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BACKGROUND: Sacral neuromodulation might be effective to palliate low anterior resection syndrome after rectal cancer surgery, but robust evidence is not available. OBJECTIVE: To assess the impact of sacral neuromodulation on low anterior resection syndrome symptoms as measured by validated scores and bowel diaries. DESIGN: Randomized, double-blind, 2-phased, controlled, multicenter crossover trial (NCT02517853). SETTINGS: Three tertiary hospitals. PATIENTS: Patients with major low anterior resection syndrome 12 months after transit reconstruction after rectal resection who had failed conservative treatment. INTERVENTIONS: Patients underwent an advanced test phase by stimulation for 3 weeks and received the pulse generator implant if a 50% reduction in low anterior resection syndrome score was achieved. These patients entered the randomized phase in which the generator was left active or inactive for 4 weeks. After a 2-week washout, the sequence was changed. After the crossover, all generators were left activated. MAIN OUTCOME MEASURES: The primary outcome was low anterior resection syndrome score reduction. Secondary outcomes included continence and bowel symptoms. RESULTS: After testing, 35 of 46 patients (78%) had a 50% or greater reduction in low anterior resection syndrome score. During the crossover phase, all patients showed a reduction in scores and improved symptoms, with better performance if the generator was active. At 6- and 12-month follow-up, the mean reduction in low anterior resection syndrome score was -6.2 (95% CI -8.97 to -3.43; p < 0.001) and -6.97 (95% CI -9.74 to -4.2; p < 0.001), with St. Mark's continence score -7.57 (95% CI -9.19 to -5.95, p < 0.001) and -8.29 (95% CI -9.91 to -6.66; p < 0.001). Urgency, bowel emptiness sensation, and clustering episodes decreased in association with quality-of-life improvement at 6- and 12-month follow-up. LIMITATIONS: The decrease in low anterior resection syndrome score with neuromodulation was underestimated because of an unspecific measuring instrument. There was a possible carryover effect in sham stimulation sequence. CONCLUSIONS: Neuromodulation provides symptoms and quality-of-life amelioration, supporting its use in low anterior resection syndrome. See Video Abstract . NEUROMODULACIN SACRA EN PACIENTES CON SNDROME DE RESECCIN ANTERIOR BAJA ENSAYO CLNICO ALEATORIZADO SANLARS: ANTECEDENTES:La neuromodulación sacra podría ser eficaz para paliar el síndrome de resección anterior baja después de la cirugía de cáncer de recto, pero no hay pruebas sólidas disponibles.OBJETIVO:Evaluar el impacto de la neuromodulación sacra en los síntomas del síndrome de resección anterior baja, medido mediante puntuaciones validadas y diarios intestinales.DISEÑO:Ensayo cruzado multicéntrico, controlado, aleatorizado, doble ciego, de dos fases (NCT02517853).LUGARES:Tres hospitales terciarios.PACIENTES:Pacientes con puntuación de resección anterior baja importante, 12 meses después de la reconstrucción del tránsito después de la resección rectal en quienes había fracasado el tratamiento conservador.INTERVENCIONES:Los pacientes se sometieron a una fase de prueba avanzada mediante estimulación durante tres semanas y se les implantó el generador de impulsos si se lograba una reducción del 50% en la puntuación del síndrome de resección anterior baja, ingresando a la fase aleatorizada en la que el generador se dejaba activo o inactivo durante cuatro semanas. Después de observar por 2 semanas, se cambió la secuencia. Después del cruce, todos los generadores quedaron activados.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la reducción de la puntuación del síndrome de resección anterior baja. Los resultados secundarios incluyeron continencia y síntomas intestinales.RESULTADOS:Después de las pruebas, 35 de 46 pacientes (78%) tuvieron una reducción ≥50% en la puntuación del síndrome de resección anterior baja. Durante el cruce, todos los pacientes mostraron una reducción en las puntuaciones y una mejora de los síntomas, con un mejor rendimiento si el generador estaba activo. A los 6 y 12 meses de seguimiento, la reducción media en la puntuación del síndrome de resección anterior baja fue -6,2 (-8,97; -3,43; p < 0,001) y -6,97 (-9,74; -4,2; p < 0,001), con Puntuación de continencia de St. Mark's -7,57 (-9,19; -5,95, p < 0,001) y -8,29 (-9,91; -6,66; p < 0,001). La urgencia, la sensación de vacío intestinal y los episodios de agrupamiento disminuyeron en asociación con una mejora en la calidad de vida a los 6 y 12 meses de seguimiento.LIMITACIONES:La disminución en la puntuación del síndrome de resección anterior baja con neuromodulación se subestimó debido a un instrumento de medición no específico. Posible efecto de arrastre en la secuencia de estimulación simulada.CONCLUSIONES:La neuromodulación mejora los síntomas y la calidad de vida, lo que respalda su uso en el síndrome de resección anterior baja. (Traducción-Dr. Mauricio Santamaria ).
