Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery

NCT ID: NCT06258863

Last Updated: 2025-03-17

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

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-18

Study Completion Date

2025-11-18

Brief Summary

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1. DATA COLLECTION: About 300 cases of female patients who underwent breast reconstruction at Hubei Cancer Hospital(HBCH) between February 2013 and June 2023 were retrospectively collected. The incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. The incidence of postoperative incision-related complications was recorded for different incision types;
2. DATA ORGANIZATION: Patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. The correlation of each subgroup with incision design is discussed;
3. FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score);
4. DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.

Detailed Description

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Conditions

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Breast Neoplasm Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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inframammary fold incision

A total mastectomy was performed using an inframammary fold incision

incision type

Intervention Type PROCEDURE

Total mastectomy was performed using one of the four incision types

lateral chest wall incision

A longitudinal incision was made in the lateral chest wall for a total mastectomy

incision type

Intervention Type PROCEDURE

Total mastectomy was performed using one of the four incision types

circumareolar incision

A total mastectomy was performed with an arc-shaped incision around the areola without limiting the distance to the nipple

incision type

Intervention Type PROCEDURE

Total mastectomy was performed using one of the four incision types

radial incision

A total mastectomy was performed with a radial incision around the nipple

incision type

Intervention Type PROCEDURE

Total mastectomy was performed using one of the four incision types

Interventions

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incision type

Total mastectomy was performed using one of the four incision types

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. total mastectomy
2. implant and/or autologous breast reconstruction.

Exclusion Criteria

1. No total mastectomy
2. loss of data or loss of follow-up
3. fatal cases
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hubei Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xinhong Wu, PhD

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hubei Cancer Hospital

Wuhan, Hongshan District, China

Site Status

Countries

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China

Other Identifiers

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LLHBCH2023YN-046

Identifier Type: -

Identifier Source: org_study_id

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