A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorWest China Hospital
About this trial
In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term psychosocial distress. Current delayed reconstruction options are limited: traditional two-stage implant reconstruction necessitates two surgeries with associated costs and risks like infection and implant exposure, while autologous tissue transfer (e.g., TRAM/DIEP flaps), though offering superior natural aesthetics and patient satisfaction, involves extensive donor-site morbidity, prolonged recovery, and significant scarring, restricting its suitability. To address the drawbacks of both established methods-significant trauma, cost, and complexity-this study evaluates a novel technique for breast cancer patients post-mastectomy: endoscopic delayed direct-to-implant breast reconstruction. This study proposes to conduct a prospective cohort study to analyze complication rates, breast aesthetic scores, quality of life metrics, and other dimensions between delayed direct-to-implant breast reconstruction and abdominal flap breast reconstruction（DIEP and TRAM). The aim is to comprehensively evaluate the safety and clinical feasibility of endoscopic delayed direct-to-implant breast reconstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-70 years
One year after Modified Radical Mastectomy (MRM), Nipple-Sparing Mastectomy (NSM), or Skin-Sparing Mastectomy (SSM), or six months after the completion of radiotherapy, provided the local skin remains viable and sufficiently lax;
voluntary participation and ability to provide written informed consent.
Disqualifiers
History of breast surgery in which the pectoralis major muscle was removed;
Patients with serious preoperative co-morbidities and poor general condition who cannot tolerate the surgery;
Diabetes mellitus with a long history of smoking or combined poor glycemic control;
current enrollment in other clinical trials that may interfere with study outcomes;
Trial population
This technique, developed as an original procedure by our team, is performed through an axillary incision using a gas-inflated endoscopic approach. It breakthroughly integrates the traditional two-stage operation into a single-stage procedure.First, the retropectoral plane is dissected using a reverse-sequence technique. Postoperatively, intentional fluid accumulation within the implant pocket is utilized to expand the skin envelope. This achieves significantly greater tissue expansion compared to conventional tissue expanders, resulting in a reconstructed breast with a more natural contour and softer tissue consistency.Second, the entire procedure strategically avoids creating any new incisions within the breast region itself. This significantly reduces the risks of wound dehiscence and surgical site infection, while simultaneously shortening the postoperative recovery period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
263 Participants
are grouped into 2 trial groupsGroup A: delayed Endoscopic DTI Breast Reconstruction
Group B: delayed Autologous Flap Breast Reconstruction
Trial outcomes
Primary outcomes
1
breast satisfaction
Compare the BREAST-Q score（The psychosocial well-being, satisfaction with breasts, satisfaction with sexual life, and physical well-being of the chest from the BREAST-Q questionnaire's breast reconstruction module were used for evaluation. The BREAST-Q scoring system converts each patient's performance across these domains into independent scores ranging from 0 to 100, with higher scores indicating better health-related quality of life or satisfaction in the corresponding domain.）
Time frame
1 yearSecondary outcomes
1
Operative time
duration from skin incision to completion of wound closure
Time frame
during operation2
surgical-related costs
includes all direct medical expenses incurred during the operation
Time frame
during operation3
Complication outcomes
Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis
Time frame
3 months and 1 year postoperatively between the two groups.4
Doctor-report outcomes
-The Ueda scale is independently assessed by three professional healthcare workers across multiple domains, including breast size symmetry, breast shape symmetry, scar visibility, nipple-areola complex (size symmetry, position symmetry, color consistency), and inframammary fold position symmetry. Individual items are scored from 0 to 2 points, with a total score ranging from 0 to 10. Higher scores indicate better postoperative aesthetic outcomes: a total score of ≥9 is considered excellent, 7-8 good, 5-6 fair, and ≤4 poor.
Time frame
Intraoperative, 3 months, 1 year postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
Hunan Cancer Hospital
Collaborator
West China Fourth Hospital
Collaborator
West China Second University Hospital
Collaborator
Source ClinicalTrials.gov
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