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

NCT07602868 | Not Yet Recruiting

• 1 other identifier: 2025(1491)
• Study Type: observational
• Target: 588
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Reconstruction After Mastectomy

Keywords

delayed Endoscopic DTI; DIEP; TRAM

Outcome Measures

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.）

  1 year

Secondary Outcomes (8)

• Operative time

  during operation

• surgical-related costs

  during operation

• Complication outcomes

  3 months and 1 year postoperatively between the two groups.

• Doctor-report outcomes

  Intraoperative, 3 months, 1 year postoperatively

• patient-report outcomes（Harris scale）

  Intraoperative, 3 months, 1 year postoperatively

Study Arms (2)

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 risks of wound dehiscence and surgical site infection, while simultaneously 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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Female patients aged 18-70 years
• One year after simple mastectomy or six months after completion of radiation therapy with healthy local skin activity and skin laxity;
• voluntary participation and ability to provide written informed consent.

You may not qualify if:

• History of breast surgery in which the pectoralis major muscle was removed;
• History of abdominal surgery (both lumpectomy and open surgery)
• patients with a history of Kocher incision or complete subcostal incision;
• Patients with scarring in the midline of the lower abdomen;
• body mass index (BMI) \< 30 kg/m²;
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Central Study Contacts

Zhenggui Du

CONTACT

+86 13880768222; docduzg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-04