Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01007318
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2009-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '1 month', 'description': '30 day morbidity and mortality'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '1 day', 'description': 'Operative time'}, {'measure': 'Efficacy', 'timeFrame': '2 days', 'description': 'Postoperative pain score'}, {'measure': 'Efficacy', 'timeFrame': '2 days', 'description': 'Postoperative functional recovery'}, {'measure': 'Efficacy', 'timeFrame': '7 days', 'description': 'Duration of postoperative hospital stay'}, {'measure': 'Efficacy', 'timeFrame': '7 days', 'description': 'Cost'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '29340826', 'type': 'DERIVED', 'citation': 'Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.', 'detailedDescription': 'Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed acute appendicitis\n\nExclusion Criteria:\n\n* Age less than 7 or more than 75 years old\n* Gangrenous appendicitis\n* Combined generalized peritonitis\n* ASA score more than 3 point\n* Pregnant women\n* Cases requiring draining tube'}, 'identificationModule': {'nctId': 'NCT01007318', 'briefTitle': 'Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis', 'orgStudyIdInfo': {'id': 'khnmc IRB 2009-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single port', 'description': 'Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.', 'interventionNames': ['Procedure: Single port laparoscopic appendectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 port', 'description': '3 port laparoscopic appendectomy was done by conventional method', 'interventionNames': ['Procedure: 3 port laparoscopic appendectomy']}], 'interventions': [{'name': 'Single port laparoscopic appendectomy', 'type': 'PROCEDURE', 'otherNames': ['single port laparoscopic surgery'], 'description': 'Single port through the transumbilical 2-cm incision', 'armGroupLabels': ['Single port']}, {'name': '3 port laparoscopic appendectomy', 'type': 'PROCEDURE', 'otherNames': ['conventional laparoscopic appendectomy'], 'description': '3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area', 'armGroupLabels': ['3 port']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University School of Medicine, Neo Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Suk Hwan Lee, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'KyungHee University School of Medicine, Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Byung Mo Kang', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}