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1.
Trends Parasitol ; 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39013660

RESUMO

The protozoan parasites Plasmodium, Leishmania, and Trypanosoma are transmitted by hematophagous insects and cause severe diseases in humans. These infections pose a global threat, particularly in low-resource settings, and are increasingly extending beyond the current endemic regions. Tropism of parasites is crucial for their development, and recent studies have revealed colonization of noncanonical tissues, aiding their survival and immune evasion. Despite receiving limited attention, cumulative evidence discloses the respiratory system as a significant interface for host-pathogen interactions, influencing the course of (co)infection and disease onset. Due to its pathophysiological and clinical implications, we emphasize that further research is needed to better understand the involvement of the respiratory system and its potential to improve prevention, diagnosis, treatment, and interruption of the chain of transmission.

2.
J Surg Oncol ; 2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38843101

RESUMO

This is a video vignette of a 57-year-old asymptomatic female patient. The patient underwent a screening colonoscopy which revealed a 10 mm scar in the rectum. Biopsy resulted in a well-differentiated tubular adenocarcinoma. Computed tomography and pelvic magnetic resonance imaging confirmed tumor characteristics without distant or lymph nodal metastasis. A minimally invasive robotic transanal resection using the Da Vinci Xi platform was performed, achieving full-thickness lesion excision with uneventful recovery. Histopathology revealed intramucosal adenocarcinoma with free margins. Local resection is advocated for selected T1 lesions and demands a thorough preoperative assessment. Robotic-assisted surgery presents a valuable alternative for early rectal adenocarcinoma management.

3.
Oncol Ther ; 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38829416

RESUMO

INTRODUCTION: RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption. METHODS: In this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01-11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment. RESULTS: The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group. CONCLUSION: This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04928573. June 16, 2021, "retrospectively registered".

4.
Artigo em Inglês | MEDLINE | ID: mdl-38851990

RESUMO

BACKGROUND: Neoadjuvant radiation and oxaliplatin-based systemic therapy (total neoadjuvant therapy-TNT) have been shown to increase response and organ-preservation rates in localized rectal cancer. However, trials have been heterogeneous regarding treatment protocols and few have used a watch-and-wait (WW) approach for complete responders. This trial evaluates if conventional long-term chemoradiation followed by consolidation of FOLFIRINOX increases complete response rates and the number of patients managed by WW. METHODS: This was a pragmatic randomized phase II trial conducted in 2 Cancer Centers in Brazil that included patients with T3+ or N+ rectal adenocarcinoma. After completing a long-course 54 Gy chemoradiation with capecitabine patients were randomized 1:1 to 4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 150, 5-FU 2400)-TNT-arm-or to the control arm, that did not include further neoadjuvant treatment. All patients were re-staged with dedicated pelvic magnetic resonance imaging and sigmoidoscopy 12 weeks after the end of radiation. Patients with a clinical complete response were followed using a WW protocol. The primary endpoint was complete response: clinical complete response (cCR) or pathological response (pCR). RESULTS: Between April 2021 and June 2023, 55 patients were randomized to TNT and 53 to the control arm. Tumors were 74% stage 3, median distance from the anal verge was 6 cm, 63% had an at-risk circumferential margin, and 33% an involved sphincter. The rates of cCR + pCR were (31%) for TNT versus (17%) for controls (odds ratio 2.19, CI 95% 0.8-6.22 P = .091) and rates of WW were 16% and 9% (P = ns). Median follow-up was 8.1 months and recurrence rates were 16% versus 21% for TNT and controls (P = ns). CONCLUSIONS: TNT with consolidation FOLFIRINOX is feasible and has high response rates, consistent with the current literature for TNT. This trial was supported by a grant from the Brazilian Government (PROADI-SUS - NUP 25000.164382/2020-81).

