Clinical Trial Radar

Aesthetic outcome evaluation--BREAST-Q scores

The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores

Preoperative (baseline), 3-month postoperative

Drainage tube indwelling duration

The duration of drainage tube indwelling refers to the total time from the postoperative insertion of the drainage tube to its removal, measured in days

Perioperative

Quality of Life--EORTC Quality of Life scores

EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms.

14 days postoperative and 3 months postoperative

wound care

The differences in the number of dressing changes and wound care procedures.

3 months postoperative

Complications

Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission

3 months, 1 year and 2 years postoperative

Aesthetic outcome evaluation--BREAST-Q scores

The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores

2 years postoperative

Quality of Life--BREAST-Q scores

The Psychosocial Well-Being, Sexual Well-Being, and Physical Well-Being of the Chest modules of BREAST-Q questionnaire are used to evaluate quality of life (QoL) outcomes. Transformed scores range from 0 to 100, with higher values indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be recorded, along with pre- to postoperative differences in transformed scores

Preoperative (baseline), 3 months and 2 years postoperative

Surgical margin involvement

Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination

2-3 weeks postoperative after paraffin-embedded pathological report available

The total volume of drainage

The volume of drainage refers to the total amount of fluid drained from the time of tube placement to the time of tube removal, measured in milliliters.

Perioperative

Aesthetic outcome evaluation--Harris score

The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).

2-year postoperative

Aesthetic outcome evaluation--Ueda score

Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented

2-year postoperative

Local Recurrence-Free Survival(LRFS)

The time interval from initiation of treatment to the first recurrence at the primary tumor site.If local recurrence appears, record the time and location of recurrence

2-year postoperative and 5-year postoperative

Disease-Free Survival(DFS)

The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location.

2-year postoperative and 5-year postoperative

Overall Survival(OS)

The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason.

2-year postoperative and 5-year postoperative