Clinical trial · Interventional
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials. This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| peri-areolar incision | Procedure | — | UNRESOLVED |
| traditional incision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- peri-areolar incision
- description
- Peri-areolar incision was used to carry out lumpectomy
- interventionNames
- Procedure: peri-areolar incision
- type
- ACTIVE_COMPARATOR
- label
- traditional incision
- description
- traditional incision above tumor was used to carry out lumpectomy
- interventionNames
- Procedure: traditional incision
Primary outcomes (1)
- measure
- event free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * patients desire for breast conserving surgery; * fulfills criteria for breast conserving surgery; * the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola; * patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included; Exclusion Criteria: * patients not suitable for breast conserving surgery; * skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing; * male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure; * Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
References
Publications (0)
Data not yet available