Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-31 @ 3:48 PM
Study NCT ID:
NCT03254056
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2017-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fascial Closure Techniques Post-Operative Pain Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2017-08-14', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative incisional pain', 'timeFrame': '24 hours after fascial closure closure', 'description': 'Visual Analog Scale'}, {'measure': 'Post-operative incisional pain', 'timeFrame': '7 days after fascial closure closure', 'description': 'Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'Time for fascial closure', 'timeFrame': 'Intraoperative', 'description': 'Minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fascial closure device', 'laparoscopic surgery', 'postoperative pain'], 'conditions': ['Post-operative Pain', 'Fascial Closure']}, 'referencesModule': {'references': [{'pmid': '28757438', 'type': 'RESULT', 'citation': 'Lyapis A, Ulrich A, LaMonica R, Kuo CL, Kaye L, Luciano D. Does the Difference in Fascial Closure Technique Affect Postoperative Pain? J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1190-1194. doi: 10.1016/j.jmig.2017.07.020. Epub 2017 Jul 27.'}, {'pmid': '19036733', 'type': 'RESULT', 'citation': 'Williams CP, Rosen MJ, Jin J, McGee MF, Schomisch SJ, Ponsky J. Objective analysis of the accuracy and efficacy of a novel fascial closure device. Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.'}, {'pmid': '8843262', 'type': 'RESULT', 'citation': 'Elashry OM, Nakada SY, Wolf JS Jr, Figenshau RS, McDougall EM, Clayman RV. Comparative clinical study of port-closure techniques following laparoscopic surgery. J Am Coll Surg. 1996 Oct;183(4):335-44.'}]}, 'descriptionModule': {'briefSummary': 'This study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. Half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl Storz, Belgium).', 'detailedDescription': "Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy. The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer the techniques in fascial closure which is more safe and cause less pain. In current study, investigators aim to compare the post-operative incisional pain in two different techniques in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-65 years\n2. Ability to understand the inform consent\n3. No conversion from laparoscopy to laparotomy\n\nExclusion Criteria:\n\n1. No-ability to understand the inform consent\n2. Conversion to laparotomy from laparoscopy'}, 'identificationModule': {'nctId': 'NCT03254056', 'briefTitle': 'Fascial Closure Techniques Post-Operative Pain Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'The Effects of Fascial Closure Techniques on Post-Operative Pain in Gynecologic Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'ZTB1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Technique', 'description': 'The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.', 'interventionNames': ['Procedure: Conventional technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Berci Technique', 'description': 'This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.', 'interventionNames': ['Procedure: Berci technique']}], 'interventions': [{'name': 'Conventional technique', 'type': 'PROCEDURE', 'description': 'Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.', 'armGroupLabels': ['Conventional Technique']}, {'name': 'Berci technique', 'type': 'PROCEDURE', 'description': 'Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.', 'armGroupLabels': ['Berci Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Women Health Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Yaprak Üstün, Prof', 'role': 'STUDY_CHAIR', 'affiliation': "University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hasan Onur Topçu', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}