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Randomized Controlled Trial
. 2022 Jul 8;48(4):e20210464.
doi: 10.36416/1806-3756/e20210464. eCollection 2022.

A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial)

[Article in English, Portuguese]
Ricardo Mingarini Terra  1 , Pedro Henrique Xavier Nabuco de Araujo  1 , Leticia Leone Lauricella  1 , Jose Ribas Milanese de Campos  1 , Juliana Rocha Mol Trindade  1 , Paulo Manuel Pêgo-Fernandes  1
Affiliations
Randomized Controlled Trial

A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial)

[Article in English, Portuguese]
Ricardo Mingarini Terra et al. J Bras Pneumol. .

Abstract
in English, Portuguese

Objective: To compare 90-day morbidity in patients undergoing lung lobectomy performed by either robotic-assisted thoracic surgery (RATS) or video-assisted thoracic surgery (VATS). Intraoperative complications, drainage time, length of hospital stay, postoperative pain, postoperative quality of life, and readmissions within 90 days were also compared.

Methods: This was a two-arm randomized clinical trial including patients with lung lesions (primary lung cancer or lung metastasis) who were candidates for lung lobectomy. Patients with comorbidities that precluded surgical treatment were excluded. All patients followed the same postoperative protocol.

Results: The overall sample comprised 76 patients (39 in the VATS group and 37 in the RATS group). The two groups were similar regarding gender, age, BMI, FEV1 in % of predicted, and comorbidities. Postoperative complications within 90 days tended to be more common in the VATS group than in the RATS group, but the difference was not significant (p = 0.12). However, when only major complications were analyzed, this tendency disappeared (p = 0.58). Regarding postoperative outcomes, the VATS group had a significantly higher number of readmissions within 90 days than did the RATS group (p = 0.029). No significant differences were found regarding intraoperative complications, drainage time, length of hospital stay, postoperative pain, and postoperative quality of life.

Conclusions: RATS and VATS lobectomy had similar 90-day outcomes. However, RATS lobectomy was associated with a significant reduction in the 90-day hospital readmission rate. Larger studies are necessary to confirm such a finding.(ClinicalTrials.gov identifier: NCT02292914 [http://www.clinicaltrials.gov/]).

Objetivo:: Comparar a morbidade em 90 dias de pacientes submetidos à lobectomia pulmonar por robotic-assisted thoracic surgery (RATS, cirurgia torácica robótica) ou por video-assisted thoracic surgery (VATS, cirurgia torácica videoassistida). Complicações intraoperatórias, tempo de drenagem, tempo de internação hospitalar, dor pós-operatória, qualidade de vida pós-operatória e reinternações em 90 dias também foram comparados.

Métodos:: Ensaio clínico randomizado, com dois braços, incluindo pacientes com lesões pulmonares (câncer de pulmão primário ou metástase pulmonar) candidatos à lobectomia pulmonar. Foram excluídos pacientes com comorbidades que impossibilitassem o tratamento cirúrgico. Todos os pacientes seguiram o mesmo protocolo pós-operatório.

Resultados:: A amostra total foi composta por 76 pacientes (39 no grupo VATS e 37 no grupo RATS). Os dois grupos foram semelhantes quanto a sexo, idade, IMC, VEF1 em % do previsto e comorbidades. Complicações pós-operatórias em 90 dias tenderam a ser mais frequentes no grupo VATS do que no grupo RATS, mas a diferença não foi significativa (p = 0,12). No entanto, quando analisadas apenas as complicações maiores, essa tendência desapareceu (p = 0,58). Quanto aos desfechos pós-operatórios, o grupo VATS apresentou um número significativamente maior de reinternações em 90 dias do que o grupo RATS (p = 0,029). Não foram encontradas diferenças significativas quanto a complicações intraoperatórias, tempo de drenagem, tempo de internação hospitalar, dor pós-operatória e qualidade de vida pós-operatória.

Conclusões:: A lobectomia por RATS e a lobectomia por VATS apresentaram desfechos em 90 dias semelhantes. No entanto, a lobectomia por RATS foi associada a uma redução significativa na taxa de reinternação hospitalar em 90 dias. Estudos maiores são necessários para confirmar esse achado.

(Identificador ClinicalTrials.gov: NCT02292914 [http://www.clinicaltrials.gov/])

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Conflict of interest statement

CONFLICT OF INTEREST: None declared.

Figures

Figure 1
Figure 1. Photographs of the two surgical approaches: in A, video-assisted thoracic surgery; in B, robotic-assisted thoracic surgery
Figure 2
Figure 2. Flow chart of the patient selection process. RATS: robotic-assisted thoracic surgery; VATS: video-assisted thoracic surgery; and PO: postoperative.
See this image and copyright information in PMC

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