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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06258863
Other study ID # LLHBCH2023YN-046
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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