Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA) (IBBR)
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|ClinicalTrials.gov Identifier: NCT03589924|
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Immediate IBBR+TiLoop®Bra Procedure: Immediate-delayed IBBR+TiLoop®Bra||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All patients will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicenter, Open, Prospective, Controlled Study-comparison of the Safety of Immediate One-stage Implant Based Breast Reconstruction(IBBR) Versus Two-stage Expander-Implant IBBR Augmented With TiLoop® Bra.|
|Estimated Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||October 10, 2019|
|Estimated Study Completion Date :||October 10, 2019|
Experimental: One step method
Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
Procedure: Immediate IBBR+TiLoop®Bra
Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
Active Comparator: Two step method
Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
Procedure: Immediate-delayed IBBR+TiLoop®Bra
Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra
- Rate of Complications [ Time Frame: 18 months after surgery ]The rate of complication between the two groups
- Quality of life:EORTC QLQ C30 /+ BR23 questionnaire [ Time Frame: 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.
- Patient satisfaction:Breast-Q questionnaire [ Time Frame: 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.
- Aesthetic score of reconstructed breast [ Time Frame: 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" .
- Additional surgery [ Time Frame: 18 months after surgery ]The type of additional surgery following breast reconstruction
- Angiopathology-related assessment of Tiloop bra [ Time Frame: 18 months after surgery ]The angiopathology-related assessment in immediate-delayed reconstruction group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589924
|Contact: Jiong Wuemail@example.com|
|Contact: Benlong Yangfirstname.lastname@example.org|
|Sun Yat-sen Memorial Hospital,Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 501120|
|Contact: Nanyan Rao|
|Guangdong General Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Ning Liao|
|The Second Affiliated Hospital of Zhejiang University||Recruiting|
|Zhejiang, Hangzhou, China, 310009|
|Contact: Yiding Chen|
|Jiangsu Province Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Jingping Shi|
|The first hospital of China medical university||Recruiting|
|Shengyang, Liaoning, China, 110001|
|Contact: Siyuan Han|
|Cancer Hospital/ Institute, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Jiong Wu, M.D 862164175590 email@example.com|
|Contact: Benlong Yang, Ph.D. 862164175590 firstname.lastname@example.org|
|Principal Investigator:||Jiong Wu, M.D.||Fudan University|