Immediate Breast Reconstruction With Free Greater Omentum

Breast Reconstruction Clinical Trial

Official title:

Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370250
• Other study ID #: KY20162047-1
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2017
• Last updated: December 6, 2017
• Start date: November 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2017
• Source: Xijing Hospital
• Contact: Mei ling Huang, MD
• Phone: 029-84775271
• Email: huangmeiling[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe related complication	Serious adverse effect occur within 1 years after implantation	1 year after surgery
Secondary	cosmetic outcome	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)	6 months after surgery
Secondary	greater omentum survival	At each follow up time point the proportion of patients with omentum transplantation will be estimated.	2 and 5 years after surgery
Secondary	Patient satisfaction	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.	6months, 1 and 2 years after surgery