Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:42 AM
Study NCT ID:
NCT01515293
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2012-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Incision Versus Conventional Laparoscopic Appendectomy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2012-01-23', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '23386239', 'type': 'DERIVED', 'citation': 'Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.', 'detailedDescription': 'Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected acute appendicitis\n\nExclusion Criteria:\n\n* Perforated appendicitis'}, 'identificationModule': {'nctId': 'NCT01515293', 'briefTitle': 'Single Incision Versus Conventional Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen de la Arrixaca'}, 'officialTitle': 'Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy', 'orgStudyIdInfo': {'id': 'HUV-APP-MDFB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Incision Laparoscopic Appendectomy', 'interventionNames': ['Procedure: Single Incision Laparoscopic Appendectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional appendectomy', 'description': 'Conventional appendectomy', 'interventionNames': ['Procedure: Conventional appendectomy']}], 'interventions': [{'name': 'Single Incision Laparoscopic Appendectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Single Incision Laparoscopic Appendectomy']}, {'name': 'Conventional appendectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Conventional appendectomy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dolores Frutos HUV Arrixaca', 'investigatorFullName': 'Dolores Frutos Bernal', 'investigatorAffiliation': 'Hospital Universitario Virgen de la Arrixaca'}}}}