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A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy (DEDIA)

31. července 2026 aktualizováno: Du Zhenggui, West China Hospital

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Rekonstrukce prsu po mastektomii

Detailní popis

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.

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

263

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Zhenggui Du
Telefonní číslo: +86 13880768222
E-mail: docduzg@163.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
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.

Skupina / kohorta

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
breast satisfaction Časové okno: 1 year	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.）	1 year

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Operative time Časové okno: during operation	duration from skin incision to completion of wound closure	during operation
surgical-related costs Časové okno: during operation	includes all direct medical expenses incurred during the operation	during operation
Complication outcomes Časové okno: 3 months and 1 year postoperatively between the two groups.	Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis	3 months and 1 year postoperatively between the two groups.
Doctor-report outcomes Časové okno: Intraoperative, 3 months, 1 year postoperatively	-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.	Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes（Harris scale） Časové okno: Intraoperative, 3 months, 1 year postoperatively	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.	Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes （SCAR-Q scale） Časové okno: Intraoperative, 3 months, 1 year postoperatively	a patient-reported questionnaire consisting of 12 items, scoring only the scar on the operated side. Higher scores indicate better aesthetic outcomes.	Intraoperative, 3 months, 1 year postoperatively
patient-report outcomes (The QLQ-BR45 scale ) Časové okno: Intraoperative, 3 months, 1 year postoperatively	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	Intraoperative, 3 months, 1 year postoperatively
Aesthetic complications Časové okno: 1 years postoperatively	Capsular contracture (Baker Grade); Implant visibility/palpability (contour visibility); Rippling; Implant malposition/displacement; Animation deformity; Pectoralis major muscle pain;	1 years postoperatively

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

West China Hospital

Spolupracovníci

Hunan Cancer Hospital

West China Second University Hospital

West China Fourth Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2030

Termíny zápisu do studia

První předloženo

17. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

21. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

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