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Enrolling by invitation NCT06258863

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

Observational Breast Neoplasm Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: incision type.
Who it may be relevant to
Registry conditions: Breast Neoplasm Female. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Breast-Q Version 2.0 Reconstruction Module [Time frame: three months after surgery; six months after surgery; 1 year after surgery]
Secondary outcome measures (1)
  • Incision-Related Complications [Time frame: within 1 year after surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hubei Cancer Hospital — Wuhan

Identifiers

NCT: NCT06258863 · LLHBCH2023YN-046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