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Immediate Breast Reconstruction With Free Greater Omentum

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ClinicalTrials.gov Identifier: NCT03370250
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Breast Reconstruction

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : December 3, 2017
Estimated Study Completion Date : December 31, 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. severe related complication [ Time Frame: 1 year after surgery ]
    Serious adverse effect occur within 1 years after implantation


Secondary Outcome Measures :
  1. cosmetic outcome [ Time Frame: 6 months after surgery ]
    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)

  2. greater omentum survival [ Time Frame: 2 and 5 years after surgery ]
    At each follow up time point the proportion of patients with omentum transplantation will be estimated.

  3. Patient satisfaction [ Time Frame: 6months, 1 and 2 years after surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Participate in another clinicaltrial Bilateral lesions Pregnancy or lactation Greater omentum unable to extract or insufficient omentum Other surgical contraindication

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370250


Contacts
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Contact: Mei ling Huang, MD 029-84775271 huangmeiling@126.com

Locations
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China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Mei Ling Huang, MD    029-84775271    huangmeiling@126.com   
Sponsors and Collaborators
Xijing Hospital
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03370250    
Other Study ID Numbers: KY20162047-1
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
immediate breast reconstruction
free greater omentum
breast-conserving surgery
luminal breast cancer