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Randomized Controlled Trial
. 2020 Oct;4(5):811-820.
doi: 10.1002/bjs5.50324. Epub 2020 Aug 6.

Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial

F Lohmander  1   2 , J Lagergren  3   2 , H Johansson  4 , P G Roy  5 , J Frisell  2 , Y Brandberg  4
Affiliations
Randomized Controlled Trial

Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial

F Lohmander et al. BJS Open. 2020 Oct.

Abstract
in English, Spanish

Background: Acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) aims to improve cosmetic outcomes. Six-month data are presented from a randomized trial evaluating whether IBBR with ADM provides higher health-related quality of life (HRQoL) and patient-reported cosmetic outcomes compared with conventional IBBR without ADM.

Methods: In this multicentre open-label RCT, women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK were allocated randomly (1 : 1) to IBBR with or without ADM. HRQoL, a secondary endpoint, was measured as patient-reported outcome measures (PROMs) using three validated instruments (EORTC-QLQC30, QLQ-BR23, QLQ-BRR26) at baseline and 6 months.

Results: Between 24 April 2014 and 10 May 2017, 135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis. At 6 months after surgery, patient-reported HRQoL, measured with generic QLQ-C30 or breast cancer-specific QLQ-BR23, was similar between the groups. For patient-reported cosmetic outcomes, two subscale items, cosmetic outcome (8·66, 95 per cent c.i. 0·46 to 16·86; P = 0·041) and problems finding a well-fitting bra (-13·21, -25·54 to -0·89; P = 0·038), yielded higher scores in favour of ADM, corresponding to a small to moderate clinical difference. None of the other 27 domains measured showed any significant differences between the groups.

Conclusion: IBBR with ADM was not superior in terms of higher levels of HRQoL compared with IBBR without ADM. Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months. Registration number: NCT02061527 ( www.clinicaltrials.gov).

Antecedentes: Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant’based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health’related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM. MÉTODOS: Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant’based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health’related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM.

Resultados: Entre el 24 de abril de 2014 y el 10 de mayo de 2017, se consideraron 135 mujeres, de las que se incluyeron en el análisis final 64 con ADM y 65 sin ADM. A los 6 meses de la intervención, la HRQOL medida con los cuestionarios QLQ-C30 (genérico) y QLQ-BR23 (específico para el cáncer de mama) fue similar en los dos grupos. Con respecto a los resultados estéticos percibidos por la paciente, se obtuvieron mejores puntuaciones a favor de la ADM en dos sub-escalas: “resultado estético” (8,66, i.c. del 95%, 0,46-16,86, P = 0,041) y “problemas para encontrar un sujetador que se ajuste bien” −13,21 (i.c. del 95% −25, 54 a −0,89, P = 0,038), lo que representa una diferencia clínica pequeña-moderada. No hubo diferencias significativas entre los dos grupos en ninguno de los otros 27 dominios medidos. CONCLUSIÓN: No se pudo demostrar la superioridad de la IBBR con ADM mediante variables relacionadas con la calidad de vida. Aunque se obtuvieron mejores puntuaciones con la ADM en dos sub-escalas de los PROMs, no hubo diferencias entre ambos tratamientos en la mayoría de las variables estéticas a los 6 meses.

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Figures

Fig. 1
Fig. 1
CONSORT diagram for the trial IBBR, implant‐based breast reconstruction; ADM, acellular dermal matrix.
Fig. 2
Fig. 2
Forest plot illustrating mean differences in outcomes for the reconstruction‐specific EORTC‐BRR26 questionnaire at 6 months Mean differences (MDs) with crude estimates (no baseline) are shown with 95 per cent confidence intervals. *Small clinical difference; †moderate clinical difference 22 . ‡Wald test.
See this image and copyright information in PMC

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