This is the Scientific Surgery Archive, which contains all randomized clinical trials in surgery that have been identified by searching the top 50 English language medical journal issues since January 1998. Compiled by Jonothan J. Earnshaw, former Editor-in-Chief, BJS

Short‐term cost‐effectiveness of one‐stage implant‐based breast reconstruction with an acellular dermal matrix versus two‐stage expander‐implant reconstruction from a multicentre randomized clinical trial. BJS 2019; 106: 586-595.

Published: 5th March 2019

Authors: V. L. Negenborn, J. M. Smit, R. E. G. Dikmans, H. A. H. Winters, J. W. R. Twisk, P. Q. Ruhé et al.

Background

Implant‐based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure and its economic impact is significant. This study aimed to analyse whether a direct one‐stage IBBR with use of an acellular dermal matrix (ADM) is more cost‐effective than two‐stage (expander‐implant) breast reconstruction.

Method

The BRIOS (Breast Reconstruction In One Stage) study was an open‐label multicentre RCT in which women scheduled for skin‐sparing mastectomy and immediate IBBR were randomized between one‐stage IBBR with ADM or two‐stage IBBR. Duration of surgery and hospital stay, and visits for the primary surgery, unplanned and cosmetic procedures were recorded. Costs were estimated at an institutional level. Health status was assessed by means of the EuroQol Five Dimensions 5L questionnaire.

Results

Fifty‐nine patients (91 breasts) underwent one‐stage IBBR with ADM and 62 patients (92 breasts) two‐stage IBBR. The mean(s.d.) duration of surgery in the one‐stage group was significantly longer than that for two‐stage IBBR for unilateral (2·52(0·55) versus 2·02(0·35) h; P < 0·001) and bilateral (4·03(1·00) versus 3·25(0·58) h; P = 0·017) reconstructions. Costs were higher for one‐stage compared with two‐stage IBBR for both unilateral (€12 448 (95 per cent c.i. 10 722 to 14 387) versus €9871 (9373 to 10 445) respectively; P = 0·025) and bilateral (€16 939 (14 887 to 19 360) versus €13 383 (12 414 to 14 669); P = 0·002) reconstructions. This was partly related to the use of relatively expensive ADM. There was no difference in postoperative health status between the groups.

Conclusion

One‐stage IBBR with ADM was associated with higher costs, but similar health status, compared with conventional two‐stage IBBR. Registration number: NTR5446 (
http://www.trialregister.nl).

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