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Trial Title:
Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery
NCT ID:
NCT06258863
Condition:
Breast Neoplasm Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
incision type
Description:
Total mastectomy was performed using one of the four incision types
Arm group label:
circumareolar incision
Arm group label:
inframammary fold incision
Arm group label:
lateral chest wall incision
Arm group label:
radial incision
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.
Criteria for eligibility:
Study pop:
About 300 female patients who underwent breast reconstruction at Hubei Cancer Hospital
between January 2019 and September 2023 were collected.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430070
Country:
China
Start date:
July 18, 2023
Completion date:
November 18, 2024
Lead sponsor:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Source:
Hubei Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06258863