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Terapia por Estimulación Eléctrica , Neoplasias del Recto , Humanos , Síndrome de Resección Anterior Baja , Complicaciones Posoperatorias/terapia , Complicaciones Posoperatorias/diagnóstico , Neoplasias del Recto/cirugía , Estudios Retrospectivos , Sacro , Método Doble CiegoRESUMEN
OBJECTIVE: To assess the effect of high inferior mesenteric artery tie on defecatory, urinary, and sexual function after surgery for sigmoid colon cancer. Performing a sigmoidectomy poses a notable risk of causing injury to the preaortic sympathetic nerves during the high ligation of the inferior mesenteric artery, as well as to the superior hypogastric plexus during dissection at the level of the sacral promontory. Postoperative defecatory and genitourinary dysfunction after sigmoid colon resection are often underestimated and underreported. METHODS: This study is a secondary research of a multicenter, single-blind, randomized clinical trial. The trial involved patients with sigmoid cancer who underwent either extended complete mesocolic excision (e-CME) or standard CME (s-CME). Patients completed questionnaires to assess defecatory, urinary, and sexual function before, 1 month after surgery, and 1 year after surgery. Multivariate analysis was conducted to identify factors associated with functional dysfunction. RESULTS: Seventy-nine patients completed functional assessments before and 1 year after surgery. One year after sigmoidectomy with a high tie of the inferior mesenteric artery, 15.2% of patients had minor low anterior resection syndrome (LARS) and 12.7% had major LARS; 22.2% of males and 29.4% of females had urinary dysfunction; and 43.8% of males and 27.3% of females had sexual dysfunction. After multivariate analysis, no significant associations were found between clinical and surgical factors and gastrointestinal or urinary dysfunction after 1 year of surgery. Age was identified as the only factor linked to sexual dysfunction in both sexes (women, ß = - 0.54, p = 0.002; men ß = - 0.38, p = 0.010). Regarding recovery outcomes, diabetes mellitus was identified as a contributing factor to suboptimal gastrointestinal recovery (p = 0.033) and urinary recovery in women (p = 0.039). Furthermore, the treatment arm was found to be significantly associated with the recovery of erectile function after 1 year of surgery (p = 0.046). CONCLUSIONS: A high tie of the inferior mesenteric artery during sigmoidectomy is associated with a high incidence of defecatory and genitourinary dysfunction. Age was identified as a significant factor associated with sexual dysfunction 1 year after sigmoid colon resection in both sexes. TRIAL REGISTRATION: Clinical trials NCT03083951 HIGHLIGHTS: ⢠One year after high-tie sigmoidectomy, 27.9% of patients had LARS; 22.2% of the men and 29.4% of the women had urinary dysfunction; and 43.8% of the men and 27.3% of the women had sexual dysfunction. ⢠e-CME is associated with a high rate of urinary dysfunction in men 1 year after surgery. However, after multivariate analysis, no association was found between e-CME and urinary dysfunction in men. ⢠Age was correlated with the recovery of sexual function in both sexes 1 year after surgery. Furthermore, diabetes mellitus was identified as the factor associated with poorer recovery of urinary function in females.
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Laparoscopía , Mesocolon , Neoplasias del Recto , Masculino , Humanos , Femenino , Colon Sigmoide/cirugía , Mesocolon/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Neoplasias del Recto/cirugía , Método Simple Ciego , Colectomía/efectos adversosRESUMEN
OBJECTIVE: The aim of this study was to evaluate whether extended complete mesocolic excision (e-CME) for sigmoid colon cancer improves oncological outcomes without compromising morbidity or functional results. BACKGROUND: In surgery for cancer of the sigmoid colon and upper rectum, s-CME removes the lymphofatty tissue surrounding the inferior mesenteric artery (IMA), but not the lymphofatty tissue surrounding the portion of the inferior mesenteric vein that does not run parallel to the IMA. Evidence about the safety and efficacy of extending CME to include this tissue is lacking. METHODS: This single-blind study randomized sigmoid cancer patients at 4 centers to undergo e-CME or s-CME. The primary outcome was the total number of lymph nodes harvested. Secondary outcomes included disease-free and overall survival at 2âyears, morbidity, and bowel and genitourinary function. Clinicaltrials.gov: NCT03107650. RESULTS: We analyzed 93 patients (46 e-CME and 47 s-CME). Perioperative outcomes were similar between groups. No differences between groups were found in the total number of lymph nodes harvested [21 (interquartile range, IQR, 14-29) in e-CME vs 20 (IQR, 15-27) in s-CME, P = 0.873], morbidity (P = 0.829), disease-free survival (P = 0.926), or overall survival (P = 0.564). The extended specimen yielded a median of 1 lymph node (range, 0-6), none of which were positive.Bowel function recovery was similar between arms at all timepoints. Males undergoing e-CME had worse recovery of urinary function (P = 0.026). CONCLUSION: Extending lymphadenectomy to include the IMV territory did not increase the number of lymph nodes or improve local recurrence or survival rates.
