The Comparison Between DEDTI BR and T/E BR
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWest China Hospital
About this trial
This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.
Eligibility criteria
Qualifiers
Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;
At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;
Voluntary provision of informed consent.
Disqualifiers
Local/regional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);
Pectoralis major muscle was resected during the initial surgery;
Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;
Immunodeficiency;
Trial design
Treatments tested in this trial
- Delayed endoscopic direct-to-implant breast reconstruction
- Two-stage expander-to-implant breast reconstruction
Treatment groups
412 Participants
are divided into 2 treatment groupsSponsors and collaborators
West China Hospital
Lead sponsor
West China Second University Hospital
Collaborator
Fourth People's Hospital of Sichuan Province
Collaborator
West China Fourth Hospital
Collaborator
The Second People's Hospital of Chengdu
Collaborator
Suzhou Municipal Hospital
Collaborator
Source ClinicalTrials.gov