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

• Conditions: Breast Neoplasm Female
• Interventions: Procedure: incision type

• Registration Number: NCT06258863
• Lead Sponsor: Hubei Cancer Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-07-18
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Primary Completion: 2024-07-18
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Completion: 2025-11-18

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
circumareolar incision	incision type	A total mastectomy was performed with an arc-shaped incision around the areola without limiting the distance to the nipple
inframammary fold incision	incision type	A total mastectomy was performed using an inframammary fold incision
lateral chest wall incision	incision type	A longitudinal incision was made in the lateral chest wall for a total mastectomy
radial incision	incision type	A total mastectomy was performed with a radial incision around the nipple

Primary Outcome Measures

Name	Time	Method
Breast-Q Version 2.0 Reconstruction Module	three months after surgery; six months after surgery; 1 year after surgery	The questionnaire was filled in by the subjects, and the researchers assigned scores according to the results of the questionnaire. scores of the following three parts were recorded according to the Breast-Q Version 2.0© reconstruction module, with higher scores indicating better aesthetic results, Psychosocial Well-being (0 to 100), Sexual Well-being (0 to 100), Satisfaction with Breasts (0 to 100)

Secondary Outcome Measures

Name	Time	Method
Incision-Related Complications	within 1 year after surgery	The researchers followed up the patients closely after surgery, and recorded the incidence of different postoperative incision complications of the subjects, such as infection, seroma, incision dehiscence, and capsular contracture.

Trial Locations

Locations (1)

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hongshan District, China