5.
Einstein (Sao Paulo) ; 22: eAO0575, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38922219

RESUMO

OBJECTIVE: Currently programmed cell death protein 1 (PD-1) inhibitors in combination with other therapies are being evaluated to determine their efficacy in cancer treatment. However, the effect of PD-ligand (L) 1 expression on disease outcomes in stage III (EC III) non-small cell lung cancer is not completely understood. Therefore, this study aimed to assess the influence of PD-L1 expression on the outcomes of EC III non-small cell lung cancer. METHODS: This study was conducted on patients diagnosed with EC III non-small cell lung cancer who underwent treatment at a tertiary care hospital. PD-L1 expression was determined using immunohistochemical staining, all patients expressed PD-L1. Survival was estimated using the Kaplan-Meier method. Relationships between variables were assessed using Cox proportional regression models. RESULTS: A total of 49 patients (median age=69 years) with EC III non-small cell lung cancer and PD-L1 expression were evaluated. More than half of the patients were men, and most were regular smokers. The patients were treated with neoadjuvant chemotherapy, surgery, or sequential or combined chemotherapy and radiotherapy. The median progression-free survival of the entire cohort was 14.2 months, and the median overall survival was 20 months. There was no significant association between PD-L1 expression and disease progression, clinical characteristics, or overall survival. CONCLUSIONS: PD-L1 expression was not correlated with EC III non-small cell lung cancer outcomes. Whether these findings differ from the association with immune checkpoint inhibitors remains to be addressed in future studies.


Assuntos
Antígeno B7-H1 , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Estadiamento de Neoplasias , Humanos , Carcinoma Pulmonar de Células não Pequenas/metabolismo , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/terapia , Masculino , Feminino , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/metabolismo , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/mortalidade , Antígeno B7-H1/análise , Antígeno B7-H1/metabolismo , Estudos Retrospectivos , Idoso , Pessoa de Meia-Idade , Prognóstico , Estimativa de Kaplan-Meier , Imuno-Histoquímica , Idoso de 80 Anos ou mais , Biomarcadores Tumorais/análise , Biomarcadores Tumorais/metabolismo , Adulto
6.
J Surg Oncol ; 2024 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-38630905

RESUMO

BACKGROUND AND OBJECTIVES: This study evaluates the Tri-Staple™ technology in colorectal anastomosis. METHODS: Patients who underwent rectosigmoidectomy between 2016 and 2022 were retrospectively evaluated and divided into two groups: EEA™ (EEA) or Tri-Staple™ (Tri-EEA). The groups were matched for age, sex, American Society of Anesthesiologists (ASA), and neoadjuvant radiotherapy using propensity score matching (PSM). RESULT: Three hundred and thirty-six patients were included (228 EEA; 108 Tri-EEA). The groups were similar in sex, age, and neoadjuvant therapy. The Tri-EEA group had fewer patients with ASA III/IV scores (7% vs. 33%; p < 0.001). The Tri-EEA group had a lower incidence of leakage (4% vs. 11%; p = 0.023), reoperations (4% vs. 12%; p = 0.016), and severe complications (6% vs. 14%; p = 0.026). There was no difference in complications, mortality, readmission, and length of stay. After PSM, 108 patients in the EEA group were compared with 108 in the Tri-EEA group. The covariates sex, age, neoadjuvant radiotherapy, and ASA were balanced, and the risk of leakage (4% vs. 12%; p = 0.04), reoperation (4% vs. 14%; p = 0.014), and severe complications (6% vs. 15%; p = 0.041) remained lower in the Tri-EEA group. CONCLUSION: Tri-Staple™ reduces the risk of leakage in colorectal anastomosis. However, this study provides only insights, and further research is warranted to confirm these findings.

7.
Ann Vasc Surg ; 2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38582213

RESUMO

BACKGROUND: Numerous risk factors for lower limb amputations are known; however, this study aimed to identify risk factors for re-amputation in patients within 6 months from an initial lower limb amputation procedure. METHODS: This single-center retrospective cohort study was performed at the Hospital Regional Hans Dieter Schmidt in Brazil. The study included patients who were aged at least 18 years and had undergone lower limb amputation between 2013 and 2022. Patients who died while hospitalized and patients who were lost to follow-up after hospital discharge were excluded from the study. Patient age, sex, number of amputations, revision time, comorbidities, and potential risk factors were extracted from the physical therapy service database and electronic medical records of the hospital. Chi-squared test and student's t-test were used to identify statistical significance. RESULTS: A total of 652 patients were included, of which 35.2% (230) patients underwent re-amputation within 6 months of the first operation. We found that dialysis (P = 0.004; odds ratio [OR] 8.36, 95% confidence interval [CI] 3.09-20.5), smoking (P = 0.004; OR 1.67, 95% CI 1.18-2.35), and hypertension (P = 0.02; OR 1.55, 95% CI 1.09-2.19) were predictive factors for re-amputation within 6 months of lower limb amputation. CONCLUSIONS: Therefore, it is important to intervene early and provide additional support to patients undergoing lower limb amputation with these risk factors to reduce the potential for re-amputation in the future.

