Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
|ClinicalTrials.gov Identifier: NCT01412788|
Recruitment Status : Unknown
Verified August 2011 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: peri-areolar incision Procedure: traditional incision||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||January 2013|
Experimental: peri-areolar incision
Peri-areolar incision was used to carry out lumpectomy
Procedure: peri-areolar incision
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
Active Comparator: traditional incision
traditional incision above tumor was used to carry out lumpectomy
Procedure: traditional incision
Traditional incision above tumor was used to carry out breast-conserving surgery.
- event free survival [ Time Frame: 5 years ]local recurrence, regional recurrence, distant metastasis, death
- aesthetic outcomes [ Time Frame: two weeks, half a year and one year ]aesthetic score and QOL score
- cost [ Time Frame: 2 weeks ]operation time for the surgery, hospital stay days, costs
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412788
|Contact: Sun Qiang, Masteremail@example.com|
|Contact: Shen Songjie, Doctorfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Sun Qiang, Master 86-010-88068936 email@example.com|
|Contact: Shen Songjie, Doctor 86-010-88068936 firstname.lastname@example.org|
|Principal Investigator: Sunq Qiang, Master|
|Study Chair:||Sun Qiang, Master||PUMCH|