Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER).

OBJECTIVE: To evaluate the non-inferiority and safety of simple hysterectomy in early stage (<2 cm) cervical cancer. METHODS: This proof-of-concept randomized phase II non-inferiority trial was performed between May 2015 and April 2018 in three oncological centers in Northeast Brazil. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IA2-IB1 cervical cancer and tumors ≤2 cm were treated with either simple or modified radical hysterectomy (Querleu-Morrow type B2). Intention-to-treat analysis was carried out. The primary endpoint was 3-year disease-free survival and secondary endpoints were overall survival, operative outcomes, adjuvant therapy, and patient's health-related quality of life (QoL). RESULTS: A total of 40 patients underwent either simple hysterectomy (n=20) or modified radical hysterectomy (n=20). All patients except three underwent open procedures (n=37/40, 92.5%). At a median follow-up of 52.1 months (IQR 43.9-60.1), 3-year disease-free survival was 95% (95% CI 68% to 99%) after simple hysterectomy and 100% (95% CI 100% to 100%) after modified radical hysterectomy (log-rank p=0.30). The corresponding 5-year overall survival rates were 90% (95% CI 64% to 97%) and 91% (95% CI 50% to 98%), respectively (log-rank p=0.46). The operative time was shorter after simple hysterectomy than after modified radical hysterectomy (150 min (IQR 137.5-180) vs 199.5 min (IQR 140-230); p=0.003), with a trend towards a longer time for vesical catheterization removal (1 day (IQR 1-1) vs 1 day (IQR 1-2); p=0.043). There was no post-operative mortality and the rates of post-operative complications were not statistically different between arms (15% and 25%; p=0.69). QoL questionnaires were received from only 17 patients (42.5%), with no major differences observed over time between the surgical arms. CONCLUSIONS: Simple hysterectomy is safe and potentially non-inferior to the radical surgery in patients with early-stage cervical cancer ≤2 cm. TRIAL REGISTRATION NUMBER: NCT02613286.

Impact of Pectoralis Nerve Block (PECS) on postoperative pain in patients submitted to mastectomy with lymphadenectomy.

OBJECTIVE: Breast cancer is the most common malignant neoplasm in women worldwide. Surgery has been traditional treatment and, generally, it´s mastectomy with lymphadenectomy, that can causes postoperative pain. Therefore, we seek to study regional anesthesic techniques that can minimize this effect, such as the interpectoral block (PECS). METHODS: randomized controlled study with 82 patients with breast cancer who underwent mastectomy with lymphadenectomy from January 2020 to October 2021 in oncology hospital. INTERVENTIONS: two randomized groups (control - exclusive general anesthesia and PECS group - received PECS block with levobupivacaine/ropivacaine and general anesthesia). We applied a questionnaire with Numeric Rating Scale for pain 24h after surgery. We used Shapiro-Wilk, Mann-Whitney and Chi-square tests, and analyzed the data in R version 4.0.0 (ReBEC). RESULTS: in the PECS group, 50% were pain-free 24h after surgery and in the control group it was 42.86%. The majority who presented pain classified it as mild pain (VAS from 1 to 3) - (42.50%) PECS group and (40.48%) control group (p=0.28). Only 17.50% consumed opioids in the PECS group, similar to the control group with 21.43%. (p=0.65). There was a low rate of complications such as PONV in both groups. In the subgroup analysis, there was no statistical difference between the groups that used levobupivacaine or ropivacaine regarding postoperative pain and opioid consumption. DISCUSSION: the studied group had a low rate of pain in the postoperative period and it influenced the statistical analysis. There wasn´t difference in postoperative pain in groups. CONCLUSION: was not possible to demonstrate better results with the association of the PECS block with total intravenous analgesia. Need further studies to assess the efficacy of the nerve block.

Brazilian Society of Surgical Oncology consensus on fertility-sparing surgery for cervical cancer.

OBJECTIVE: Several controversies remain on conservative management of cervical cancer. Our aim was to develop a consensus recommendation on important and novel topics of fertility-sparing treatment of cervical cancer. METHODS: The consensus was sponsored by the Brazilian Society of Surgical Oncology (BSSO) from March 2020 to September 2020 and included a multidisciplinary team of 55 specialists. A total of 21 questions were addressed and they were assigned to specialists' groups that reviewed the literature and drafted preliminary recommendations. Further, the coordinators evaluated the recommendations that were classified by the level of evidence, and finally, they were voted by all participants. RESULTS: The questions included controversial topics on tumor assessment, surgical treatment, and surveillance in conservative management of cervical cancer. The two topics with lower agreement rates were the role of minimally invasive approach in radical trachelectomy and parametrial preservation. Additionally, only three recommendations had <90% of agreement (fertility preservation in Stage Ib2, anti-stenosis device, and uterine transposition). CONCLUSIONS: As very few clinical trials have been developed in surgery for cervical cancer, most recommendations were supported by low levels of evidence. We addressed important and novel topics in conservative management of cervical cancer and our study may contribute to literature.

