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Comparison of the patients’ Satisfaction and the Safety of surgery in Pre-pectoral versus Subpectoral implant-based immediate Breast Reconstruction with TiLoop?Bra after Endoscopy-Assisted reverse Total Mastectomy via Axillary incision: A multicenter, Open, Prospective, Single blind, Randomized controlled Trial (ESPSIT study)

Comparison of the patients’ Satisfaction and the Safety of surgery in Pre-pectoral versus Subpectoral implant-based immediate Breast Reconstruction with TiLoop?Bra after Endoscopy-Assisted reverse Total Mastectomy via Axillary incision: A multicenter, Open, Prospective, Single blind, Randomized controlled Trial (ESPSIT study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061112
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Treated group:pre-pectoral implant-based Breast Reconstruction combined with TiLoop ? Bra
control group:sub-pectoral implant-based Breast Reconstruction combined with TiLoop ? Bra

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-70 years (including 18 and 70 years); 2. Invasive breast cancer or ductal carcinoma in situ was confirmed by preoperative pathology; 3. (before neoadjuvant chemotherapy) the maximum diameter of breast tumor <= 5cm; 4. patients with clinical cN0 and cN1 (before neoadjuvant chemotherapy); 5. No clinical or imaging evidence of distant metastasis; 6. Subcutaneous gland resection of nipple and areola complex is planned; 7. BMI<40 kg/m2; 8. patients who were allowed to undergo contralateral breast augmentation by endoscopy at the same time; 9. Implant prosthesis< 600 cc; 10. Able and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with inflammatory breast cancer; 2. skin, pectoral muscle, chest wall invasion; 3. Patients with late tumor stage and high risk of recurrence (based on multidisciplinary evaluation); 4. Breast cancer during pregnancy and lactation; 5. scars below the level of the breast papilla and previous radiotherapy history (such as radiotherapy after breast conserving surgery); 6. The patient was complicated with serious disease and poor general condition before surgery and could not tolerate surgery; 7. Immune deficiency; 8. HbA1c > 7.5%; 9. long history of smoking; 10. participating in other clinical studies and may affect participation in this study.

Design outcomes

Primary

MeasureTime frame
Cosmetic effect;Major complications;

Secondary

MeasureTime frame
minor complications;Economic cost of health;Social psychological health;Breast satisfaction;Sexual satisfaction;Chest health;Capsular contracture rate;

Countries

China

Contacts

Public ContactZhenggui Du

West China Hospital, Sichuan University

docduzg@163.com+86 18980605774; +86 13880768222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026