9.
Colorectal Dis ; 26(5): 940-948, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38590005

RESUMO

AIM: The aim of this work was to compare lymph node (LN) yield in patients operated on for right colon cancer (RCC) using a laparoscopic approach between those receiving an intracorporeal (ICA) or extracorporeal anastomosis (ECA). METHOD: This is a retrospective multicentre study involving patients operated on for RCC in nine tertiary referral centres in Latin America during a 2-year period. The main comparative outcome between groups was the number of LNs harvested between groups. RESULTS: The study included 416 patients, 261 (62.7%) in the ECA group and 155 (37.3%) in the ICA group. Patients in the ECA group were elderly (66 vs. 61 years, p < 0.001). Patients receiving an ICA achieved a significantly higher LN yield than those receiving an ECA (24 vs. 18, p < 0.001). This group also had a lower percentage of patients achieving a substandard LN yield (<12 LNs) (10% vs. 24.8%, p = 0.001) and more patients achieving a high number of harvested LNs (>32 LNs) (15.5% vs. 8.3%, p = 0.039). In the multivariate analysis, ICA was independently related to the primary outcome (LN yield) (OR 3.28, p = 0.027, 95% CI 1.14-9.38). CONCLUSION: In this retrospective study, patients operated on for RCC who received an ICA achieved a higher LN yield. Further studies are needed to reconfirm these findings, and also to find an explanation for these results.


Assuntos
Anastomose Cirúrgica , Neoplasias do Colo , Laparoscopia , Excisão de Linfonodo , Linfonodos , Humanos , Estudos Retrospectivos , Masculino , Feminino , Neoplasias do Colo/cirurgia , Neoplasias do Colo/patologia , Pessoa de Meia-Idade , Idoso , Excisão de Linfonodo/métodos , Excisão de Linfonodo/estatística & dados numéricos , Anastomose Cirúrgica/métodos , Laparoscopia/métodos , Laparoscopia/estatística & dados numéricos , Linfonodos/patologia , Linfonodos/cirurgia , América Latina , Colectomia/métodos , Metástase Linfática
11.
Surg Endosc ; 38(5): 2571-2576, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38498211

RESUMO

BACKGROUND: Evidence regarding the outcomes benefits of robotic approach, when compared to a laparoscopic approach, in colectomy remain limited. OBJECTIVE: This study aimed to analyze the value of robotic approach compared to laparoscopic approach in minimally invasive colectomy. DESIGN: Cohort study of the National Surgical Quality Improvement Program (NSQIP). SETTING: This study included data from the NSQIP from 1/2016 to 12/2021. PATIENT: Adult patients undergoing minimally invasive (laparoscopic or robotic) colorectal surgery. INTERVENTION: Robotic versus laparoscopic colectomy. OUTCOME MEASURES: Risk ratios for the incidence of medical and surgical morbidity and overall mortality. RESULTS: Compared to laparoscopic, robotic colectomy was associated with a significant decrease in postoperative morbidity [RR 0.84 (95%CI 0.72-0.96), P < 0.001], a significant reduction in postoperative mortality [RR 0.83 (95%CI 0.79-0.90), P 0.010)], and in post operative ileus [RR: 0.80 (95%CI 0.75-0.84), P < 0.001]. Yet, robotic approach was associated with a significant increase in total operative time despite a significant decrease in total length of stay. No benefit was observed regarding anastomotic leak. LIMITATIONS: Observational nature of the study cannot exclude residual bias. CONCLUSIONS: In this prospective cohort from the NSQIP, robotic colectomy was associated with a significant reduction in postoperative ileus, unplanned conversion to open surgery, morbidity, and overall mortality when compared to laparoscopic colectomy.


Assuntos
Colectomia , Laparoscopia , Complicações Pós-Operatórias , Melhoria de Qualidade , Procedimentos Cirúrgicos Robóticos , Humanos , Colectomia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Laparoscopia/métodos , Laparoscopia/estatística & dados numéricos , Feminino , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Idoso , Duração da Cirurgia , Estados Unidos/epidemiologia , Tempo de Internação/estatística & dados numéricos , Adulto , Resultado do Tratamento
12.
Colorectal Dis ; 26(4): 709-715, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38385895

