Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.
Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations.
Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics perioperative | Other | dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department |
|
| placebo - No Antibiotics perioperative | Placebo Comparator | The intervention is No Antibiotics perioperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefamezin 1g IV | Drug | perioperative antibiotics (Cefamizin 1g IV; ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC). | Criteria for a superficial incisional SSI are an infection occurring at the incision site within 30 days after surgery that involved only the skin and subcutaneous tissue and at least one of the following: purulent drainage from the incision; an organism isolated from a culture of fluid from the superficial incision; incisional pain, tenderness, localized swelling, redness, or heat, and the wound was opened; | 30 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Hershko, Professor | Contact | 972+46494391 | dan_he@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Dan Hershko, Professor | haemek medical center | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D002439 | Cefotaxime |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| metronidazole 500 mg IV | Drug | perioperative antibiotics (metronidazole 500 mg IV ) |
|
|
| Placebo | Drug | No perioperative antibiotics |
|
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002505 | Cephacetrile |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |