according to the Clavien-Dindo grading, surgical site infections requiring surgical drainage, intraabdominal abscesses requiring drainage, readmissions, reoperations, time to return to normal activities, period of sick leave “absence from work”, and costs. All are measured up to 30 days postoperatively. Further, if an infectious complication occurs, investigations of the specimens’ microbiological flora including susceptibility testing for the antibiotics used for treatment will be undertaken. Side effects will be monitored through a questionnaire.;Primary end point(s): Total length of in hospital stay (measured in hours) is defined as from end of the operation until discharge from the hospital plus length of stay during a possible readmission within 30 days from surgery.;Timepoint(s) of evaluation of this end point: This will be calculated at the patient’s record review 30 days postoperatively (±3 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): GIQLI: a disease-specific questionnaire validated in Danish is collected at 10 days postoperatively (±2 day) and at 30 days postoperatively (±3 days). Postoperative complications: according to the Clavien-Dindo grading: information regarding complications is collected after surgery during hospital stay, 10 days postoperatively (±2 day) when the patients have their sutures removed by the trial personnel and 30 days (±3 days) postoperatively through review of the patients’ medical records and by the planned telephone interview. Deep surgical site infection postoperatively: Information regarding surgical site infections is collected 10 days postoperatively (±2 day) when the patients have their sutures removed by the trial personnel and 30 days (±3 days) postoperatively through review of the patient’s medical records and at the planned telephone call to the patients. It is defined as deep incisional surgical site infection according to Centre for Disease Control and Prevention (CDC). Intraabdominal abscess: Information regarding intraabdominal abscesses is collected 10 days postoperatively (±2 day) when the patients have their sutures removed by the trial personnel and 30 days (±3 days) postoperatively through review of the patient’s medical records and at the planned telephone interview. It is defined as an organ/space surgical site infection according to CDC. If a collection is found but not drained, it is not regarded as an abscess by definition in the current trial. Readmissions: Information will be collected 30 days (±3 days) postoperatively by review of the patient’s medical records and at the planned telephone interview. Only readmissions related to the surgery will be registered; e.g. admission and treatment of a non-related condition will not be registered. Reoperations: Information will be collected 30 days (±3 days) postoperatively by review of the patient’s medical records and at the planned telephone interview. Time to return to norm | — |
Countries
Denmark
Contacts
Public ContactCPO office
Department of Surgery
Outcome results
None listed