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
The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem | Experimental |
| |
| appendectomy | Active Comparator | Appendectomy is compared to Ertapenem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | Ertapenem i.v,m 1g, once a day, 3 days |
| |
| appendectomy |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year |
Rate of Diagnosis of new AA. We will register also the rate of intervention for bowel occlusion longer than 48 hours (no passage of flatus, vomit or combination) or intraperitoneal abscess. Further secondary outcome are Wound infection, negative appendectomy. Hospital stay and work absence. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Pisano, Principal investigator | Contact | 0039 0352673412 | mpisano@hpg23.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Ansaloni | Papa Giovanni XXIII Hospital Bergamo | Study Director |
| Michele Pisano | Papa Giovanni XXIII Hospital Bergamo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo | Recruiting | Bergamo | 24127 | Italy |
Not provided
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| D001062 | Appendectomy |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| 2 weeks- One year |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |