Prepectoral direct-to-implant breast reconstruction with complete ADM or synthetic mesh coverage – 36-Months follow-up in 200 reconstructed breasts

Abstract Objectives To assess the long-term outcome of breast reconstructions with special focus on chronic postsurgical pain (CPSP) in a larger cohort of breast cancer survivors. Methods A cross-sectional study on 121 women with mastectomy and breast reconstruction after mean 2 years 4 months follow up. The mean time from breast reconstruction to the follow-up visit was 4 years 2 months. We studied surveys on pain (Brief Pain Inventory, BPI and Douleur Neuropathique 4, DN4), quality of life (RAND-36 health survey), sleep (insomnia severity questionnaire, ISI), mood (Beck’s Depression Index, BDI; Hospital Anxiety and Depression Scale, HADS), and a detailed clinical sensory status. Patients were divided into three groups: abdominal flap (Deep inferior epigastric perforator flap, DIEP; Free transverse rectus abdominis flap, fTRAM, and Pedicled transverse rectus abdominis flap, pTRAM), dorsal flap (Latissimus dorsi flap, LD and Thoracodorsal artery perforator flap, TDAP), and other (Transverse myocutaneous gracilis flap, TMG; implant). Clinically meaningful pain was defined ≥ 4/10 on a numeric rating scale (NRS). We used patients’ pain drawings to localize the pain. We assessed preoperative pain NRS from previous data. Results 106 (87.6%) of the patients did not have clinically meaningful persistent pain. We found no statistically significant difference between different reconstruction types with regards to persistent pain (p=0.40), mood (BDI-II, p=0.41 and HADS A, p=0.54) or sleep (p=0.14), respectively. Preoperative pain prior to breast reconstruction surgery correlated strongly with moderate or severe CPSP. Conclusions Moderate to severe CPSP intensity was present in 14% of patients. We found no significant difference in the prevalence of pain across different reconstruction types. Preoperative pain associated significantly with postoperative persistent pain.

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Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽

10.1136/bmjopen-2020-044219 ◽

2021 ◽

Vol 11 (5) ◽

pp. e044219

Author(s):

J X Harmeling ◽

Kevin Peter Cinca ◽

Eleni-Rosalina Andrinopoulou ◽

Eveline M L Corten ◽

M A Mureau

Keyword(s):

Randomised Controlled Trial ◽

Breast Reconstruction ◽

Controlled Trial ◽

Capsular Contracture ◽

Tissue Expander ◽

Complication Rates ◽

Two Stage ◽

Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

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