Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 1:12 PM
Study NCT ID:
NCT03370250
Status:
UNKNOWN
Last Update Posted:
2017-12-12
First Post:
2017-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Breast Reconstruction With Free Greater Omentum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severe related complication', 'timeFrame': '1 year after surgery', 'description': 'Serious adverse effect occur within 1 years after implantation'}], 'secondaryOutcomes': [{'measure': 'cosmetic outcome', 'timeFrame': '6 months after surgery', 'description': 'Four-point scale was formulated to evaluate the cosmetic score as excellent (size and shape of recon-structed breast are identical to the original breast); good (deformity of the reconstructed breast in-volved less than 1/4 of the original breast; fair (deformity of the reconstructed breast involves less than 1/4-1/2 of the original breast); and poor (breast deformity involves more than 1/2 of the original breast)'}, {'measure': 'greater omentum survival', 'timeFrame': '2 and 5 years after surgery', 'description': 'At each follow up time point the proportion of patients with omentum transplantation will be estimated.'}, {'measure': 'Patient satisfaction', 'timeFrame': '6months, 1 and 2 years after surgery', 'description': 'Patients also rate their level of satisfaction, with the help of a numeric rating scale (NRS: 0-10), in terms of how the outcome met up to their preoperative expectations of the arthroplasty. Finally, they will be asked whether - with their current knowledge of the outcome - they would again choose the operation if they found themselves in similar circumstances to those which prevailed preoperatively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immediate breast reconstruction', 'free greater omentum', 'breast-conserving surgery', 'luminal breast cancer'], 'conditions': ['Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been reported to be associated with good prognosis. However, for the patients with large mass or worse mass position, free greater omentum transplantation may provide a new option for breast reconstruction.', 'detailedDescription': 'Breast-conserving surgery, laparoscopic greater omentum harvest and vascular anastomosis was carried out orderly. The omentum was harvested laparoscopically, following breast-conserving surgery . Following the remove of resected omentum, the harvested greater omentum was poured by ice protection fluid from right gastric omentum artery. Besides, right arteriovenous vein of stomach omentum was dissected carefully under microscope. When operation started, front latissimus dorsi was separated from subaxillary incision, as well as the right thoracic dorsal artery and accompanying vein. Separated greater omentum was put on the subcutaneous deficient site of right breast incision and vascular pedicle was pulled through tunnel, reaching to the axillary incision. Under the help of microscope, vascular anastomosis between right stomach omentum arteriovenous and right thoracic dorsal arteriovenous was proceeded. Consequently, greater omentum was filled to shape the reconstructed breast. Finally, drainage tube and drainage strip were left at subcutaneous and subaxillary incision, respectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The research team selected the patients diagnosed with breast cancer and classified as luminal subtype who received one-sided therapeutic mastectomy and breast reconstruction with free omentum flap between January 23, 2015 and December 6, 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient aged 18 -60 years Patient diagnosed with luminal breast cancer No neoadjuvant chemotherapy previously No distant metastasis Suitable for breast conserving surgery Willing and able to give written informed consent to participate in the study including all follow-up examinations\n\nExclusion Criteria:\n\n\\- Participate in another clinicaltrial Bilateral lesions Pregnancy or lactation Greater omentum unable to extract or insufficient omentum Other surgical contraindication'}, 'identificationModule': {'nctId': 'NCT03370250', 'briefTitle': 'Immediate Breast Reconstruction With Free Greater Omentum', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'KY20162047-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Ling Huang, MD', 'role': 'CONTACT', 'email': 'huangmeiling@126.com', 'phone': '029-84775271'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Mei ling Huang, MD', 'role': 'CONTACT', 'email': 'huangmeiling@126.com', 'phone': '029-84775271'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}