A National Multicenter, Prospective, Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Autologous Flap Breast Reconstruction Following Mastectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- West China Hospital
- Enrollment
- 263
Study Overview
Brief 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. 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.
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
1. 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.
2. 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.
3. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
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.
Investigators
Du Zhenggui
deputy director
West China Hospital