Observational cross-sectional study of compliance with the fast track protocol in elective surgery for colon cancer in Spain.

PURPOSE: The purpose of this study was to establish the degree of compliance with the fast track (enhanced recovery) protocol in habitual clinical practice and to determine which measures are fundamental for achieving the results obtained by applying the entire protocol. METHODS: Observational, cross-sectional, multicenter trial was conducted. Participating hospitals prospectively recorded data from at least ten consecutive patients undergoing surgery for colon cancer who were applied some or all of the items comprising the enhanced recovery protocol. The data were analyzed both globally and dividing the sample into the two groups of patients. RESULTS: Data on 363 patients from 25 hospitals were recorded, one hundred seventy-three in the "non-fast track" group and 190 in the "fast track" group. The non-fast track group complied with a mean of 5.4 (±1.8) items and the fast track group with a mean of 8.4 (±1.8) items. The mean functional hospital stay was 7.3 (±5.1) days in the non-fast track group and 6.2 (±5.1) days in the fast track group (p < 0.05). Morbidity was 31.1 % in the fast track group and 24.3 % in the non-fast track group, though the differences were not statistically significant. The only prognostic factors that have an impact on improving the results are measures against hypothermia and mobilization before 24 h. CONCLUSION: Compliance with the enhanced recovery protocol is not exhaustive in habitual clinical practice. However, greater compliance was associated with shorter hospital stay without any increase in morbidity. The only items clearly associated with reduced functional hospital stay were measures against hypothermia and mobilization before 24 h.

Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia.

BACKGROUND: The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate. OBJECTIVE: To reduce the incidence of PH by implanting a lightweight mesh in the sublay position. MATERIAL AND METHODS: Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery. RESULTS: : The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08). CONCLUSIONS: Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.

[Site of local surgery in adenocarcinoma of the rectum T2N0M0]. / Lugar de la cirugía local en el adenocarcinoma de recto T(2)N(0)M(0).

INTRODUCTION: The local exeresis adenocarcinoma of the rectum T(2)N(0)M(0) (ADC-T2), using transanal endoscopic microsurgery (TEM), has the benefit of achieving lower morbidity with a better quality of life. However, local occurrence of the local exeresis is greater than 20%, which is unacceptable these days. PATIENTS AND METHODS: Prospective, observational follow up study. The tumours committee agreed that those ADC-T2 patients could have the following treatments: total mesorectal excision (TME), simple TEM, TEM with postoperative chemo- and radiotherapy (Ct-Rt), preoperative Ct-Rt with subsequent TEM and radical surgical rescue (TME) within at least 4 weeks. RESULTS: Of the 146 patients operated on using TEM, 75 had adenocarcinomas, 59 adenomas, 6 scarring wounds, 5 carcinoids and 1 GIST. Of the adenocarcinomas 22 were ADC-T2. Follow up: median of 16 months (range, 3-32 months). The overall local recurrence was 18% (4/22). According to the treatment strategy the local occurrence was: TEM as the only procedure, 20% (2/10). Radical surgical rescue was performed on 3 patients after TEM, with no local or systemic recurrences. TEM with Qt-Rt after surgery was performed on 6 patients, with a local recurrence of 33% (2/6). Ct-Rt and subsequent TEM in 3 patients, with no local or systemic recurrences. CONCLUSIONS: Treatment of ADC-T2 using simple TEM is not effective. The combination of Ct-Rt after TEM, does not improve the results of TME. It is possible to rescue those patients without changing the overall survival. Preoperative Ct-Rt and TEM appears to be the approach that obtains a clinical and histological response, although a response is needed by clinical trials.

[A prospective, randomised, controlled study on the need to mechanically prepare the colon in scheduled colorectal surgery]. / Estudio prospectivo controlado y aleatorizado sobre la necesidad de la preparación mecánica de colon en la cirugía programada colorrectal.

