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Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach

This study is currently recruiting participants.
Verified August 2011 by Peking Union Medical College Hospital
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01412788
First received: August 7, 2011
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Procedure: peri-areolar incision
Procedure: traditional incision
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • event free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    local recurrence, regional recurrence, distant metastasis, death


Secondary Outcome Measures:
  • aesthetic outcomes [ Time Frame: two weeks, half a year and one year ] [ Designated as safety issue: No ]
    aesthetic score and QOL score

  • cost [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    operation time for the surgery, hospital stay days, costs


Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412788

Contacts
Contact: Sun Qiang, Master 86-010-88068936 sunq@medmail.com.cn
Contact: Shen Songjie, Doctor 86-010-88068936 pumcssj@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Sun Qiang, Master     86-010-88068936     sunq@medmail.com.cn    
Contact: Shen Songjie, Doctor     86-010-88068936     pumcssj@163.com    
Principal Investigator: Sunq Qiang, Master            
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Sun Qiang, Master PUMCH
  More Information

No publications provided

Responsible Party: Qiang Sun, the department of breast surgery of PUMCH
ClinicalTrials.gov Identifier: NCT01412788     History of Changes
Other Study ID Numbers: PUMCH- BCS
Study First Received: August 7, 2011
Last Updated: August 8, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
breast cancer
Breast Conserving Surgery
Peri-areolar Incision

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013