Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
- Conditions
- Breast Cancer
- Interventions
- Procedure: Immediate IBBR+TiLoop®BraProcedure: Immediate-delayed IBBR+TiLoop®Bra
- Registration Number
- NCT03589924
- Lead Sponsor
- Jiong Wu
- Brief Summary
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
- Detailed Description
Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra.
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients.
The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra.
The current study is a randomized multicenter, open labeled, prospective, controlled study.
Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.
Based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. Consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 440
- Patients with histological proven invasive breast cancer or ductal carcinoma in situ;
- Clinical T1-T2 disease with no distant metastasis;
- Patient with clinical N0 status;
- Intent to receive NSM or SSM and implant based breast reconstruction;
- Signed consent to participate.
- Patient with severe breast ptosis;
- Patient received ipsilateral breast reduction or enlargement;
- Locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy;
- Patients enrolled in other clinical trial which may as influence the outcome;
- Patients received neo-adjuvant therapy and will receive radiotherapy.
- History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
- Patients of pregnancy or lactation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One step method Immediate IBBR+TiLoop®Bra Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225 Two step method Immediate-delayed IBBR+TiLoop®Bra Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
- Primary Outcome Measures
Name Time Method Rate of perioperative complications Start of randomization until 3 months after surgery The rate of perioperative complication between the two groups
- Secondary Outcome Measures
Name Time Method Quality of life:EORTC QLQ C30 /+ BR23 questionnaire 18 months after surgery EORTC QLQ C30 /+ BR23(EORTC breast cancer-specific quality of life) questionnaire to evaluate quality of life.
Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 1 score,"a little" for 2 score, "quit a bit" for 3 score and "very much" for 4 score. A higher score indicated a worse quality of life.Aesthetic score of reconstructed breast 18 months after surgery Harris evaluation system to evaluate patients' breast aesthetic after surgery. Harris evaluation system is a 4-staged subjective evaluation method scored as "excellent," "good," "fair," "poor" .
Angiopathology-related assessment of Tiloop bra 18 months after surgery The angiopathology-related assessment in immediate-delayed reconstruction group
Patient satisfaction:Breast-Q questionnaire 18 months after surgery Breast-Q questionnaire to evaluate patients' satisfaction Using the reconstruction module of BREAST-Q to evaluate patient-reported outcome (PRO) of the surgery.For each subtheme, one or more BREAST-Q scales were developed to examine specific aspects of patient satisfaction.
Patient responses to each scale's items are transformed through the Q-Score scoring software to provide a total scale score that ranges from 0 to 100. For all BREAST-Q scales, a higher score means greater satisfaction.Additional surgery 18 months after surgery The type of additional surgery following breast reconstruction
Trial Locations
- Locations (11)
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Hebei Cancer Hospital
🇨🇳Shijia Zhuang, Hebei, China
Guangdong Women and Children Hospital
🇨🇳Guangzhou, Guangdong, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The first hospital of China medical university
🇨🇳Shengyang, Liaoning, China
Liaoning Cancer Hospital & Insitute
🇨🇳Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Cancer Hospital/ Institute, Fudan University
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China