ABSTRACT
BACKGROUND: Colon cancer (CC) is a public health concern with increasing incidence in younger populations. Treatment for locally advanced CC (LACC) involves oncological surgery and adjuvant chemotherapy (AC) to reduce recurrence and improve overall survival (OS). Neoadjuvant chemotherapy (NAC) is a novel approach for the treatment of LACC, and research is underway to explore its potential benefit in terms of survival. This trial will assess the efficacy of NAC in LACC. METHODS: This is a multicentre randomised, parallel-group, open label controlled clinical trial. Participants will be selected based on homogenous inclusion criteria and randomly assigned to two treatment groups: NAC, surgery, and AC or surgery followed by AC. The primary aim of this study is to evaluate the 2-year progression-free survival (PFS), with secondary outcomes including 5-year PFS, 2- and 5-year OS, toxicity, radiological and pathological response, morbidity, and mortality. DISCUSSION: The results of this study will determine whether NAC induces a clinical and histological tumour response in patients with CCLA and if this treatment sequence improves survival without increasing morbidity and mortality. REGISTRATION NUMBER: NCT04188158.
Subject(s)
Colonic Neoplasms , Neoadjuvant Therapy , Adult , Aged , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant/methods , Colectomy/methods , Colonic Neoplasms/pathology , Colonic Neoplasms/mortality , Colonic Neoplasms/drug therapy , Colonic Neoplasms/therapy , Colonic Neoplasms/surgery , Neoadjuvant Therapy/methods , Progression-Free Survival , Randomized Controlled Trials as Topic , Treatment Outcome , Multicenter Studies as TopicABSTRACT
Introducción: El objetivo de este estudio es analizar los resultados quirúrgicos a corto plazo de la escisión completa del mesorrecto por vía transanal laparoscópica. Métodos: Análisis en 100 pacientes con cáncer de recto medio e inferior, intervenidos consecutivamente entre noviembre de 2013 y septiembre de 2018. Se describen los datos operatorios, la morbimortalidad y la calidad de la pieza quirúrgica. Se realiza un análisis comparativo entre sexos y la cirugía a uno y a 2 campos simultáneos. Resultados: La mediana de edad fue de 67 años (56-75), siendo el 67% varones. El 50% fueron tumores T3 y el 52% con afectación ganglionar, por RMN. La media de distancia al margen anal fue de 4,9 ± 1,3 cm. El 58% recibió neoadyuvancia. La media de tiempo quirúrgico fue de 262 ± 40,7 min, siendo menor en mujeres (p < 0,001) y en la cirugía simultánea a 2 campos (p = 0,008). La mediana de margen distal fue de 1,5cm (0,5-2,4). Se obtuvo un mesorrecto completo en el 89%, con mejores resultados en la cirugía a 2 campos (p = 0,047). La media de ganglios aislados fue de 15,2 ± 11,6. El 26% de los pacientes tuvieron afectación ganglionar. La mediana de estancia fue de 5,5 días (4-8). Hubo una morbilidad del 36% y un paciente falleció. Conclusiones: La escisión completa del mesorrecto por vía transanal laparoscópica es segura, consiguiendo un adecuado margen circunferencial y distal, con una alta calidad del mesorrecto. Ofrece una morbilidad aceptable para el tipo de intervención quirúrgica, según la literatura actual
Introduction: The aim of this study is to describe and evaluate our clinical short-term surgical results of laparoscopic transanal total mesorectal excision. Methods: Analysis of 100 consecutive patients with mid and lower rectal cancer who underwent transanal total mesorectal excision from November 2013 to September 2018. Main outcomes described are operative data, morbidities, mortality and quality of the specimen. A comparative analysis was done between gender and simultaneous vs. non simultaneous abdominal-perineal surgery. Results: Mean patient age was 67 years (56-75), and 67% were male. On MRI, 50% were stage T3 tumors, and 52% had positive nodes. Mean distance of the tumor from anal verge was 4.9 ± 1.3cm. A total of 58% underwent neoadjuvant treatment. Mean operative time was 262 ± 40.7 min; it was shorter in females (P < .001) and in simultaneous 2-field surgery. Median specimen distal free margin was 1.5 cm (0.5-2.4). A total of 89% of the specimens were with complete mesorectum, with better results when a simultaneous approach was used (P = .047). The mean number of retrieved lymph-nodes was 15.2 ± 11.6, and 26% of patients had positive nodes. Median length of stay was 5.5 days (4-8). Morbidities occurred in 36% of cases, and one patient died. Conclusions: According to our experience, laparoscopic transanal total mesorectal excision is safe and effective with adequate circumferential and distal free margins and high quality of the resected mesorectum specimen. Post-operative morbidity is acceptable, according to the current literature
