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Non Operative Treatment for Acute Appendicitis (NOTA)

This study has been completed.
Sponsor:
Information provided by:
Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier:
NCT01096927
First received: March 29, 2010
Last updated: July 26, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Lower Abdominal Pain
Right Iliac Fossa Pain
Acute Appendicitis
Drug: Amoxicillin and Clavulanic Acid
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non Operative Treatment for Acute Appendicitis: Study on Efficacy and Safety of Antibiotic Treatment (Amoxicillin and Clavulanic Acid) in Patients With Right Sided Lower Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Maggiore Bellaria Hospital, Bologna:

Primary Outcome Measures:
  • Short Term Efficacy of Antibiotic Treatment [ Time Frame: within 7 days (Antibiotic treatment course) ] [ Designated as safety issue: Yes ]
    Failure of the conservative treatment with antibiotic within the period of the Amoxicillin + Clavulanic Acid therapy (7 days), defined as readmission for abscence of clinical improvement and/or worsening abdominal pain and/or localized/diffuse peritonitis

  • Long Term Efficacy of Antibiotic Treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Efficacy of antibiotic therapy for acute appendicitis defined as incidence of recurrences of clinical episodes of appendicitis up to 1 year follow up (at 15 days, 6 months, 1 year)

  • Long Term Efficacy of Antibiotic Treatment (NO need for surgery) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Efficacy of antibiotic therapy for acute appendicitis defined as definite improvement without need for surgery within 1 year follow up (at 15 days, 6 months, 1 year)

  • Safety of Antibiotic treatment [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Major side effects/complications drug/treatment-related (i.e. Allergy or other complications treatment related such as abscess formation)


Secondary Outcome Measures:
  • Minor Complications [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    Minor side effects/complications drug/treatment-related (i.e. bloating, diarrhea, gas, headache, heartburn, nausea, and vomiting) (at 7 days, 15 days)

  • Abdominal Pain after discharge [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Assessment of abdminal pain / discomfort evaluated by mean of Numerical rating scale (NRS) (at 7 days, 15 days)

  • Length of Hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Length of clinical observation as inpatient

  • Outpatient clinic checkup [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Number of follow up appointments scheduled in outpatient clinic

  • Sick Leave [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of days of sick leave needed by the patient (assessed at 7 days, 15 days, 6 months, 1 year)

  • Cost analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Analysis of the costs, including Antibiotic course, Length of Hospital Stay, Outpatient Clinic follow up appointments, sick leave days


Enrollment: 160
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non operative Treatment group
Patients with Lower Abdominal and suspected Acute Appendicitis, treated non-operatively with 7 days antibiotic therapy (Amoxicillin and Clavulanic Acid)
Drug: Amoxicillin and Clavulanic Acid
7 days antibiotic therapy with Amoxicillin and Clavulanic Acid, 1 gr 3 times daily PO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >14 years
  2. Lower / RIF Abdominal Pain
  3. Clinical Suspicion of Acute Appendicitis:

    i.e.

    • Alvarado Score 5-6 (equivocal for acute appendicitis)
    • Alvarado Score 7-8 (probably appendicitis)
    • Alvarado Score 9-10 (highly likely appendicitis)
  4. Informed consent (patient or legal representative)

Exclusion Criteria:

  1. Diffuse peritonitis
  2. Antibiotic (Penicillin) documented allergy
  3. Ongoing previously started antibiotic therapy
  4. Previous appendectomy
  5. Positive pregnancy test
  6. IBD history or suspicion of IBD recrudescence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096927

Locations
Italy
Maggiore Bellaria Hospital
Bologna, Italy, 40100
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
Investigators
Study Chair: Gregorio Tugnoli, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Study Director: Gregorio Tugnoli, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Study Director: Nicola Antonacci, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Study Director: Salomone Di Saverio, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Study Director: Franco Baldoni, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Principal Investigator: Andrea Biscardi, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Principal Investigator: Silvia Villani, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Principal Investigator: Eleonora Giorgini, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Principal Investigator: Gianluca Senatore, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
Principal Investigator: Nicola Clemente, MD Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregorio Tugnoli, Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital Trauma Center
ClinicalTrials.gov Identifier: NCT01096927     History of Changes
Other Study ID Numbers: CE 09079
Study First Received: March 29, 2010
Last Updated: July 26, 2011
Health Authority: Italy: Bologna Local Health District -Regional Health Agency

Keywords provided by Maggiore Bellaria Hospital, Bologna:
Lower Abdominal Pain
Right Iliac Fossa Pain
Acute Appendicitis
Antibiotic Therapy
Conservative Management
Appendectomy
Recurrence
Length of hospital stay
Sick leave time
Short and Long Term Abdominal pain evaluation

Additional relevant MeSH terms:
Abdominal Pain
Acute Disease
Appendicitis
Cecal Diseases
Digestive System Diseases
Disease Attributes
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Intraabdominal Infections
Pain
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014