Clinical trial NCT03370250: Immediate Breast Reconstruction With Free Greater Omentum
Official title: Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Reconstruction
Keywords: immediate breast reconstruction
free greater omentum
breast-conserving surgery
luminal breast cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: severe related complication
timeFrame: 1 year after surgery
Secondary outcomes:
measure: cosmetic outcome
timeFrame: 6 months after surgery
measure: greater omentum survival
timeFrame: 2 and 5 years after surgery
measure: Patient satisfaction
timeFrame: 6months, 1 and 2 years after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References: