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

August 8, 2011 updated by: Peking Union Medical College Hospital

Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
          • Shen Songjie, Doctor
          • Phone Number: 86-010-88068936
          • Email: pumcssj@163.com
        • Principal Investigator:
          • Sunq Qiang, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
event free survival
Time Frame: 5 years
local recurrence, regional recurrence, distant metastasis, death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aesthetic outcomes
Time Frame: two weeks, half a year and one year
aesthetic score and QOL score
two weeks, half a year and one year
cost
Time Frame: 2 weeks
operation time for the surgery, hospital stay days, costs
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Sun Qiang, Master, PUMCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

August 7, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH- BCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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