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

NCT ID: NCT01412788

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

peri-areolar incision

Peri-areolar incision was used to carry out lumpectomy

Group Type EXPERIMENTAL

peri-areolar incision

Intervention Type PROCEDURE

peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.

traditional incision

traditional incision above tumor was used to carry out lumpectomy

Group Type ACTIVE_COMPARATOR

traditional incision

Intervention Type PROCEDURE

Traditional incision above tumor was used to carry out breast-conserving surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

peri-areolar incision

peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.

Intervention Type PROCEDURE

traditional incision

Traditional incision above tumor was used to carry out breast-conserving surgery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

the department of breast surgery of PUMCH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sun Qiang, Master

Role: STUDY_CHAIR

PUMCH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sun Qiang, Master

Role: CONTACT

86-010-88068936

Shen Songjie, Doctor

Role: CONTACT

86-010-88068936

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sun Qiang, Master

Role: primary

86-010-88068936

Shen Songjie, Doctor

Role: backup

86-010-88068936

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PUMCH- BCS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.