Loading search results
NOTA
Sponsor study identifier
interventional
160
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
February 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 29, 2010
Actual (reported)March 31, 2010
Actual (reported)January 2011
Actual (reported)February 2011
Actual (reported)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)
Patients with Lower Abdominal and suspected Acute Appendicitis, treated non-operatively with 7 days antibiotic therapy (Amoxicillin and Clavulanic Acid)
7 days antibiotic therapy with Amoxicillin and Clavulanic Acid, 1 gr 3 times daily PO
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Amoxicillin and Clavulanic Acid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMaggiore Bellaria Hospital
Bologna, 40100, Italy
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.
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.
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.
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
160 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2010
First Posted
March 31, 2010
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
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
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
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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
Primary Completion
January 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
July 27, 2011
Record last verified: 2011-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: