Effect of Intraoperative Saline Fill Volume on Perioperative Outcomes in Tissue Expander Breast Reconstruction

The objectives of this study were to evaluate 1) the rate of immediate breast reconstruction; 2) the frequency of immediate tissue expander placement; and 3) to compare perioperative outcomes in patients who underwent breast reconstruction after mastectomy for breast cancer with immediate tissue expander placement (TE) with those with no reconstruction (NR). Using the Nationwide Inpatient Sample database, we examined the clinical data of patients with breast cancer who underwent mastectomy with or without immediate TE from 2006 to 2010 in the United States. A total of 344,253 patients with breast cancer underwent mastectomy in this period in the United States. Of these patients, 31 per cent had immediate breast reconstruction. We only included patients with mastectomy and no reconstruction (NR: 237,825 patients) and patients who underwent only TE placement with no other reconstruction combination (TE: 61,178 patients) to this study. Patients in the TE group had a lower overall postoperative complication rate (2.6 vs 5.5%; P < 0.01) and lower in-hospital mortality rate (0.01 vs 0.09%; P < 0.01) compared with the NR group. Fifty-three per cent of patients in the NR group were discharged the day of surgery compared with 36 per cent of patients in the TE group. Using multivariate regression analyses and adjusting patient characteristics and comorbidities, patients in the TE group had a significantly lower overall complication rate (adjusted odds ratio [AOR], 0.6) and lower in-hospital mortality (AOR, 0.2) compared with the NR group. The rate of immediate reconstruction is 31 per cent. TE alone is the most common type of immediate reconstruction (57%). There is a lower complication rate for the patients who underwent immediate TE versus the no-reconstruction cohort.

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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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