Comparison Between Prepectoral and Subpectoral Breast Reconstruction

NCT05833659 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2023-04-27

No results posted yet for this study

Summary

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.

This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Conditions

  • Stage II Breast Cancer
  • Stage I Breast Cancer

Interventions

PROCEDURE

The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

Sponsors & Collaborators

  • Beijing Health Promotion Association

    collaborator UNKNOWN
  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • guoxuan gao, MD · Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-03-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05833659 on ClinicalTrials.gov