NL-OMON50674
Recruiting
Not Applicable
ong-term results of two-stage breast reconstruction with polyurethane-covered versus textured implants: a prospective, multicenter randomized controlled trial - TIPI TRAIL: Textured Implants versus Polyurethane-covered Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 321
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age of 18 years or older
- •Mastectomy is performed
- •Eligible for two\-stage implant\-based breast reconstruction in accordance with
- •the Dutch national breast reconstruction guideline
- •First step of two\-stage implant\-based breast reconstruction (placement of
- •tissue expander) is successfully completed
- •Able to understand the patient information sheet, to complete questionnaires
- •and to provide written informed consent
Exclusion Criteria
- •Additional use of autologous tissues for the breast reconstruction
- •The use of acellular dermal matrix or synthetic mesh
- •Prior irradiation of the breast or an indication for postoperative
- •radiotherapy (If a patient receives radiotherapy unexpectedly at a later point
- •in time, she will be excluded retroactively)
- •Secondary reconstruction
- •Revision surgery of a previous breast reconstruction
- •Inflammatory carcinoma
- •Evidence of distant metastases
- •Active infection at the surgical field or distant locations
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Breast reconstruction: differences in outcome between two types of breast implants?Breast reconstructionbreast implantscapsular contractureNL-OMON29142Erasmus MC321
Completed
Not Applicable
Surgical outcomes following breast reconstruction in patients with and without a history of chest radiotherapy for Hodgkin lymphoma: a multicenter, matched cohort studyZ42.1C81Follow-up care involving plastic surgery of breastHodgkin lymphomaDRKS00028655Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, The Netherlands191
Completed
Not Applicable
Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancerBreast reconstruction after mastectomy for breast cancerJPRN-UMIN000018680Cellport Clinic YOKOHAMA5
Withdrawn
Not Applicable
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy RadiotherapyBreast CancerNCT01959867Integra LifeSciences Corporation
Not yet recruiting
Not Applicable
Immediate breast reconstruction after operable breast tumour surgeryHealth Condition 1: C509- Malignant neoplasm of breast of unspecified siteCTRI/2022/12/047959Rohilkhand medical college and hospital