Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-25 @ 4:27 AM
Study NCT ID:
NCT02848820
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2016-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children
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': 'D005839', 'term': 'Gentamicins'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients experiencing complications', 'timeFrame': 'One year follow up'}], 'secondaryOutcomes': [{'measure': 'Number of days absent from school, social or sport events', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Number of days absent from work', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain.', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Total length of hospital stay during the follow-up period for strategy related treatment or complications', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Total days of analgesics medication use.', 'timeFrame': 'one month'}, {'measure': 'Pain score measured by the Visual Analogue Scale (VAS)', 'timeFrame': 'Clinical phase (up to 7 days)'}, {'measure': 'Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Proportion of patients not having to undergone appendectomy', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Proportion of patients experiencing recurrent appendicitis', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Proportion of patients experiencing early failure of initial non-operative treatment.', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Proportion of patients that undergo interval appendectomy.', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy)', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Medical and non-medical costs (Health and Labor questionnaire)', 'timeFrame': '1,6,12 months'}, {'measure': "Quality adjusted life years (QALY's). Calculating using outcome 13 and 14", 'timeFrame': '1,6,12 months'}, {'measure': 'Patient satisfaction questionnaire (PSQ-18 & Net promotor score)', 'timeFrame': '7 days, 1,6,12 months'}, {'measure': 'Promoting and obstructing factors of implementability measured by questionnaires', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Appendicitis', 'Appendectomy', 'Antibiotics'], 'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '29146647', 'type': 'DERIVED', 'citation': 'Knaapen M, van der Lee JH, Bakx R, The SL, van Heurn EWE, Heij HA, Gorter RR; APAC collaborative study group. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). BMJ Open. 2017 Nov 15;7(11):e018145. doi: 10.1136/bmjopen-2017-018145.'}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVE\n\nThe aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs.\n\nMain research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?', 'detailedDescription': 'Initial non-operative treatment of acute simple appendicitis has recently been investigated in both the adult as the paediatric population. In the adult population, six Randomised Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the patients at the end of their follow-up period. Despite the fact that some patients need to undergo a delayed appendectomy, it has been demonstrated in systematic reviews that non-operative treatment strategy is associated with a significant reduction in complications, faster recovery and return to work, less pain duration and analgesic medication consumption. In children only pilot data is yet available. Short-term success rates of this strategy (including of the investigators own pilot cohort study) are between the 83-92%. Long-term results (one-year follow-up) are available from two studies; 62-75% did not require an appendectomy. No large RCT have yet been conducted in the paediatric population. It is therefore essential to generate high quality empirical evidence regarding this strategy in this subset of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 7-17 years\n* Radiologically confirmed simple appendicitis, defined as:\n\n 1. Clinical findings:\n\n * Unwell, but not generally ill\n * Localized tenderness in the right iliac fossa region\n * Normal/hyperactive bowel sounds\n * No guarding\n * No mass palpable\n 2. Ultrasonography:\n\n * Incompressible appendix with an outer diameter of ≥6 mm\n * Hyperaemia within the appendiceal wall\n * Without faecolith\n * Infiltration of surrounding fat\n * No signs of perforation\n * No signs of intra-abdominal abscess/phlegmon\n\nExclusion Criteria:\n\n* Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system).\n* Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:\n\n * Diffuse abdominal guarding (3 points)\n * C-Reactive Protein level more than 38 mg/L (2 points)\n * Signs on ultrasound indicative of complex appendicitis (2 points)\n * More than one day abdominal pain (2 points)\n * Temperature: more than 37.5 degree Celsius (1 point)\n* Faecolith (ultrasound)\n* Serious co-morbidity\n* Recurrent appendicitis\n* Suspicion of an underlying malignancy or inflammatory bowel disease\n* Documented type 1 allergy to the antibiotics used.'}, 'identificationModule': {'nctId': 'NCT02848820', 'acronym': 'APAC', 'briefTitle': 'Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children Aged 7-17 Years Old - Antibiotics Versus Primary Appendectomy in Children With Simple Appendicitis: APAC Study', 'orgStudyIdInfo': {'id': 'APAC2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmentin + Gentamicin', 'description': 'Initial non-operative treatment strategy reserving an appendectomy for those not responding or with recurrent disease. It consist of:\n\nClinical observation for 48 hours with administration of Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily for 48 hours. If after 48 hours the patient fulfils the predefined discharge criteria, the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days and discharge. An appendectomy is reserved for those patients with clinical deterioration, non-improvement after 72 hours or recurrent appendicitis.\n\nPain medication according to national protocol.', 'interventionNames': ['Drug: Augmentin + Gentamicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Operative treatment strategy', 'description': 'Clinical observation and semi-urgent appendectomy. Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics. Discharge if the patient fulfils the predefined discharge criteria. Pain medication according to national protocol.', 'interventionNames': ['Procedure: Appendectomy']}], 'interventions': [{'name': 'Augmentin + Gentamicin', 'type': 'DRUG', 'otherNames': ['Amoxicillin/clavulanic acid (Augmentin) + Gentamicin'], 'description': 'Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours', 'armGroupLabels': ['Augmentin + Gentamicin']}, {'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics', 'armGroupLabels': ['Operative treatment strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medical Center Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Flevoziekenhuis', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'city': 'Amstelveen', 'country': 'Netherlands', 'facility': 'Amstelland', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University medical center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Hospital', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Beverwijk', 'country': 'Netherlands', 'facility': 'Red Cross Hospital', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Maxima medical center', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Franciscus, Gasthuis en Vlietland', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Haga ziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'overallOfficials': [{'name': 'Ernst van Heurn, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pediatric Surgical Center of Amsterdam (VUmc & AMC)'}, {'name': 'Ramon Gorter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Surgical Center of Amsterdam (VUmc & AMC)'}, {'name': 'Roel Bakx, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Surgical Center of Amsterdam (VUmc & AMC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will follow'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramon Gorter', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'drs.', 'investigatorFullName': 'Ramon Gorter', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}