Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT06195332
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Vs. Endoscopic Transversus Abdominis Release Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay after surgery', 'timeFrame': '30 days after surgery', 'description': 'From date of operation until discharge'}], 'secondaryOutcomes': [{'measure': 'duration of operation', 'timeFrame': 'period of operation', 'description': 'time from beginning to the end of surgery'}, {'measure': 'surgical site occurrences rate', 'timeFrame': '30 days after surgery', 'description': 'incidence of all type of wound complications'}, {'measure': 'surgical site infection rate', 'timeFrame': '30 days after surgery', 'description': 'incidence of wound infection'}, {'measure': 'rate of postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'number of participants with postoperative complications'}, {'measure': 'rate of postoperative complications Clavien 3a and higher', 'timeFrame': '30 days after surgery', 'description': 'number of participants with postoperative complications Clavien 3a and higher, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al.'}, {'measure': 'Comprehensive complication index', 'timeFrame': '30 days after surgery', 'description': 'Comprehensive complication index will be calculated after verification of all complications and their classification according to Clavien, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al. Minimum (0 points) - best results, maximum (100 points) - worst result (patient death)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incisional hernia', 'eTEP', 'open TAR', 'endoscopic TAR', 'transversus abdominis release'], 'conditions': ['Incisional Hernia of Midline of Abdomen']}, 'descriptionModule': {'briefSummary': 'This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.', 'detailedDescription': 'Minimally invasive (endoscopic) transversus abdominis release (TAR) - new technique for the treatment of patients with large incisional ventral hernia. Term "endoscopic" TAR combines two minimally invasive (laparosopic or extraperitoneal (eTEP) approaches. These techniques have demonstrated significant advantages compared with open TAR in several retrospective studies. There are currently no randomized trials comparing open and endoscopic TAR operations for incisional ventral hernia repair.This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.\n\nThe sample size was determined based on a previously conducted retrospective pilot study comparing the results of open and endoscopic TAR procedures for midline incisional ventral hernia repair. The retrospective study included 133 patients with midline incisional ventral hernias who were underwent Rives-Stoppa hernia repair in combination with bilateral posterior component separation with transversus abdominis release via open (open TAR) or endoscopic (eTAR) technique in Moscow City Hospital №1 from January 2018 to December 2022. All patients were included in the study, starting from the moment of endoscopic TAR technique was introduced into the clinic. At the same time, the learning curve for the open TAR had already been reached at that time; more than 20 open TAR interventions were performed in the clinic in 2016-2017. The average hospitalization time in open TAR group was 6.7 ± 2.14 days. In endoscopic TAR group the average hospitalization time after surgery was 5.2 ± 1.65 bed days. After achieving the learning curve (20 operations) for the endoscopic TAR procedure technique average hospitalization period after surgery was 4.8 ± 1.47 days. Thus, a decrease in the duration of hospitalization in endoscopic TAR group after reaching the learning curve was noted by 28.4%. This fact, based on a retrospective pilot study, allows the investigators to assume as a hypothesis for this RCT a reduction in the duration of hospitalization during endoscopic TAR by at least 30% as a guideline for calculating the power of the study. Thus, assuming a Type I error probability α of 0.05 and a Type 2 error probability β of 0.20, it would require a total sample size of 36 patients (18 patients in each group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* midline incisional hernia\n* defect width from 8 till 12 cm\n* ASA I-III class\n* able to give informed consent\n* elective hernia repair\n* considered eligible for minimally invasive ventral hernia repair\n\nExclusion Criteria:\n\n* primary ventral hernia\n* lateral hernia with/without midline\n* refuse to give informed consent'}, 'identificationModule': {'nctId': 'NCT06195332', 'briefTitle': 'Open Vs. Endoscopic Transversus Abdominis Release Trial', 'organization': {'class': 'OTHER', 'fullName': 'City Clinical Hospital No.1 named after N.I. Pirogov'}, 'officialTitle': 'Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2907-2/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open TAR', 'description': 'Open transversus abdominis release procedure will be use as combine open procedure Rives-Stoppa hernia repair in combination with bilateral transversus abdominis release with retromuscular mesh placement', 'interventionNames': ['Procedure: open TAR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endoscopic TAR', 'description': 'Endoscopic transversus abdominis release procedure will be use as combine minimally invasive Rives-Stoppa hernia repair in combination with bilateral transversus abdominis release via endoscopic technique with retromuscular mesh placement', 'interventionNames': ['Procedure: endoscopic TAR']}], 'interventions': [{'name': 'open TAR', 'type': 'PROCEDURE', 'otherNames': ['open transversus abdominis release'], 'description': 'Participants will undergo open TAR repair according to the assigned treatment arm.', 'armGroupLabels': ['open TAR']}, {'name': 'endoscopic TAR', 'type': 'PROCEDURE', 'otherNames': ['endoscopic transversus abdominis release'], 'description': 'Participants will undergo endoscopic TAR repair according to the assigned treatment arm.', 'armGroupLabels': ['endoscopic TAR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Georgy Ivakhov, Prof', 'role': 'CONTACT', 'email': 'ivakhovsurg@gmail.com', 'phone': '+79264578568'}], 'facility': 'Clinical City Hospital #1 named after N.I. Pirogov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Alexander Sazhin, professor', 'role': 'CONTACT', 'email': 'sazhin-av@yandex.ru', 'phone': '+79163904180'}, {'name': 'Georgy Ivakhov, professor', 'role': 'CONTACT', 'phone': '+79262844224'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City Clinical Hospital No.1 named after N.I. Pirogov', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}