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

NCT06258863 | Enrolling By Invitation

• 1 other identifier: LLHBCH2023YN-046
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score);
4. 4.DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• Breast-Q Version 2.0 Reconstruction Module

  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)

  three months after surgery; six months after surgery; 1 year after surgery

Secondary Outcomes (1)

• Incision-Related Complications

  within 1 year after surgery

Study Arms (4)

inframammary fold incision

A total mastectomy was performed using an inframammary fold incision

Procedure: incision type

lateral chest wall incision

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

Procedure: incision type

circumareolar incision

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

Procedure: incision type

radial incision

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

Procedure: incision type

Interventions

incision type PROCEDURE

Total mastectomy was performed using one of the four incision types

circumareolar incision; inframammary fold incision; lateral chest wall incision; radial incision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

About 300 female patients who underwent breast reconstruction at Hubei Cancer Hospital between January 2019 and September 2023 were collected.

You may qualify if:

• total mastectomy
• implant and/or autologous breast reconstruction.

You may not qualify if:

• No total mastectomy
• loss of data or loss of follow-up
• fatal cases

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hongshan District, 430070, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 14, 2024
• Study Start: July 18, 2023
• Primary Completion: July 18, 2024
• Study Completion: November 18, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-11

Locations

CN (1)