INTRODUCTION: Mechanical preparation of the colon (MPC) in colorectal surgery has been a dogma that has been questioned over the last few years. The objective of this study is to demonstrate that morbidity in scheduled colorectal surgery is the same or lower without MPC. MATERIAL AND METHOD: Patients subjected to scheduled left colon and rectal surgery with primary anastomosis randomised into two groups. The "Preparation" group (MPC) received MPC and the "non-preparation" group (No-MPC) had only cleaning enemas. The variables collected were: demographic, oncological, nutritional, risk prediction models and morbidity-mortality. RESULTS: Of the 193 patients included: 69 received MPC and 71 did not; 89 patients with colocolic anastomosis (MPC, 38; no MPC, 51) and 50 colorectal (MPC, 31; no MPC, 19). Statistically significant differences were seen in the overall analysis in favour of "no preparation" as regards morbidity (43.55 % with MPC and 27% with No MPC) and nosocomial infection (27.5% and 11.4%). There was 11.6% wound infections in the MPC compared to 5.7% in the no MPC, which was not statistically significant. The only mortalities were in the MPC group 2/69 (2.9% of patients). As regards the location of the anastomosis, in the colocolics the differences were more pronounced, with statistically significant differences in the morbidity, anastomosis dehiscence, and nosocomial infection variables. The effect of no MPC was not so evident in colorectal anastomosis. CONCLUSIONS: Our results suggest that there is no benefit in MPC before surgery in colocolic anastomosis. No-MPC is not associated with a higher morbidity in wound infection or anastomotic dehiscence. In colorectal anastomosis the differences are not so evident, therefore a much bigger series needs to be studied.

Lugar de la cirugía local en el adenocarcinoma de recto T2N0M0 / Site of local surgery in adenocarcinoma of the rectum T2N0M0

Introducción: la exéresis local del adenocarcinoma de recto T2N0M0 (ADC-T2), mediante microcirugía endoscópica transanal (TEM), se beneficia en conseguir una menor morbilidad con mejor calidad de vida. Sin embargo, la recidiva local de la exéresis local es superior al 20%, inaceptable en estos momentos. Pacientes y método: estudio observacional de seguimiento prospectivo. Los pacientes ADC-T2 son consensuados en el comité de tumores a las actuaciones terapéuticas: escisión total del mesorrecto (ETM), TEM simple, TEM con quimiorradioterapia (Qt-Rt) postoperatoria, Qt-Rt preoperatoria con posterior TEM y rescate a cirugía radical (ETM) en menos de 4 semanas. Resultados: se ha intervenido a 146 pacientes mediante TEM; 75 adenocarcinomas, 59 adenomas, 6 lesiones cicatriciales, 5 carcinoides y 1 GIST. De los adenocarcinomas, 22 fueron ADC-T2. Seguimiento: mediana, 16 (intervalo, 3-32) meses. La recidiva local total ha sido del 18% (4/22). Según la estrategia terapéutica la recidiva local fue: TEM como único procedimiento en el 20% (2/10). Se realizó en 3 pacientes rescate a cirugía radical tras TEM, sin recidiva local ni sistémica. TEM con Qt-Rt posterior a la cirugía se realizó en 6, con una recidiva local del 33% (2/6). Se practicó Qt-Rt y posteriormente TEM en 3 pacientes, sin recidiva local ni sistémica. Conclusiones: el tratamiento del ADC-T2 mediante TEM simple no es razonable. La asociación de Qt-Rt tras TEM, no consigue mejorar los resultados a la ETM. Es factible rescatar a los pacientes sin que altere la supervivencia total. La Qt-Rt preoperatoria y TEM parece ser la línea cuando se consiga una respuesta histológica y clínica, aunque es necesaria la respuesta por parte de ensayos clínicos (AU)

