Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHenan Cancer Hospital

About this trial

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 to 70 years old;

In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;

Patients undergoing preventive mastectomy are not allowed to be included in the study;

Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;

Disqualifiers

Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;

Double breast cancer;

Bilateral breast reconstruction patients;

Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;

Trial design

Design model

Single group

Treatments tested in this trial

  • Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

    Procedure/Surgery

    Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of serious complications after breast reconstruction surgery

All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.

Time frame
One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery

Secondary outcomes

1

BREAST-Q (Breast Reconstruction Module) score

This experiment obtained subject report results from four dimensions of breast satisfaction, psychological health, physical health, and sexual health using the BREAST-Q (Breast Reconstruction Module) scoring system. BREAST-Q scoring was performed at preoperative, 1 month, 3 months, 6 months, and 12-month follow-up. The BREAST-Q score at 12 months after surgery is the main evaluation metric.

Time frame
BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up
2

Success rate of breast reconstruction

Calculation formula:The result of subtracting the number of implant removal cases caused by complications from the total number of breast reconstruction cases received, divided by the total number of reconstruction cases received.Definition of implant removal caused by complications: Refers to the removal of implants during the 12-month follow-up period due to surgical related reasons such as hematoma, serum swelling, skin flap necrosis, nipple areola necrosis, infection, incision dehiscence, implant exposure, capsule contraction, and prosthesis displacement.

Time frame
One year after surgery
3

All incidence of complications

Complications such as hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, and fat injection related complications are classified according to the Clavien Dindo scoring system, including grades I-V, and evaluated and recorded.

Time frame
On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
4

Breast cosmetic effects evaluated by doctors

The cosmetic effect of breast reconstruction is evaluated by professional doctors independent of the surgeon using the ueda scoring criteria based on patient photos.

Time frame
Before surgery,on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery

Other outcomes

Sponsors and contacts

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