Impact of Pectoralis Nerve Block (PECS) on postoperative pain in patients submitted to mastectomy with lymphadenectomy / Impacto do Bloqueio Peitoral (PEC) na dor pós-operatória em pacientes submetidos a mastectomia com linfadenectomia

ABSTRACT Objective: Breast cancer is the most common malignant neoplasm in women worldwide. Surgery has been traditional treatment and, generally, it´s mastectomy with lymphadenectomy, that can causes postoperative pain. Therefore, we seek to study regional anesthesic techniques that can minimize this effect, such as the interpectoral block (PECS). Methods: randomized controlled study with 82 patients with breast cancer who underwent mastectomy with lymphadenectomy from January 2020 to October 2021 in oncology hospital. Interventions: two randomized groups (control - exclusive general anesthesia and PECS group - received PECS block with levobupivacaine/ropivacaine and general anesthesia). We applied a questionnaire with Numeric Rating Scale for pain 24h after surgery. We used Shapiro-Wilk, Mann-Whitney and Chi-square tests, and analyzed the data in R version 4.0.0 (ReBEC). Results: in the PECS group, 50% were pain-free 24h after surgery and in the control group it was 42.86%. The majority who presented pain classified it as mild pain (VAS from 1 to 3) - (42.50%) PECS group and (40.48%) control group (p=0.28). Only 17.50% consumed opioids in the PECS group, similar to the control group with 21.43%. (p=0.65). There was a low rate of complications such as PONV in both groups. In the subgroup analysis, there was no statistical difference between the groups that used levobupivacaine or ropivacaine regarding postoperative pain and opioid consumption. Discussion: the studied group had a low rate of pain in the postoperative period and it influenced the statistical analysis. There wasn´t difference in postoperative pain in groups. Conclusion: was not possible to demonstrate better results with the association of the PECS block with total intravenous analgesia. Need further studies to assess the efficacy of the nerve block.

RESUMO Introdução: o câncer de mama é a neoplasia maligna mais comum em mulheres no mundo. A cirurgia tem sido o tratamento tradicional e, geralmente consiste em mastectomia com linfadenectomia, podendo causar dor pós-operatória. Por isso, buscamos estudar técnicas anestésicas regionais que possam minimizar esse efeito, como o bloqueio interpeitoral (PEC). Métodos: estudo controlado randomizado com 82 pacientes com câncer de mama submetidos à mastectomia com linfadenectomia de Janeiro de 2020 a Outubro de 2021, em hospital oncológico. Intervenções: dois grupos randomizados (controle - anestesia geral exclusiva e grupo PECS - anestesia geral e bloqueio PEC com levobupivacaína/ropivacaína). Aplicou-se um questionário com Escala Visual Analógica da dor 24h pós-cirurgia. Utilizamos os testes de Shapiro-Wilk, Mann-Whitney e Quiquadrado e analisamos os dados em R versão 4.0.0. Estudo registrado em Ensaios Clínicos Brasileiros (REBec). Resultados: no grupo PEC, 50% não apresentava dor 24 horas após a cirurgia enquanto no grupo controle, 42,86% negava quadro álgico. A maioria que apresentou dor classificou-a como dor leve (EVA de 1 a 3) - (42,50%) grupo PEC e (40,48%) controle (p=0,28). Apenas 17,50% consumiram opioides no grupo PEC, semelhante ao grupo controle com 21,43%. (p=0,65), (17,50%) grupo PEC e (21,43%) grupo controle (p=0,65). Houve baixo índice de complicações como PONV (náuseas, vômitos, cefaleia) em ambos os grupos. Na análise de subgrupo, não houve diferença estatística entre os grupos que usaram Levobupivacaína ou Ropivacaína quanto a dor pós-operatória e o consumo de opioides. Discussão: o grupo estudado apresentou baixa taxa de dor no pós-operatório e isso influenciou na análise estatística. Não houve diferença estatística quanto a dor pós-operatória entre grupos. Conclusão: não foi possível demonstrar melhores resultados com a associação do bloqueio PEC com analgesia intravenosa total. São necessários novos estudos para avaliar a eficácia do bloqueio anestésico no intraoperatório e pós-operatório.

[Transhiatal versus transthoracic esophagectomy: experience of the Brazilian National Cancer Institute]. / Esofagectomia trans-hiatal versus transtorácica: experiência do Instituto Nacional do Câncer (INCA).