Introduction: The local exeresis adenocarcinoma of the rectum T2N0M0 (ADC-T2), using transanal endoscopic microsurgery (TEM), has the benefit of achieving lower morbidity with a better quality of life. However, local occurrence of the local exeresis is greater than 20%, which is unacceptable these days. Patients and methods: Prospective, observational follow up study. The tumours committee agreed that those ADC-T2 patients could have the following treatments: total mesorectal excision (TME), simple TEM, TEM with postoperative chemo- and radiotherapy (Ct-Rt), preoperative Ct-Rt with subsequent TEM and radical surgical rescue (TME) within at least 4 weeks. Results: Of the 146 patients operated on using TEM, 75 had adenocarcinomas, 59 adenomas, 6 scarring wounds, 5 carcinoids and 1 GIST. Of the adenocarcinomas 22 were ADC-T2. Follow up: median of 16 months (range, 3¿32 months). The overall local recurrence was 18% (4/22). According to the treatment strategy the local occurrence was: TEM as the only procedure, 20% (2/10). Radical surgical rescue was performed on 3 patients after TEM, with no local or systemic recurrences. TEM with Qt-Rt after surgery was performed on 6 patients, with a local recurrence of 33% (2/6). Ct-Rt and subsequent TEM in 3 patients, with no local or systemic recurrences. Conclusions: Treatment of ADC-T2 using simple TEM is not effective. The combination of Ct-Rt after TEM, does not improve the results of TME. It is possible to rescue those patients without changing the overall survival. Preoperative Ct-Rt and TEM appears to be the approach that obtains a clinical and histological response, although a response is needed by clinical trials (AU)

Estudio prospectivo controlado y aleatorizado sobrela necesidad de la preparación mecánica de colonen la cirugía programada colorrectal / A prospective, randomised, controlled study on the need to mechanically prepare the colon in scheduled colorectal surgery

Introducción: la preparación mecánica de colon (PMC) en la cirugía colorrectal es un dogma que se ha cuestionado en los últimos años. El objetivo de este estudio es demostrar que la morbilidad en cirugía programada colorrectal es igual o menor sin la PMC. Material y método: pacientes sometidos a cirugía programada de colon izquierdo y recto con anastomosis primaria fueron aleatorizados en dos grupos. Al grupo PMC se le practicó la preparación y al grupo sin PMC, sólo enemas de limpieza. Se recogieron variables demográficas, oncológicas, nutricionales y quirúrgicas, modelos de predicción de riesgo y morbimortalidad. Resultados: se incluyó a 193 pacientes, 69 con PMC y 71 sin ella; 89 pacientes con anastomosis colocólica (PMC, 38; sin PMC, 51) y 50 con anastomosis colorrectal (PMC, 31; sin PMC,19). En el análisis general, se apreciaron diferencias estadísticamente significativas a favor de no preparar en cuanto a la morbilidad (el 43,5% en el PMC y el 27% en los sin PMC) e infección nosocomial (el 27,5 y el 11,4%). En la infección de herida, sin diferencias estadísticamente significativas, se obtuvo el 11,6% en el PMC, frente al 5,7% en el sin PMC. Las únicas muertes fueron 2/69 (2,9%) pacientes en el grupo PMC. Según localización de anastomosis, en las colocólicas las diferencias fueron más acusadas y estadísticamente significativas en las variables morbilidad, dehiscencia de anastomosis e infección nosocomial. en las anastomosis colorrectales no fue tan evidente el efecto de no preparar. Conclusiones: nuestros resultados indican que no existe un beneficio de la PMC en la cirugía ante anastomosis colocólicas. No preparar no tiene relación con más morbilidad en infección de herida ni dehiscencia anastomótica. En anastomosis colorrectales, las diferencias no tan evidentes hacen necesarias series más amplias (AU)

Introduction: Mechanical preparation of the colon (MPC) in colorectal surgery has been a dogma that has been questioned over the last few years. The objective of this study is to demonstrate that morbidity in scheduled colorectal surgery is the same or lower without MPC. Material and method: Patients subjected to scheduled left colon and rectal surgery with primary anastomosis randomised into two groups. The “Preparation” group (MPC) received MPC and the “non-preparation” group (No-MPC) had only cleaning enemas. The variables collected were: demographic, oncological, nutritional, risk prediction models and morbidity-mortality. Results: Of the 193 patients included: 69 received MPC and 71 did not; 89 patients with (..) (AU)

[Anorectal disorders in the immediate and late postoperative period after transanal endoscopic microsurgery]. / Valoración de las alteraciones de la función anorrectal en el postoperatorio inmediato y tardío tras la microcirugía transanal endoscópica.

