Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00135603
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2005-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}, {'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2005-08-24', 'studyFirstSubmitQcDate': '2005-08-24', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of intra abdominal infections in both therapeutic strategies', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'duration of pain', 'timeFrame': '30 days'}, {'measure': 'duration of hospitalisation', 'timeFrame': '30 days'}, {'measure': 'duration of absence from work', 'timeFrame': '30 days'}, {'measure': 'rate of wound infection', 'timeFrame': '30 days'}, {'measure': 'recurrence of appendicitis', 'timeFrame': '12 months'}, {'measure': 'rate of abdominal hernia', 'timeFrame': '12 months'}, {'measure': 'rate of adhesive intestinal occlusion', 'timeFrame': '12 months'}, {'measure': 'cost', 'timeFrame': '30 days and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['appendicitis.', 'adult.', 'treatment.', 'antibiotic therapy.', 'CT scanning.', 'randomized trial', 'safety'], 'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '21550483', 'type': 'DERIVED', 'citation': 'Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.', 'detailedDescription': 'Appendectomy is the most frequent intra-abdominal operation performed, accounting for the majority of admissions in a general surgery unit. Appendectomy has always been considered the cornerstone in the treatment of acute appendicitis.Nevertheless, the idea of a conservative treatment using antibiotics is not that recent. Current practices have proven the efficiency of antibiotic therapy in treating certain infectious abdominal conditions including: appendicular mass with or without periappendicular abscess and acute diverticulitis. This success has prompted the researchers to consider the exclusive use of antibiotic therapy in the treatment of non complicated appendicitis.\n\nIn patients with clinical suspicion of acute appendicitis (localized abdominal tenderness, inflammatory reaction...etc) a CT scan will be performed to confirm the diagnosis of non complicated appendicitis. This diagnosis is confirmed on the CT in the absence of any sign of either localized peritonitis, and/or perforation (extraluminal gas, appendicular abscess, or phlegmon).\n\nAfter a thorough explanation of this study, the patient will be obliged to sign a written consent. Patients will be randomly assigned to either one of the two therapeutic modalities : an appendectomy,or an antibiotic treatment consisting of amoxicillin and clavulanate potassium.\n\nThis therapy will be continued until the normalisation of leucocytic count and C reactive protein are achieved. In order to demonstrate equivalent conclusive results comparing the two treatment modalities, the statistical consultant estimated the inclusion of at least 200 patients in the study. However, after considering the possible loss of a number of patients following their inclusion for a variety of reasons, it was decided that a total of 250 patients will be enrolled.\n\nRate of intra abdominal infections in both therapeutic strategies is the first endpoint to be compared. Duration of pain, diet, hospitalisation, absence from work will also be compared. In the group of patients treated by antibiotics, the rate of persistant and recurrent appendicitis after treatment will be evaluated. Recurrent appendicitis is not considered a complication as long as the recurrence of the appendicitis is uncomplicated. During the followup period of one year, long-term complications will be observed including: abdominal hernia, adhesive intestinal occlusion, and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Before CT scanning\n\nInclusion Criteria:\n\n* Clinical suspicion of appendicitis\n* Age more than 18 years\n\nExclusion Criteria:\n\n* Clinical signs of generalized peritonitis\n* Previous take of antibiotics within the 5 days preceding the presentation\n* Allergy or intolerance to lactamases and/or clavulanate potassium\n* Corticosteroid or anticoagulant therapy\n* Patient with a known inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Pregnant women\n* Patient with iode allergy\n* Renal insufficiency (creatinine \\> 200 )\n\nCT scanning:\n\nInclusion Criteria:\n\n* Appendix diameter \\> 6 mm\n\nExclusion Criteria:\n\n* Appendix non visualised\n* Signs of localized peritonitis:\n\n * extradigestive gas\n * fluid collection around the appendix\n * generalized intraperitoneal fluid"}, 'identificationModule': {'nctId': 'NCT00135603', 'briefTitle': 'Antibiotic Therapy Versus Appendectomy for Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis', 'orgStudyIdInfo': {'id': 'P020915'}, 'secondaryIdInfos': [{'id': 'AOR 02063'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'appendectomy, actual usual treatment', 'interventionNames': ['Procedure: appendectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'antibiotic therapy', 'interventionNames': ['Drug: amoxicillin/clavulanate potassium']}], 'interventions': [{'name': 'amoxicillin/clavulanate potassium', 'type': 'DRUG', 'description': '1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks', 'armGroupLabels': ['B']}, {'name': 'appendectomy', 'type': 'PROCEDURE', 'description': 'ablation of the appendix by laparotomy or laparoscopy', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92141 cedex', 'city': 'Clamart', 'country': 'France', 'facility': 'Antoine Béclère Hospital - Department of Surgery', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hotel Dieu Hospital, Department of Digestive Surgery', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital, Department of Digestive Surgery', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Lariboisière Hospital, Department of Digestive Surgery', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Corinne Vons, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Corinne VONS, MD, PhD', 'oldOrganization': 'Assistance Publique Hôpitaux de Paris'}}}}