Breast Reconstruction Clinical Trial
Official title:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Verified date | December 2020 |
Source | First Affiliated Hospital of Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. history of PAAG breast injection; 2. appeal to remove the gel; 3. availability of complete medical records; 4. accepting the potential complications of the operation and breast deformity after gel removal. 5. agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire. Exclusion Criteria: 1. Patients who had other breast diseases; 2. Patients who failed to follow the standard diagnosis, treatment and follow-up; 3. Lost to follow-up due to various reasons or incomplete medical records; 4. Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases. |
Country | Name | City | State |
---|---|---|---|
China | Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the occurrence of a postoperative complication | Complications are defined as any adverse postoperative events directly related to gel removal or breast reconstruction surgery that require further treatment. According to the patient's main complaint, physical examination, chest radiography, breast ultrasound, breast mammography or MRI, pathological biopsy and other methods to evaluate the complications. According to the degree of complications, they were further divided into: (1) Mild complications: conservative treatment without surgical treatment. (2) Severe complications: the incidence of complications requiring reoperations or implant removal/replacement operations. | until 10 years post operation | |
Primary | The probability of reoperations | Reoperation was defined as a surgical event performed after PAAG removal alone or stage I and II reconstruction. An anticipated operation of delayed breast implantation in patients with two-stage surgery was not classified as reoperation. | until 10 years post operation | |
Secondary | Patient-reported quality of life, QOL | Patient-reported quality of life using Breast-Q score to evaluate changes in breast appearance, mental health, physical health and sexual health satisfaction before and after surgery. | until 1 year post operation | |
Secondary | Aesthetic evaluation | It was evaluated by the Aesthetic Items Scale, which was a standardized tool for evaluating the aesthetic effect of breast reconstruction surgery, which was first proposed by Visser and Brinkman. The specific method was as follows: 3 experienced plastic surgeons evaluate 5 standardized photos (front, oblique, and side) of the patient before and after surgery. All photos were organized into slides and displayed randomly, with other information hidden (Such as preoperative or postoperative state, reconstruction method used, complications or whether to perform a second operation, etc.). In order to minimize the deviation, blank slides were displayed between the photos, and the random order of the photos of each observer was different. Each doctor used a five-point Likert scale to score breast volume, shape, symmetry, scars, and nipple areola. In addition, each doctor gave an overall satisfaction score between 0-10 points based on pre- and post-operative photos. | until 1 year post operation | |
Secondary | change in patient satisfaction | Patient satisfaction consisted of four structured questions that assessed satisfaction with the size, shape, symmetry, and sensitivity of the breast. Patients were asked to rate their final result as "good", "satisfactory", "poor" or "bad". | until 1 year post operation |
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