Clinical trial NCT04715802: Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Official title: Options of Breast Reconstruction Timing and Method After Removing of Polyacrylamide Hydrogel: a Propensity Score-matched Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast
Mammaplasty
Breast Reconstruction
Keywords: polyacrylamide hydrogel (PAAG)
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to the Plastic Surgery Department of the First Affiliated Hospital of Zhejiang University School of Medicine with complications after receiving PAAG injection for breast augmentation.

Brief summary: 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.

Detailed description: The primary purposes of this study are to:

1. Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
2. Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
3. Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.

The secondary purposes of this study are to：

1. Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
2. Compare the rate of postoperative complications and reoperations between the patients who had breast reconstruction with implants and patients who had primary breast augmentation with implants.
3. Further refine the algorithm for breast reconstruction in patients with PAAG injections.

Eligibility criteria: 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.

Primary outcomes:
measure: the occurrence of a postoperative complication
timeFrame: until 10 years post operation
measure: The probability of reoperations
timeFrame: until 10 years post operation
Secondary outcomes:
measure: Patient-reported quality of life, QOL
timeFrame: until 1 year post operation
measure: Aesthetic evaluation
timeFrame: until 1 year post operation
measure: change in patient satisfaction
timeFrame: until 1 year post operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: