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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Procedure: incision type

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Hongshan District
    • Wuhan, Hongshan District, China, 430070
      • HuBei Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
inframammary fold incision; A total mastectomy was performed using an inframammary fold incision	Procedure: incision type; 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	Procedure: incision type; 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	Procedure: incision type; 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	Procedure: incision type; Total mastectomy was performed using one of the four incision types

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incision-Related Complications	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.	within 1 year after surgery

Collaborators and Investigators

• Sponsor: Hubei Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): July 18, 2024
• Study Completion (Estimated): November 18, 2024

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Estimated): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LLHBCH2023YN-046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No