Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-29 @ 8:13 AM
Study NCT ID:
NCT05890066
Status:
UNKNOWN
Last Update Posted:
2023-06-07
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-10', 'releaseDate': '2024-11-24'}], 'estimatedResultsFirstSubmitDate': '2024-11-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-28', 'size': 194892, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-05T23:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will be treated by traditional multi-port laparoscopic surgery. Aim 2 includes patients who will be treated by single-port laparoscopic surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. This is a non-blinded study where all patients and surgical teams know the treatment option.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-05-25', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'Immediately post surgery', 'description': 'Measure the amount of blood loss'}, {'measure': 'Surgical time', 'timeFrame': 'Immediately post surgery', 'description': 'How long will it take for single-port vs multi-port surgical procedures'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Within 4 weeks post surgery', 'description': 'Use visual analogue scale to measure'}, {'measure': 'Surgical complications', 'timeFrame': 'Within 4 weeks post surgery', 'description': 'Organ damages, surgical site infections, pneumoperitoneum'}, {'measure': 'Hospital stay', 'timeFrame': 'Within 4 weeks post surgery', 'description': 'How long will be the recovery time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic surgery', 'Single-port laparoscope', 'Multi-port laparoscope'], 'conditions': ['Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy', 'detailedDescription': "Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The investigators only recruit patients with ectopic pregnancy to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.\n* Agree to participate and give a consent\n\nExclusion Criteria:\n\n* Allergic reactions to anesthetics\n* Hemodynamic instability\n* Ruptured ectopic pregnancy'}, 'identificationModule': {'nctId': 'NCT05890066', 'briefTitle': 'Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Hung Vuong Hospital'}, 'officialTitle': 'Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy', 'orgStudyIdInfo': {'id': '5863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '4-port laparoscopic surgery', 'description': 'Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery'}, {'type': 'EXPERIMENTAL', 'label': '1-port laparoscopic surgery', 'description': 'Patients with ectopic pregnancy will receive 1-port laparoscopic surgery', 'interventionNames': ['Procedure: single-port laparoscopy']}], 'interventions': [{'name': 'single-port laparoscopy', 'type': 'PROCEDURE', 'description': 'Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery', 'armGroupLabels': ['1-port laparoscopic surgery']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tri B Nguyen, Doctor', 'role': 'CONTACT', 'email': 'ngoc.lam@ttu.edu.vn', 'phone': '0983739959'}, {'name': 'NGOC T LAM, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Nghiem X Huynh, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hung Vuong Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hung Vuong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Tri Bao Nguyen', 'investigatorAffiliation': 'Hung Vuong Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-24', 'type': 'RELEASE'}, {'date': '2025-01-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tri Bao Nguyen, Principle investigator, Hung Vuong Hospital'}}}}