Non Operative Treatment for Acute Appendicitis

NCT01096927 | Completed Phase 4

• 1 other identifier: CE 09079
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Short Term Efficacy of Antibiotic Treatment

  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

  within 7 days (Antibiotic treatment course)

• Long Term Efficacy of Antibiotic Treatment

  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)

  1 year

• Long Term Efficacy of Antibiotic Treatment (NO need for surgery)

  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)

  1 year

• Safety of Antibiotic treatment

  Major side effects/complications drug/treatment-related (i.e. Allergy or other complications treatment related such as abscess formation)

  7 days

Secondary Outcomes (6)

• Minor Complications

  15 days

• Abdominal Pain after discharge

  15 days

• Length of Hospital stay

  7 days

• Outpatient clinic checkup

  15 days

• Sick Leave

  1 year

Study Arms (1)

Non operative Treatment group

EXPERIMENTAL

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

Interventions

Amoxicillin and Clavulanic Acid DRUG

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

Non operative Treatment group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>14 years
• Lower / RIF Abdominal Pain
• 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)
• Informed consent (patient or legal representative)

You may not qualify if:

• Diffuse peritonitis
• Antibiotic (Penicillin) documented allergy
• Ongoing previously started antibiotic therapy
• Previous appendectomy
• Positive pregnancy test
• IBD history or suspicion of IBD recrudescence

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna: lead

Study Sites (1)

Maggiore Bellaria Hospital

Bologna, 40100, Italy

Location

Related Publications (8)

• Malik AA, Bari SU. Conservative management of acute appendicitis. J Gastrointest Surg. 2009 May;13(5):966-70. doi: 10.1007/s11605-009-0835-5. Epub 2009 Mar 10.

  PMID: 19277796 BACKGROUND

• Deutsch AA, Shani N, Reiss R. Are some some appendectomies unnecessary? An analysis of 319 white appendices. J R Coll Surg Edinb. 1983 Jan;28(1):35-40. No abstract available.

  PMID: 6834311 BACKGROUND

• Pieper R, Kager L, Nasman P. Acute appendicitis: a clinical study of 1018 cases of emergency appendectomy. Acta Chir Scand. 1982;148(1):51-62. No abstract available.

  PMID: 7136412 BACKGROUND

• Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.

  PMID: 16736333 BACKGROUND

• Eriksson S, Granstrom L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. doi: 10.1002/bjs.1800820207.

  PMID: 7749676 BACKGROUND

• Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009 May;96(5):473-81. doi: 10.1002/bjs.6482.

  PMID: 19358184 BACKGROUND

• Di Saverio S, Sibilio A, Giorgini E, Biscardi A, Villani S, Coccolini F, Smerieri N, Pisano M, Ansaloni L, Sartelli M, Catena F, Tugnoli G. The NOTA Study (Non Operative Treatment for Acute Appendicitis): prospective study on the efficacy and safety of antibiotics (amoxicillin and clavulanic acid) for treating patients with right lower quadrant abdominal pain and long-term follow-up of conservatively treated suspected appendicitis. Ann Surg. 2014 Jul;260(1):109-17. doi: 10.1097/SLA.0000000000000560.

  PMID: 24646528 DERIVED

• Tugnoli G, Giorgini E, Biscardi A, Villani S, Clemente N, Senatore G, Filicori F, Antonacci N, Baldoni F, De Werra C, Di Saverio S. The NOTA study: non-operative treatment for acute appendicitis: prospective study on the efficacy and safety of antibiotic treatment (amoxicillin and clavulanic acid) in patients with right sided lower abdominal pain. BMJ Open. 2011 Feb 23;1(1):e000006. doi: 10.1136/bmjopen-2010-000006.

  PMID: 22021722 DERIVED

MeSH Terms

Conditions

Appendicitis; Recurrence

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Gregorio Tugnoli, MD

  Emergency and Trauma Surgery Unit, Department of Emergency, Maggiore Hospital

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 31, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 27, 2011

Record last verified: 2011-01

Locations

IT (1)