OBJECTIVE: Analyses of morbidity, mortality and overall survival after transhiatal (TH) or transthoracic (TT) esophagectomy. METHODS: Retrospective non randomized study of 68 patients with esophagus neoplasia operated in the Brazilian National Cancer Institute between 1997 and 2005. We divided in two groups: Group 1--TH (33 patients); and Group 2--TT (35 patients). RESULTS: The mean age was 40.7 years old (25-74 years old), being 73.5% male. Middle third tumors predominated in Group 2 (48.6% vs. 21.2%, p = 0,02). The mean of dissected lymph nodes was biggest in Group 2 (21.6 vs. 17.8 lymph nodes, p = 0.04), however without difference in number of metastatic lymph nodes (4.1 vs. 3.9 linfonodos, p = 0.85). The mean of operative time was higher in Group 2 (410 vs. 270 minutes, p = 0.001). Also the mean of length of stay was higher in Group 2 (19 vs. 14 days, p = 0.001). The operative morbidity was 50%, without statistical difference between the groups (42.4% vs. 57.1%, p = 0,23). Esophageal leakage occurred in 13.2% of cases, also without statistical difference (9.1% vs. 17.1%, p = 0.23). The mortality was 5.8% (04 patients), without statistical difference (1.4% vs. 4.4%, p = 0,83). CONCLUSION: In our study, the morbidity and mortality showed no statistical difference in relation to the access performed, although higher operative time and length of stay were observed in TT access. The 3 and 5-years overall survival also were biggest in TT access, probably due to the biggest frequency of patients on initial stages between the submitted to the TT access.

Esofagectomia trans-hiatal versus transtorácica: experiência do Instituto Nacional do Câncer (INCA) / Transhiatal versus transthoracic esophagectomy: experience of the Brazilian National Cancer Institute

OBJETIVO: Analisar comparativamente a morbimortalidade e sobrevida após esofagectomia trans-hiatal (TH) ou transtorácica (TT). METODOS: Estudo retrospectivo não randomizado de 68 pacientes com neoplasia de esôfago operados no INCA entre 1997 e 2005, divididos em dois grupos: 1 - TH (33 pacientes); e 2 - TT (35 pacientes). RESULTADOS: A idade média foi 40,7 anos (25 - 74 anos), sendo 73,5 por cento homens. Tumores do 1/3 médio predominaram no Grupo 2 (48,6 por cento versus 21,2 por cento, p = 0,02). A média de linfonodos dissecados foi maior no Grupo 2 (21,6 versus 17,8 linfonodos, p = 0,04), porém sem diferença no número de linfonodos metastáticos (4,1 versus 3,9 linfonodos, p = 0,85). O tempo cirúrgico médio foi maior no Grupo 2 (410 versus 270 minutos, p = 0,001). O tempo médio de internação também foi maior no Grupo 2 (19 versus 14 dias, p = 0,001). A morbidade operatória foi 50 por cento, sem diferença significativa (42,4 por cento versus 57,1 por cento, p = 0,23). Fístula esofágica ocorreu em 13,2 por cento, sem diferença significativa (9,1 por cento versus 17,1 por cento, p = 0,23). A mortalidade foi 5,8 por cento (04 pacientes), sem diferença significativa (1,4 por cento versus 4,4 por cento, p = 0,83). CONCLUSÃO: Neste estudo, a morbimortalidade não apresentou diferença em relação à via de acesso para a esofagectomia, apesar do maior tempo cirúrgico e de permanência hospitalar na via TT. A sobrevida global em 3 e 5 anos também foi maior na TT, possivelmente devido a maior freqüência de estágios iniciais em pacientes submetidos à transtorácica.

OBJECTIVE: Analyses of morbidity, mortality and overall survival after transhiatal (TH) or transthoracic (TT) esophagectomy. METHODS: Retrospective non randomized study of 68 patients with esophagus neoplasia operated in the Brazilian National Cancer Institute between 1997 and 2005. We divided in two groups: Group 1 - TH (33 patients); and Group 2 - TT (35 patients). RESULTS: The mean age was 40,7 years old (25 - 74 years old), being 73,5 percent male. Middle third tumors predominated in Group 2 (48,6 percent vs. 21,2 percent, p = 0,02). The mean of dissected lymph nodes was biggest in Group 2 (21,6 vs. 17,8 lymph nodes, p = 0,04), however without difference in number of metastatic lymph nodes (4,1 vs. 3,9 linfonodos, p = 0,85). The mean of operative time was higher in Group 2 (410 vs. 270 minutes, p = 0,001). Also the mean of length of stay was higher in Group 2 (19 vs. 14 days, p = 0,001). The operative morbidity was 50 percent, without statistical difference between the groups (42,4 percent vs. 57,1 percent, p = 0,23). Esophageal leakage occurred in 13,2 percent of cases, also without statistical difference (9,1 percent vs. 17,1 percent, p = 0,23). The mortality was 5,8 percent (04 patients), without statistical difference (1,4 percent vs. 4,4 percent, p = 0,83). CONCLUSION: In our study, the morbidity and mortality showed no statistical difference in relation to the access performed, although higher operative time and length of stay were observed in TT access. The 3 and 5-years overall survival also were biggest in TT access, probably due to the biggest frequency of patients on initial stages between the submitted to the TT access.