Breast Reconstruction After MastectomyDEDIANCT07602868
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
An observational study of Breast Reconstruction After Mastectomy, run by West China Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Reconstruction After Mastectomy
- How many people
- 263 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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;
- Review (clinical, imaging, pathological basis) reveals the presence of local/regional recurrence or uncontrollable distant metastasis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A National Multicenter, Prospective, Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Autologous Flap Breast Reconstruction Following Mastectomy
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.
Read the detailed description
This study is a multicenter, Prospective, randomized controlled trial. According to previous study results, the mean difference in Breast-Q breast satisfaction scores at one year postoperatively versus preoperatively was approximately 10.4 points in the autologous tissue breast reconstruction group. It is estimated that the delayed direct-to-implant breast reconstruction group will achieve a 10.4-point improvement in breast satisfaction scores one year after surgery. The difference in Breast-Q breast satisfaction scores between postoperative and preoperative assessments is non-inferior to that of autologous reconstruction. Based on historical data, the sample size was calculated for both groups, with the study hypothesis that the difference in Breast-Q breast satisfaction scores between postoperative and preoperative assessments in the delayed direct-to-implant breast reconstruction group is non-inferior to that of the delayed abdominal flap breast reconstruction group (non-inferiority margin = 3). Within each stratified group, the ratio of delayed direct-to-implant breast reconstruction group to abdominal flap reconstruction was set at 3:1. Using a one-sided test with a significance level of α = 0.05 and 80% statistical power, and assuming a 10% dropout rate, the total sample size required is 263. This includes 197 cases in the delayed direct-to-implant breast reconstruction group and 66 cases in the abdominal flap reconstruction group
- Postoperative Surgical Complications: Assessed using Any Complication, Major Complication, and Minor Complication.
- Any Complication: Any complication related to the surgical procedure occurring postoperatively. Each occurrence in a subject counts as one event. Postoperative complications can be classified into Grades I-V according to the Clavien-Dindo classification system. Complications graded Clavien-Dindo III or higher are considered Major Complications.
- Major Complication: Defined as a complication related to the reconstructive procedure that persists despite observation and conservative management, requiring surgical intervention. Examples include wound dehiscence, hemorrhage requiring surgical intervention, surgical site infection, flap ischemia/necrosis, implant rupture, prosthesis loss, etc.
- Minor Complication: Defined as a complication that resolves with observation or conservative management alone, without requiring surgical intervention. Examples include hemorrhage controllable by compression, surgical site infection controllable by oral antibiotics, seroma after drain removal, arm lymphedema, localized skin flap or NAC (nipple-areolar complex) ischemia/necrosis resolving spontaneously, implant malposition correctable by manual manipulation, animation deformity due to pectoralis major muscle division, pectoralis major muscle spasm, etc.
- Postoperative Aesthetic Outcomes and Quality of Life (QoL) Assessment: Evaluated using the following validated instruments: the BREAST-Q questionnaire (Reconstruction module), Ueda Scale, Harris Scale, QLQ-BR45 questionnaire, and SCAR-Q questionnaire.
- Aesthetic Complication Assessment: Evaluated through assessment of capsular contracture, implant visibility/palpability (contour visibility), rippling, implant malposition/displacement, and the need for secondary surgery due to aesthetic concerns.
- Capsular Contracture (Baker Classification): A complication where the fibrous capsule surrounding the implant abnormally thickens, hardens, and contracts, leading to breast firmness, distortion, and/or pain.
- Rippling: The appearance of visible wrinkles or folds on the skin surface overlying the implant.
- Implant Visibility/Palpability (Contour Visibility): A phenomenon where the edge or shape of the implant becomes visibly apparent or readily palpable beneath the skin surface. Can be graded as mild, moderate, or severe.
- Implant Malposition/Displacement: Shifting of the implant from its intended position post-implantation, resulting in abnormal breast contour or asymmetry.
- Animation Deformity: Characterized by abnormal movement, contour distortion, or functional limitation of the breast mound during pectoralis muscle contraction (e.g., during arm movement).
- Pectoralis Major Muscle Pain: Pain localized to the region of the pectoralis major muscle.
- Conditions
- Breast Reconstruction After Mastectomy
- Keywords
- delayed Endoscopic DTI, DIEP, TRAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delayed Endoscopic DTI Breast Reconstruction | 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 risk of wound dehiscence and surgical site infection while shortening the postoperative recovery period. | |
| delayed Autologous Flap Breast Reconstruction | ·DIEP Flap (Deep Inferior Epigastric Perforator Flap) The DIEP flap uses skin and fat from the lower abdomen but preserves the rectus abdominis muscle. Only the tiny perforating blood vessels (deep inferior epigastric artery and vein) that pass through the muscle are dissected and taken with the flap. These vessels are then reconnected to vessels in the chest (usually internal mammary vessels) under a microscope. Advantages: Minimal abdominal wall morbidity; lower risk of bulge or hernia; faster recovery of core strength. ·TRAM Flap (Transverse Rectus Abdominis Myocutaneous Flap) The TRAM flap also uses lower abdominal tissue, but it includes a segment of the rectus abdominis muscle (either pedicled or free). In the pedicled version, the muscle with its overlying skin/fat is tunnelled under the skin up to the chest, relying on the superior epigastric vessels. In the free TRAM, the muscle is detached and reattached to chest vessels like a DIEP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.）
Measured: 1 year
Secondary outcomes (8)
Operative time
duration from skin incision to completion of wound closure
Measured: during operation
surgical-related costs
includes all direct medical expenses incurred during the operation
Measured: during operation
Complication outcomes
Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis
Measured: 3 months and 1 year postoperatively between the two groups.
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.
Measured: Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes（Harris scale）
It consists of four grades: Excellent (bilateral breasts essentially symmetric both with and without a bra), Good (symmetric when wearing a bra but obviously asymmetric without a bra), Fair (asymmetric but not obvious even when wearing a bra), and Poor (one breast destroyed or bilateral breasts obviously asymmetric). Higher scores indicate better aesthetic outcomes.
Measured: Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes （SCAR-Q scale）
a patient-reported questionnaire consisting of 12 items, scoring only the scar on the operated side. Higher scores indicate better aesthetic outcomes.
Measured: Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes (The QLQ-BR45 scale )
assesses quality of life in breast cancer patients, including both core cancer and breast cancer-specific dimensions. It covers 4 functional domains, 9 symptom domains, and 6 single items/symptoms. The scale uses a 4-point Likert response (1="Not at All" to 4="Very Much"). Domain scores are linearly converted to a 0-100 scale; higher scores indicate better quality of life for functional domaTime Frame: Intraoper
Measured: Intraoperative, 3 months, 1 year postoperatively
Aesthetic complications
Capsular contracture (Baker Grade); Implant visibility/palpability (contour visibility); Rippling; Implant malposition/displacement; Animation deformity; Pectoralis major muscle pain;
Measured: 1 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction After MastectomyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Cancer Hospital, West China Fourth Hospital, West China Second University Hospital
- Responsible party
- Principal investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602868
- Sponsor's protocol ID
- 2025(1491)
- Acronym
- DEDIA
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided