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

Breast Neoplasm Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06258863
• Other study ID #: LLHBCH2023YN-046
• Status: Enrolling by invitation
• Start date: July 18, 2023
• Est. completion date: November 18, 2024

Study information

• Verified date: November 2023
• Source: Hubei Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: November 18, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Procedure:
• incision type
Total mastectomy was performed using one of the four incision types

Locations

Country	Name	City	State
China	Hubei Cancer Hospital	Wuhan	Hongshan District

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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