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Colectomía/métodos , Mesocolon/cirugía , Neoplasias del Colon Sigmoide/cirugía , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Método Simple Ciego , Resultado del TratamientoRESUMEN
BACKGROUND: Efforts to determine whether metformin can increase the effectiveness of neoadjuvant chemoradiotherapy in rectal cancer have increased in recent years. However, retrospective studies have yielded inconclusive results. OBJECTIVES: The aim of this study was to compare oncological outcomes and survival after neoadjuvant chemoradiotherapy in patients with rectal cancer taking metformin versus in those not taking metformin. METHODS: This study analyzed 423 consecutive patients with locally advanced rectal cancer who underwent neoadjuvant chemoradiotherapy and curative surgery between January 2010 and May 2020; of these, 59 were taking metformin and 364 were not taking metformin. RESULTS: Patients taking metformin had a lower proportion of tumor regression (6.8% versus 22.0%, P = 0.012) as well as a lower proportion of patients achieving a pathological complete response (6.8% versus 20.6%, P = 0.011). In the multivariate analysis, independent predictors of pathologic complete response were not taking metformin (OR: 5.26, 95% CI: 1.12-24.85, P= 0.035) and cT2 stage (OR: 3.49, 95% CI: 1.10-11.07, P= 0.034); the interval was also an independent predictor of tumor regression (OR: 1.78, 95% CI: 1.06-2.96, P= 0.028). No differences were observed in survival between groups. CONCLUSION: Metformin was not associated with better tumor responses or survival after neoadjuvant treatment.
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Metformina , Neoplasias del Recto , Quimioradioterapia , Humanos , Metformina/uso terapéutico , Terapia Neoadyuvante/métodos , Estadificación de Neoplasias , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: Laparoscopic surgery for rectal cancer is technically complex. This study aimed to identify risk factors for suboptimal laparoscopic surgery (involved margins, incomplete mesorectal excision, and/or conversion to open surgery) in patients with rectal cancer. METHODS: We included patients undergoing laparoscopic anterior resection for rectal cancer between June 2009 and June 2018. We defined the outcome variable suboptimal laparoscopic surgery as conversion to open surgery or inadequate histopathological specimens (margins < 1 mm or involved and/or poor-quality mesorectal excision). To identify independent predictors of suboptimal laparoscopic surgery, we analyzed 15 prospectively recorded demographic, clinical, and anthropometric variables obtained from our rectal cancer unit's database. Subanalyses examined the same variables with respect to conversion and to inadequate histopathological specimens. RESULTS: Of the 323 patients included, 91 (28.2%) had suboptimal laparoscopic surgery. In the multivariate analysis, the independent factors associated with all suboptimal laparoscopic surgery were tumor location ≤ 5 cm from the anal verge (OR = 2.95, 0.95% CI 1.32-6.60; p = 0.008) and the intertuberous distance (OR = 0.79, 0.95% CI 0.65-0.96; p = 0.019). In the subanalyses, the promontorium-retropubic axis was an independent predictor of conversion (OR 0.70, 0.95% CI 0.51-0.96; p = 0.026), and tumor location ≤ 5 cm from the anal verge (OR 3.71, 0.95% 1.51-9.15; p = 0.004) was an independent predictor of inadequate histopathological specimens. CONCLUSIONS: Predictive factors for suboptimal laparoscopic anterior resection for rectal cancer were tumor location and the intertuberous distance. These results could help surgeons decide whether to use other surgical approaches in complex cases. TRIAL REGISTRATION: The study was registered at Clinicaltrials.org (No. NCT03107650).
