The Comparison Between DEDTI BR and T/E BR (NCT07593846) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Comparison Between DEDTI BR and T/E BR
China412 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* Long-term smoking history or poorly controlled diabetes mellitus;
* Currently participating in other clinical trials that may affect the results of this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.