Non Operative Treatment for Acute Appendicitis

Summary

Case control studies that randomly assign patients to either surgical or non-surgical treatment yield a relapse rate of approximately 14% at one year. It would be useful to know the relapse rate of patients who have, instead, been selected for a given treatment based on a thorough clinical evaluation, including physical examination and laboratory results (all characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed helpful. If this clinical evaluation is useful,the investigators would expect patient selection to be better than chance, and relapse rate lower than 14%. Once the investigators have established the utility of this evaluation, the investigators can begin to identify those components that have predictive value (such as blood chemistry analysis, or CT findings). This is the first step toward developing an accurate diagnostic-therapeutic algorithm which will avoid the risks and costs of needless surgery.

This will be a single-cohort prospective interventional study. It will not interfere with the usual procedures, consisting of clinical examination in the Emergency Department (ED) and execution of the following exams at the physician's discretion: complete blood count with differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing immediate surgery, are requested by informed consent to undergo observation and non operative treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid). The patients by protocol should not have received any previous antibiotic treatment during the same clinical episode. Patients not undergoing surgery will be physically examined 5 days later. During this follow-up visit, the patient will be given information about the study, will be invited to participate, and will be asked to sign an informed consent form. If the patient is under the age of 18 years, consent will be obtained from a parent or other legal guardian.

Telephone (or email) follow-ups will be conducted at 15 days, 6 months, and 12 months (see attached schedule) to monitor the state of the illness.

Conditions

• Lower Abdominal Pain
• Right Iliac Fossa Pain
• Acute Appendicitis

Interventions

DRUG

Amoxicillin and Clavulanic Acid

7 days antibiotic therapy with Amoxicillin and Clavulanic Acid, 1 gr 3 times daily PO

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna

  lead OTHER

Principal Investigators

• Gregorio Tugnoli, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Gregorio Tugnoli, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Nicola Antonacci, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Salomone Di Saverio, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Franco Baldoni, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Andrea Biscardi, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Silvia Villani, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Eleonora Giorgini, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Gianluca Senatore, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

• Nicola Clemente, MD · Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-01-31

Completion

2011-02-28

Countries

• Italy

Study Locations