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Laparoscopía , Neoplasias del Recto , Conversión a Cirugía Abierta , Humanos , Neoplasias del Recto/cirugía , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The inferior mesenteric artery approach with a selective lateral splenic flexure mobilization is the most widely used initial step in laparoscopic rectal and left colon surgery. Surgery started through the inferior mesenteric vein (IMV) with systematic medial mobilization (MM) has some theoretical advantages that have never been analyzed in a clinical trial. The aim of this study was to compare the two techniques with regards to surgical technique variables (conversion, surgical time, bleeding, morbidity, and mortality) and pathological outcomes. METHODS: A single-blinded, randomized, controlled trial of patients operated electively by laparoscopic with curative intention for rectal or sigmoid cancer was performed at a single, specialized colorectal surgery department from April 2016 to October 2017. RESULTS: 49 patients were included in each group. There were no statistical differences in patient demographics between the two approaches. Pathological outcomes did not differ between the two groups. Intra-operative characteristics showed a higher conversion rate in patients in which the inferior mesenteric artery was dissected first (p = 0.031). The artery approach also increased intra-operative bleeding (p = 0.049), but there were no differences regarding operative time. On multivariate analysis, the artery approach was associated with a higher risk of conversion (OR 8.68; p = 0.050). Post-operatory complications did not differ between artery and vein dissection. CONCLUSIONS: In our study, the initial approach by the IMV with a systematic MM of the splenic flexure has allowed us to reduce the conversion rate without increasing complications or the surgical time. No differences were observed in the pathological results. Both approaches seem to be safe and effective and well-trained laparoscopic surgeons should have the two techniques available to them for use as needed.
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Laparoscopía/métodos , Arteria Mesentérica Inferior/cirugía , Venas Mesentéricas/cirugía , Neoplasias del Recto/cirugía , Neoplasias del Colon Sigmoide/cirugía , Pérdida de Sangre Quirúrgica , Disección/efectos adversos , Disección/métodos , Femenino , Humanos , Laparoscopía/efectos adversos , Masculino , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias , Método Simple CiegoRESUMEN
Male urethral injury during rectal cancer surgery is rare but significant. Scant information is available about the distances between the rectourethral space and neighboring structures. The aim of this study is to describe the anatomical relations of the male urethra. This three-pronged study included cadaveric dissection, retrospective MRI analysis, and clinical cases. Measurements included the R-Mu distance (shortest distance between the rectum and the membranous urethra), R-Am distance (distance from the anterior rectal wall to anal margin nearest to the membranous urethra), and the anal canal-rectum axis angle. The clinical study analyzed the incidence of urethral injury and associated factors among 244 consecutive men from January 2016 to January 2023. The overall incidence of urethral injury in our series was low (0.73%), but in men with tumors < 10 cm from the anal margin, it was 4% in abdominoperineal resection and 3.2% in TaTME. On preoperative MRI, the median R-Mu distance was 1 cm (IQR, range, 0.2-2.3), the median R-Am distance was 4.3 cm (range, 2-7.3), and the median anorectal angle was 128° (range, 87-160). In the cadaveric study (nine adult male pelvises), the mean R-Mu distance was 1.18 cm (range 0.8-2), and the mean R-Am distance was 2.64 cm (range 2.1-3). Avoiding urethral injury is crucial. The critical point for injury lies 2-7.3 cm from the anal margin, with a 0.2-2.3 cm distance between the rectum and the membranous urethra. Collaborating with anatomists and radiologists improves surgeons' anatomy knowledge.
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New techniques are being developed to improve the results of laparoscopic surgery for rectal cancer. This paper analyzes the learning curves for transanal total mesorectal excision (taTME) and robot-assisted surgery in our colorectal surgery department. We analyzed retrospectively data from patients undergoing curative and elective surgery for rectal cancer ≤12 cm from the anal verge. We excluded extended surgeries. We used cumulative sum (CUSUM) curve analysis to identify inflection points. Between 2015 and 2021, 588 patients underwent surgery for rectal cancer at our center: 67 taTME and 79 robot-assisted surgeries. To overcome the operative time learning curve, 14 cases were needed for taTME and 53 for robot-assisted surgery. The morbidity rate started to decrease after the 17th case in taTME and after the 49th case in robot-assisted surgery, but it is much less abrupt in robot-assisted group. During the initial learning phase, the rate of anastomotic leakage was higher in taTME (35.7% vs. 5.7%). Two Urological lesions occurred in taTME but not in robot-assisted surgery. The conversion rate was higher in robot-assisted surgery (1.5% vs. 10.1%). Incorporating new techniques is complex and entails a transition period. In our experience, taTME involved a higher rate of serious complications than robot-assisted surgery during initial learning period but required a shorter learning curve.