RESUMO

AIM: The role of bowel preparation before colectomy in Crohn's disease patients remains controversial. This retrospective analysis of a prospective cohort study aimed to investigate the clinical outcomes associated with mechanical and antibiotic colon preparation in patients diagnosed with Crohn's disease undergoing elective colectomy. METHOD: Data were collected from the American College of Surgeons National Surgical Quality Improvement Program participant user files from 2016 to 2021. A total of 6244 patients with Crohn's disease who underwent elective colectomy were included. The patients were categorized into two groups: those who received combined colon preparation (mechanical and antibiotic) and those who did not receive any form of bowel preparation. The primary outcomes assessed were the rate of anastomotic leak and the occurrence of deep organ infection. Secondary outcomes included all-cause short-term mortality, clinical-related morbidity, ostomy creation, unplanned reoperation, operative time, hospital length of stay and ileus. RESULTS: Combined colon preparation was associated with significantly reduced risks of anastomotic leak (relative risk 0.73, 95% CI 0.56-0.95, P = 0.021) and deep organ infection (relative risk 0.68, 95% CI 0.56-0.83, P < 0.001). Additionally, patients who underwent colon preparation had lower rates of ostomy creation, shorter hospital stays and a decreased incidence of ileus. However, there was no significant difference in all-cause short-term mortality or the need for unplanned reoperation between the two groups. CONCLUSION: This study shows that mechanical and antibiotic colon preparation may have clinical benefits for patients with Crohn's disease undergoing elective colectomy.


Assuntos
Fístula Anastomótica , Colectomia , Doença de Crohn , Bases de Dados Factuais , Procedimentos Cirúrgicos Eletivos , Cuidados Pré-Operatórios , Humanos , Colectomia/métodos , Colectomia/efeitos adversos , Doença de Crohn/cirurgia , Feminino , Masculino , Procedimentos Cirúrgicos Eletivos/métodos , Adulto , Estudos Retrospectivos , Cuidados Pré-Operatórios/métodos , Pessoa de Meia-Idade , Fístula Anastomótica/etiologia , Fístula Anastomótica/epidemiologia , Fístula Anastomótica/prevenção & controle , Catárticos/administração & dosagem , Estudos Prospectivos , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Duração da Cirurgia , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Melhoria de Qualidade
14.
Hernia ; 27(6): 1397-1413, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37679548

RESUMO

BACKGROUND: Mesh repair in incarcerated or strangulated groin hernia is controversial, especially when bowel resection is required. We aimed to perform a meta-analysis comparing mesh and non-mesh repair in patients undergoing emergency groin hernia repair. METHODS: We performed a literature search of databases to identify studies comparing mesh and primary suture repair of patients with incarcerated or strangulated inguinal or femoral hernias who underwent emergency surgery. Postoperative outcomes were assessed by pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: 1095 studies were screened and 101 were thoroughly reviewed. Twenty observational studies and four randomized controlled trials comprising 12,402 patients were included. We found that mesh-based repair had reduced recurrence (OR 0.36; 95% CI 0.19, 0.67; P = 0.001; I2 = 35%), length of hospital stay (OR - 1.02; 95% CI - 1.87, - 0.17; P = 0.02; I2 = 94%) and operative time (OR - 9.21; 95% CI - 16.82, - 1.61; P = 0.02; I2 = 95%) without increasing surgical site infection, mortality or postoperative complications such as seroma, chronic, ileus or urinary retention. In the subgroup analysis of patients that underwent bowel resection, we found that mesh repair was associated with an increased risk of surgical site infection (OR 1.74; 95% CI 1.04, 2.91; P = 0.04; I2 = 9%). CONCLUSIONS: Mesh repair for incarcerated and strangulated groin hernias reduces recurrence without an increase in postoperative complications and should be considered in clean cases. However, in the setting of bowel resection, mesh repair might increase the incidence of surgical site infection.


Assuntos
Hérnia Inguinal , Infecção da Ferida Cirúrgica , Humanos , Virilha/cirurgia , Hérnia Inguinal/complicações , Herniorrafia/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Telas Cirúrgicas , Infecção da Ferida Cirúrgica/etiologia
15.
Int J Mol Sci ; 24(18)2023 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-37762254

RESUMO

The Zika Virus (ZIKV) is an emerging arbovirus of great public health concern, particularly in the Americas after its last outbreak in 2015. There are still major challenges regarding disease control, and there is no ZIKV vaccine currently approved for human use. Among many different vaccine platforms currently under study, the recombinant envelope protein from Zika Virus (rEZIKV) constitutes an alternative option for vaccine development and has great potential for monitoring ZIKV infection and antibody response. This study describes a method to obtain a bioactive and functional rEZIKV using an E. coli expression system, with the aid of a 5-L airlift bioreactor and following an automated fast protein liquid chromatography (FPLC) protocol, capable of obtaining high yields of approximately 20 mg of recombinant protein per liter of bacterium cultures. The purified rEZIKV presented preserved antigenicity and immunogenicity. Our results show that the use of an airlift bioreactor for the production of rEZIKV is ideal for establishing protocols and further research on ZIKV vaccines bioprocess, representing a promising system for the production of a ZIKV envelope recombinant protein-based vaccine candidate.