INTRODUCTION AND OBJECTIVE: Transanal endoscopic microsurgery (TEM) is a new technique for local excision of benign and incipient malignant rectal lesions. This technique offers technological advantages over other procedures and is associated with lower morbidity and mortality. TEM involves prolonged dilatation of the anal sphincter with a large-diameter (4 cm) operating rectoscope. The aim of the present study was to assess the effects of TEM on anorectal function. MATERIAL AND METHODS: All patients undergoing TEM were included. Continence was scored by a numeric scale and anorectal manometry before surgery and 3 weeks and 4 months after surgery. Variations in anal resting pressure, maximal anal resting pressure and the anal continence questionnaire were evaluated. RESULTS: Sixty-eight patients underwent TEM between June 2004 and August 2006. Mean anal resting pressure (ARP) and maximal anal resting pressure (MARP) were significantly reduced at 3 weeks after surgery (ARP/MARP before surgery: 38.89/126.28; 3 weeks after surgery: 26.61/104.75). No significant change was found in the mean continence score. No association was found between variation in pressures and operating time. CONCLUSION: TEM produced statistically significant alterations in anorectal physiology studies which returned to normal at 4 months. The technique did not affect continence scores in the immediate or late postoperative period and consequently can be considered a safe procedure that does not produce significant alterations in anorectal function.

Valoración de las alteraciones de la función anorrectal en el postoperatorio inmediato y tardío tras la microcirugía transanal endoscópica / Anorectal disorders in the immediate and late postoperative period after transanal endoscopic microsurgery

Introducción y objetivo. La microcirugía transanal endoscópica (TEM) es una técnica innovadora que permite la escisión local de lesiones rectales, benignas y malignas en fase inicial con mayores ventajas técnicas y menor morbimortalidad que mediante las técnicas habituales. Precisa de un utillaje específico; destaca un rectoscopio de 4 cm de diámetro que provoca una dilatación anal mantenida. El objetivo de nuestro estudio es comprobar los efectos de la TEM en la funcionalidad anorrectal. Material y métodos. Se incluyó a todos los pacientes intervenidos por vía TEM a los que se les realizó una manometría y un cuestionario de continencia anal preoperatoria y a las 3 semanas y 4 meses postoperatorios. Se valoraron las variaciones en la presión basal (PB) y en la presión de contracción voluntaria (PCV); también las variaciones en el cuestionario de continencia anal. Resultados. Se intervino a 68 pacientes entre junio de 2004 y agosto de 2006. Al analizar la PB y la PCV preoperatorias (38,89; 126,28) se observó una disminución estadísticamente significativa de ambas presiones a las 3 semanas (26,61; 104,75) que retorna a valores basales a los 4 meses (33,81; 118,9). No hubo variaciones en la prueba de continencia anal ni relación entre la variación de las presiones y el tiempo quirúrgico. Conclusión. La TEM produce una alteración manométrica estadísticamente significativa que se normaliza a los 4 meses y que no se traduce en ninguna alteración clínica en el postoperatorio inmediato ni en el tardío y, por tanto, es una técnica segura que no produce alteraciones en la funcionalidad anorrectal (AU)

Introduction and objective. Transanal endoscopic microsurgery (TEM) is a new technique for local excision of benign and incipient malignant rectal lesions. This technique offers technological advantages over other procedures and is associated with lower morbidity and mortality. TEM involves prolonged dilatation of the anal sphincter with a large-diameter (4 cm) operating rectoscope. The aim of the present study was to assess the effects of TEM on anorectal function. Material y methods. All patients undergoing TEM were included. Continence was scored by a numeric scale and anorectal manometry before surgery and 3 weeks and 4 months after surgery. Variations in anal resting pressure, maximal anal resting pressure and the anal continence questionnaire were evaluated. Results. Sixty-eight patients underwent TEM between June 2004 and August 2006. Mean anal resting pressure (ARP) and maximal anal resting pressure (MARP) were significantly reduced at 3 weeks after surgery (ARP/MARP before surgery: 38.89/126.28; 3 weeks after surgery: 26.61/104.75). No significant change was found in the mean continence score. No association was found between variation in pressures and operating time. Conclusion. TEM produced statistically significant alterations in anorectal physiology studies which returned to normal at 4 months. The technique did not affect continence scores in the immediate or late postoperative period and consequently can be considered a safe procedure that does not produce significant alterations in anorectal function (AU)

[Transanal endoscopic microsurgery (TEM). Current situation and future expectations]. / Microcirugía endoscópica transanal (TEM). Situación actual y expectativas de futuro.