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INTRODUCTION: Significant celiac trunk or artery stenosis (CAS) is normally asymptomatic. However, when the arteries of the pancreatoduodenal arcade are occluded, it could trigger a visceral ischaemia. The objective of this study is to determine whether preoperative CAS is a risk factor for developing complications in patients subjected to duodenopancreatectomy (DPC). MATERIAL AND METHODS: We have retrospectively analysed 58 consecutive patients subjected to DPC. We have associated significant CAS with post-surgical outcome. In all cases a 16-channel multidetector computed tomography (MDCT) in three hepatic phases was performed. We have reviewed the pre-surgical MDCT focusing on the morphology of the celiac artery (CA), particularly in the presence or absence of significant stenosis (>50%). RESULTS: We found CAS >50% in 13 patients (22%). The overall mortality was 5% (3 patients). Serious complications developed in 16 (28%) patients, 8 (62%) of whom belonged to the group with significant CAS (P=.004). Ten patients (17%) had a pancreatic fistula, 5 (38%) vs. 5 (11%) (P=.036); Fourteen patients (24%) needed new surgery, 7 (54%) vs. 7 (16%) (P=.009); Seven patients (12%) had a haemoperitoneum, 4 (31%) vs. 3 (7%) (P=.038), in the group with and without CAS, respectively. CONCLUSIONS: Significant radiological CAS is a risk factor of serious complications after DPC. The study of the calibre of the superior mesenteric artery (SMA) with MDCT should be routine before a DPC. The correction of a significant CAS should be evaluated preoperatively.
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Arteriopatías Oclusivas/complicaciones , Arteria Celíaca , Pancreaticoduodenectomía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Low anterior resection syndrome affects 60%-90% of patients with anastomoses after colorectal resection. Consensus regarding the best anastomosis is lacking. OBJECTIVE: To compare outcomes after end-to-end versus side-to-end anastomoses. DESIGN: Randomized clinical trial. SETTINGS: University hospital (April 2016-October 2017). PATIENTS: Patients aged ≥18 years with rectal or sigmoid adenocarcinoma. INTERVENTIONS: Patients were randomized to undergo mechanical end-to-end or side-to-end (n = 33) anastomosis after laparoscopic resection. MAIN OUTCOME MEASURES: Primary outcome was to assess intestinal function (COREFO and LARS questionnaires) 12 months after surgery or ileostomy closure. Secondary outcomes were postoperative complications and intestinal function and quality of life (SF-36® questionnaire) at different time points after surgery or ileostomy closure. RESULTS: No significant differences in intestinal function were observed between the two groups 12 months after surgery. Subanalysis of low-mid rectum tumors with end-to-end anastomosis yielded better function at 12 months. Postoperative complications did not differ between the two groups (p = 0.070), but reinterventions were more common in the side-to-end group (p = 0.040). Multivariate analysis found neoadjuvant treatment was independently associated with intestinal dysfunction at 12 months (ß = 0.41, p = 0.033, COREFO; ß = 0.41, p = 0.024, LARS). CONCLUSIONS: End-to-end anastomosis yielded low rates of severe complications and reintervention, as well as better intestinal function at 12 months in the subgroup with tumors in the low-mid rectum. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02746224.
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Adenocarcinoma/cirugía , Anastomosis Quirúrgica/métodos , Neoplasias del Recto/cirugía , Recto/cirugía , Neoplasias del Colon Sigmoide/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Anastomosis Quirúrgica/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Método Simple CiegoRESUMEN
OBJECTIVES: To study the performance of the intraoperative ecography in the diagnosis of new liver metastases in the era of computerized tomography (CT) with multidetectors and its impact on the surgical operation. PATIENTS AND METHOD: Between February 2005 and April 2006 patients with resectable liver metastases where studied prospectively in a multidisciplinary meeting (surgeons, radiologist, oncologist). The preoperative CT findings were compared with the intraoperative findings and ultrasound study and the results of the surgical operation. RESULTS: Forty-five candidates for curative surgery had a total of 171 hepatic lesions. CT correctly detected 115 lesions with a sensitivity of 67%, and a positive predictive value of 97%, with a false negative rate of 33% and false positive rate of 2%. In 5 patients intraoperative findings were the cause of changing the surgical procedure, three patients were unresectable (rate of resectability of 93%) and two patients needed a larger hepatic resection. CONCLUSIONS: CT with multidetectors and multidisciplinary meetings are the most important factors in the decision making of surgery of liver metastases with a high resectability rate. Intraoperative ecography is useful for the detection of 10% more liver metastases, but rarely involves a change in the surgical procedure.