Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT01839435
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Outpatient 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': 'D000556', 'term': 'Ambulatory Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of outpatient appendectomy', 'timeFrame': 'postoperative day 30', 'description': 'The primary endpoint corresponds to the proportion of outpatient appendectomy defined as the number of patients whose hospital length of stay is less than 12 hours.\n\nThis endpoint will be evaluated during the consult 30 day after the surgery'}], 'secondaryOutcomes': [{'measure': 'The unplanned overnight admission rate', 'timeFrame': 'postoperative day 30', 'description': 'the proportion of patients who are discharged more than 12 hours after the surgery and are thus hospitalized for at least one night'}, {'measure': 'The unexpected consultation rate', 'timeFrame': 'postoperative day 30', 'description': 'The unexpected consultation rate reflects the number of AS patients attending the emergency department for a postoperative problem.'}, {'measure': 'The hospital readmission rate', 'timeFrame': 'postoperative day 30', 'description': 'The hospital readmission rate is defined as the number of patients who are discharged from hospital after outpatient surgery but are subsequently readmitted'}, {'measure': 'the reoperation rate', 'timeFrame': 'postoperative day 30', 'description': 'the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge'}, {'measure': 'The proportion of deprogramming', 'timeFrame': 'postoperative day 30', 'description': 'The proportion of deprogramming defined as the number of reconvened patients who do not return the next day'}, {'measure': 'post-surgical pain', 'timeFrame': 'the day of the surgery prior to the discharge', 'description': 'the post-surgical pain is evaluated thanks to the Brief Pain Inventory Form'}, {'measure': 'post-surgical quality of life', 'timeFrame': 'the day of the surgery prior to the discharge', 'description': 'the post-surgical quality of life is evaluated thanks to the SF36 Form'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['appendectomy', 'acute appendicitis', 'outpatient'], 'conditions': ['Acute Appendicitis']}, 'referencesModule': {'references': [{'pmid': '22441976', 'type': 'BACKGROUND', 'citation': 'Sabbagh C, Brehant O, Dupont H, Browet F, Pequignot A, Regimbeau JM. The feasibility of short-stay laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Surg Endosc. 2012 Sep;26(9):2630-8. doi: 10.1007/s00464-012-2244-1. Epub 2012 Mar 23.'}, {'pmid': '31096041', 'type': 'RESULT', 'citation': 'Sabbagh C, Masseline L, Grelpois G, Ntouba A, Dembinski J, Regimbeau JM. Management of Uncomplicated Acute Appendicitis as Day Case Surgery: Can Outcomes of a Prospective Study Be Reproduced in Real Life? J Am Coll Surg. 2019 Sep;229(3):277-285. doi: 10.1016/j.jamcollsurg.2019.04.031. Epub 2019 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.', 'detailedDescription': "Acute appendicitis is one of the most common surgical emergencies and corresponds to an high number of admissions (about 120.000) in France. It mainly affects young adults and is associated to fewer complications and to a short length of stay. The notion of outpatient refers to a shorter hospital length to stay i.e. less than 12 hours without an overnight hospitalization. This notion came from 3 learned society recommendations' (SFCD, ACHBT, and AFCA) and has been considered as a national priority.\n\nThere is no consensus about appendectomy in an outpatient setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non complicated acute appendicitis which has been diagnosed at physical, paraclinical and morphological examination\n* Adult patient\n* Patient with sufficient understanding\n* Good compliance with medical prescription\n* Hygiene and housing equivalent to a hospitalization\n* Availability of an accompanying able to prevent the surgeon if necessary, to accompany the patient and stay at night next to him\n* Less than one hour from an health care adapted to the surgical structure\n* Quick access to a telephone\n* Patient affiliated with social protection\n\nExclusion Criteria:\n\n* complicated appendicitis\n* pregnancy or breastfeeding\n* unstable vital signs or fever\n* objective signs of diffuse peritonitis\n* ward of court or prisoners\n* Discovery of a complicated shape (severe sepsis, abscess, generalized peritonitis)\n* Discovery of an alternative diagnosis\n* Performing an associated gesture (colectomy or typhlectomy, annexectomy...)'}, 'identificationModule': {'nctId': 'NCT01839435', 'acronym': 'APPENDAMBU', 'briefTitle': 'Feasibility of Outpatient Appendectomy for Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study', 'orgStudyIdInfo': {'id': 'PI2012_843_0031'}, 'secondaryIdInfos': [{'id': '2013-A00170-45', 'type': 'OTHER', 'domain': 'ID-RCB'}, {'id': '120202B-42', 'type': 'OTHER', 'domain': 'french ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'outpatient patients', 'description': 'Outpatient surgery will be proposed to all patients', 'interventionNames': ['Procedure: outpatient surgery']}], 'interventions': [{'name': 'outpatient surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['outpatient patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Amiens University Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'jean marc regimbeau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}