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Minimally Invasive Surgical Procedures/methods , Rectal Neoplasms/surgery , Rectum/surgery , Transanal Endoscopic Surgery/methods , Anal Canal/surgery , Laparoscopy/methods , Margins of Excision , Minimally Invasive Surgical Procedures/adverse effects , Neoadjuvant Therapy/methods , Neoplasm Staging , Operative Time , Rectal Neoplasms/mortality , Rectum/pathology , Retrospective Studies , Transanal Endoscopic Surgery/adverse effectsABSTRACT
INTRODUCTION: The aim of this study is to describe and evaluate our clinical short-term surgical results of laparoscopic transanal total mesorectal excision. METHODS: Analysis of 100 consecutive patients with mid and lower rectal cancer who underwent transanal total mesorectal excision from November 2013 to September 2018. Main outcomes described are operative data, morbidities, mortality and quality of the specimen. A comparative analysis was done between gender and simultaneous vs. non simultaneous abdominal-perineal surgery. RESULTS: Mean patient age was 67 years (56-75), and 67% were male. On MRI, 50% were stage T3 tumors, and 52% had positive nodes. Mean distance of the tumor from anal verge was 4.9±1.3cm. A total of 58% underwent neoadjuvant treatment. Mean operative time was 262±40.7min; it was shorter in females (P<.001) and in simultaneous 2-field surgery. Median specimen distal free margin was 1.5cm (0.5-2.4). A total of 89% of the specimens were with complete mesorectum, with better results when a simultaneous approach was used (P=.047). The mean number of retrieved lymph-nodes was 15.2±11.6, and 26% of patients had positive nodes. Median length of stay was 5.5 days (4-8). Morbidities occurred in 36% of cases, and one patient died. CONCLUSIONS: According to our experience, laparoscopic transanal total mesorectal excision is safe and effective with adequate circumferential and distal free margins and high quality of the resected mesorectum specimen. Post-operative morbidity is acceptable, according to the current literature.
Subject(s)
Minimally Invasive Surgical Procedures/methods , Rectal Neoplasms/surgery , Rectum/surgery , Transanal Endoscopic Surgery/methods , Aged , Anal Canal/surgery , Female , Humans , Laparoscopy/methods , Length of Stay , Male , Margins of Excision , Middle Aged , Minimally Invasive Surgical Procedures/adverse effects , Neoadjuvant Therapy/methods , Neoplasm Staging , Operative Time , Rectal Neoplasms/mortality , Rectum/pathology , Retrospective Studies , Transanal Endoscopic Surgery/adverse effectsABSTRACT
BACKGROUND: Sex hormones play a role in gastric cancer and colorectal cancer etiology, however, epidemiological evidence is inconsistent. This study examines the influence of menstrual and reproductive factors over the risk of both tumors. METHODS: In this case-control study 128 women with gastric cancer and 1293 controls, as well as 562 female and colorectal cancer cases and 1605 controls were recruited in 9 and 11 Spanish provinces, respectively. Population controls were frequency matched to cases by age and province. Demographic and reproductive data were directly surveyed by trained staff. The association with gastric, colon and rectal cancer was assessed using logistic and multinomial mixed regression models. RESULTS: Our results show an inverse association of age at first birth with gastric cancer risk (five-year trend: OR = 0.69; p-value = 0.006). Ever users of hormonal contraception presented a decreased risk of gastric (OR = 0.42; 95%CI = 0.26-0.69), colon (OR = 0.64; 95%CI = 0.48-0.86) and rectal cancer (OR = 0.61; 95%CI = 0.43-0.88). Postmenopausal women who used hormone replacement therapy showed a decreased risk of colon and rectal tumors. A significant interaction of educational level with parity and months of first child lactation was also observed. CONCLUSION: These findings suggest a protective role of exogenous hormones in gastric and colorectal cancer risk. The role of endogenous hormones remains unclear.