Assuntos
Vacinas Virais , Infecção por Zika virus , Zika virus , Humanos , Zika virus/genética , Proteínas do Envelope Viral/genética , Anticorpos Neutralizantes , Escherichia coli , Anticorpos Antivirais , Vacinas Virais/genética , Vacinas de Subunidades Antigênicas/genética , Proteínas Recombinantes/genética , Reatores Biológicos
16.
Medicina (Kaunas) ; 59(9)2023 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-37763794

RESUMO

Background and Objectives: Robotic surgical systems have rapidly become integrated into colorectal surgery practice in recent years, particularly for rectal resections, where the advantages of robotic platforms over conventional laparoscopy are more pronounced. However, as with any technological advancement, the initial high costs can be a limiting factor, leading to unequal health service access, especially in middle- and lower-income countries. Materials and Method: A narrative review was conducted with the objective of providing an overview of the escalating adoption, current training programmes, and certification process of robotic colorectal surgery in Brazil. Results: Brazil has witnessed a rapid increase in robotic platforms in recent years. Currently, there are 106 robotic systems installed nationwide. However, approximately 60% of the medical facilities which adopted robotic platforms are in the Southeast region, which is both the most populous and economically prosperous in the country. The Brazilian Society of Coloproctology recently established clear rules for the training programme and certification of colorectal surgeons in robotic surgery. The key components of the training encompass theoretical content, virtual robotic simulation, observation, assistance, and supervised procedures in colorectal surgery. Although the training parameters are well established, no colorectal surgery residency programme in Brazil has yet integrated the teaching and training of robotic surgery into its curriculum. Thus far, the training process has been led by private institutions and the industry. Conclusion: Despite the fast spread of robotic platforms across Brazil, several challenges still need to be addressed to democratise training and promote the widespread use of these platforms. It is crucial to tackle these obstacles to achieve greater integration of robotic technology in colorectal surgery throughout the country.


Assuntos
Cirurgia Colorretal , Procedimentos Cirúrgicos do Sistema Digestório , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Brasil
18.
Surg Laparosc Endosc Percutan Tech ; 33(5): 556-564, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37523583

RESUMO

BACKGROUND: Parastomal hernia repairs (PHRs) are often complex and challenging, even for experienced abdominal wall surgeons. Although the ideal therapeutic option in the setting of a parastomal hernia is to restore intestinal continuity, this is often not feasible, and numerous techniques have been described for PHR. Current guidelines recommend using mesh for elective PHR, but there is a scarcity of evidence comparing different PHR techniques. We aimed to report a meta-analysis comparing the outcomes of the "Sugarbaker" and "Keyhole" mesh configuration in PHR. METHODS: A literature search of PubMed, Embase, Scopus, and Cochrane Library databases was performed to identify studies comparing Sugarbaker and Keyhole mesh configuration in PHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 3247 studies were screened, and 27 were fully reviewed. Ten studies and 632 patients were included in the meta-analysis. Three hundred five patients (48.3%) with Keyhole and 327 patients (51.7%) with Sugarbaker mesh configuration. Four hundred thirty-three patients (68.5%) underwent laparoscopic PHR with intraperitoneal onlay mesh. Sugarbaker mesh configuration was associated with lower hernia recurrence compared with Keyhole (odds ratio: 0.39; 95% CI: 0.19-0.83; P = 0.01; I2 = 46%). No differences were seen in overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding. CONCLUSION: PHR with Sugarbaker mesh configuration is associated with decreased hernia recurrence compared with Keyhole and had similar rates of overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding.

19.
BMC Cancer ; 23(1): 546, 2023 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-37316784

RESUMO

BACKGROUND: Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer. METHODS: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival. DISCUSSION: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT05000697; registered on August 11th, 2021.


Assuntos
Deficiência Intelectual , Neoplasias Retais , Humanos , Oxaliplatina , Quimioterapia de Consolidação , Neoplasias Retais/tratamento farmacológico , Quimiorradioterapia
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