Transanal endoscopic microsurgery (TEM) uses specific equipment that allows resection of large rectal adenomas and incipient malignancies in the rectal ampulla. TEM aims to provide an alternative to conventional abdominal surgery (low anterior resection or abdominoperineal amputations), which carries not inconsiderable morbidity and mortality. Application of the technique of endoanal excision is limited by the height and extension of the lesions. In this review, the authors present their own experience with this technique and that described in the literature. The protocol for selecting candidates for TEM, their preoperative preparation, equipment, characteristics of the surgical technique, postoperative complications, and follow-up are described. The collaboration of a multidisciplinary team is essential when developing this technique. TEM-associated morbidity is low and mortality is practically nil. TEM is the technique of choice in large rectal adenomas and malignant rectal tumors in stages pT1 localized in the rectal ampulla. The frequency of recurrence is similar to that in abdominal surgery. The technique does not cause complications of urinary or sexual dysfunction and fecal incontinence is minimal. In more advances stages of rectal cancer, the results of better patient selection and future studies on the possible application of neoadjuvant therapy associated with TEM are required.

Microcirugía endoscópica transanal (TEM). Situación actual y expectativas de futuro / Transanal endoscopic microsurgery (TEM). Current situation and future expectations

La microcirugía endoscópica transanal (TEM) es un procedimiento por el que, mediante instrumental específico, es posible la exéresis de grandes adenomas de recto y cánceres incipientes en la ampolla rectal. La TEM intenta dar respuesta a la alternativa de la cirugía convencional abdominal (resección anterior baja o amputaciones abdominoperineales) a la que se asocia una no desdeñable morbimortalidad. La aplicación de la técnica de exéresis endoanal está limitada por la altura y la extensión de las lesiones. En esta revisión se intenta exponer la experiencia de los autores respecto a la descrita en la literatura. Se describe el protocolo de selección de los pacientes candidatos a TEM, su preparación preoperatoria, el instrumental, las características de la técnica quirúrgica, las complicaciones postoperatorias y el seguimiento de los pacientes. Para todo ello, es objetivo primordial desarrollar esta técnica en el medio colaborativo de un equipo multidisciplinario. La morbilidad relacionada con la TEM es escasa y la mortalidad, prácticamente nula. Es la técnica de elección en grandes adenomas rectales y cánceres de recto con estadios pT1 localizados en toda la ampolla rectal. Los resultados de recidiva son similares a los de la cirugía abdominal y no tiene complicaciones de disfunción urinaria o sexual y las de incontinencia fecal son mínimas. En estadios más avanzados de cáncer de recto, es necesario esperar resultados con una mejor selección de pacientes y nuevos datos con la posible aplicación de la neoadyuvancia asociada a la TEM (AU)

Transanal endoscopic microsurgery (TEM) uses specific equipment that allows resection of large rectal adenomas and incipient malignancies in the rectal ampulla. TEM aims to provide an alternative to conventional abdominal surgery (low anterior resection or abdominoperineal amputations), which carries not inconsiderable morbidity and mortality. Application of the technique of endoanal excision is limited by the height and extension of the lesions. In this review, the authors present their own experience with this technique and that described in the literature. The protocol for selecting candidates for TEM, their preoperative preparation, equipment, characteristics of the surgical technique, postoperative complications, and follow-up are described. The collaboration of a multidisciplinary team is essential when developing this technique. TEM-associated morbidity is low and mortality is practically nil. TEM is the technique of choice in large rectal adenomas and malignant rectal tumors in stages pT1 localized in the rectal ampulla. The frequency of recurrence is similar to that in abdominal surgery. The technique does not cause complications of urinary or sexual dysfunction and fecal incontinence is minimal. In more advances stages of rectal cancer, the results of better patient selection and future studies on the possible application of neoadjuvant therapy associated with TEM are required (AU)