Estudio observacional prospectivo unicéntrico sobre el efecto de la prehabilitación trimodal en cirugía colorrectal / A single-center prospective observational study on the effect of trimodal prehabilitation in colorectal surgery

INTRODUCCIÓN: Se ha diseñado un protocolo de prehabilitación trimodal con el objetivo de valorar si contribuye a disminuir la morbilidad postoperatoria, valorar el efecto de la prehabilitación en la estancia hospitalaria global y analizar la evolución de la capacidad funcional antes y después de cirugía. MÉTODOS: Estudio observacional unicéntrico con pacientes con cáncer colorrectal intervenidos quirúrgicamente con intención curativa después de un protocolo de prehabilitación trimodal. Se recoge morbilidad postoperatoria según el Comprehensive Complication Index y estancia hospitalaria, y se compara con una matriz histórica. También se recoge capacidad funcional antes y después de la aplicación del protocolo de prehabilitación. RESULTADOS: En comparación con la población histórica se consigue disminuir el Comprehensive Complication Index global de forma estadísticamente significativa de 13,2 a 11,5. Desglosando por tipo de morbilidad, todas disminuyen en porcentaje sin conseguir significación (infección espacio quirúrgico del 11,7 al 8,4%; infección nosocomial del 15,8 al 10%, y morbilidad médica del 8,6 al 4,2%). La estancia hospitalaria global pasa de 6 a 4 días y el porcentaje de pacientes que se preparan en casa disminuye de forma estadísticamente significativa en ambos casos. CONCLUSIONES: La prehabilitación trimodal puede contribuir a disminuir la morbilidad postoperatoria y la estancia hospitalaria global de los pacientes intervenidos de neoplasia colorrectal

INTRODUCTION: A trimodal prehabilitation protocol was designed with the aim to evaluate whether it contributes to reducing postoperative morbidity, to evaluate the effect of prehabilitation on overall hospital stay, and to analyze the evolution of functional capacity before and after surgery. METHODS: A single-center observational study of patients with colorectal cancer who underwent surgery with curative intent after a trimodal prehabilitation protocol. We collected data for postoperative morbidity according to the Comprehensive Complication Index and hospital stay, which were compared with a historical matrix. Functional capacity data were also collected before and after the application of the prehabilitation protocol. RESULTS: Compared to the historical population, the overall Comprehensive Complication Index was reduced from 13.2 to 11.5, which was statistically significant. Analyzed by morbidity type, all decreased in percentage, although without achieving significance (surgical site infection from 11.7% to 8.4%, nosocomial infection 15.8 to 10% and medical morbidity 8.6% to 4.2%). The overall hospital stay went from 6 to 4 days, and the decrease in the percentage of patients who prepared at home was statistically significant in both cases. CONCLUSIONS: Trimodal prehabilitation can contribute to lowering the postoperative morbidity and overall hospital stay of patients undergoing colorectal cancer surgery

A single-center prospective observational study on the effect of trimodal prehabilitation in colorectal surgery. / Estudio observacional prospectivo unicéntrico sobre el efecto de la prehabilitación trimodal en cirugía colorrectal.

INTRODUCTION: A trimodal prehabilitation protocol was designed with the aim to evaluate whether it contributes to reducing postoperative morbidity, to evaluate the effect of prehabilitation on overall hospital stay, and to analyze the evolution of functional capacity before and after surgery. METHODS: A single-center observational study of patients with colorectal cancer who underwent surgery with curative intent after a trimodal prehabilitation protocol. We collected data for postoperative morbidity according to the Comprehensive Complication Index and hospital stay, which were compared with a historical matrix. Functional capacity data were also collected before and after the application of the prehabilitation protocol. RESULTS: Compared to the historical population, the overall Comprehensive Complication Index was reduced from 13.2 to 11.5, which was statistically significant. Analyzed by morbidity type, all decreased in percentage, although without achieving significance (surgical site infection from 11.7% to 8.4%, nosocomial infection 15.8 to 10% and medical morbidity 8.6% to 4.2%). The overall hospital stay went from 6 to 4 days, and the decrease in the percentage of patients who prepared at home was statistically significant in both cases. CONCLUSIONS: Trimodal prehabilitation can contribute to lowering the postoperative morbidity and overall hospital stay of patients undergoing colorectal cancer surgery.

A scoring system to predict complex transanal endoscopic surgery.

BACKGROUND: Since the introduction of screening for colorectal cancer, the use of transanal endoscopic surgery (TEM) has become increasingly popular. However, the technical difficulty of this surgery varies widely. The few studies of learning curve in TEM have produced very disparate results. The aim of this study is to distinguish between straightforward and complex procedures, in order to refer more difficult cases to centers with greater experience. METHOD: Observational study with prospective data collection and retrospective analysis was carried out between June 2004 and January 2019. All TEMs performed on rectal tumors were included. The complexity of the procedure was defined according to the weighted mean surgical time for each surgeon. A predictive model of complexity was established, with a score higher than 5 indicating a complex lesion. RESULTS: During the study period, 773 TEMs were performed, 708 of which met the study's inclusion criteria. One hundred and three tumors were defined as complex. Predictors of complexity were as follows: male sex (OR: 1.78, 95% CI 1.1-2.9, score: 1), tumor size > 5 cm (OR: 5.1, 95% CI 3.2-8.2, score: 4), TEM for recurrence (OR: 6.3, 95% CI 2.3-16.7, score: 5), and distance from the upper margin of the tumor to the anal verge > 15 cm (OR: 1.6, 95% CI 0.96-2.7, score: 1). CONCLUSIONS: Rather than establishing the learning curve merely in terms of the number of TEM procedures performed, it is important to consider the surgical difficulty of the interventions. To this end, it is essential to differentiate simple TEMs from the complex ones.

Transanal endoscopic microsurgery in very large and ultra large rectal neoplasia.

BACKGROUND: Transanal endoscopic microsurgery (TEM) has become the treatment of choice for benign rectal lesions and early rectal cancer (T1). The size classification of rectal polyps is controversial. Some articles define giant rectal lesions as those larger than 5 cm, which present a significantly increased risk of complications. The aim of this study was to evaluate the feasibility of TEM in these lesions. METHODS: An observational descriptive study with prospective data collection evaluating the feasibility of TEM in large rectal adenomas was performed between June 2004 and September 2018. Patients were assigned to one of the three groups according to size: < 5 cm, very large (5-7.9 cm) and ultra-large (≥ 8 cm). Descriptive and comparative analyses between groups were performed. RESULTS: TEM was indicated in 761 patients. Five hundred and seven patients (66.6%) with adenoma in the preoperative biopsy were included in the study. Three hundred and nine out of 507 (60.9%) tumors < 5 cm, 162/507 (32%) very large tumors (5-7.9 cm) and 36/507 (7.1%) ultra-large tumors (≥ 8 cm) were reviewed. Morbidity increased with tumor size: 17.5% in tumors < 5 cm, 26.5% in those 5-7.9 cm, and 36.1% in those > 8 cm. Peritoneal perforation, fragmentation, free margins and stenosis were also more common in very large and ultra-large tumors (p < 0.001). There were no statistical differences between the groups in the definitive pathology (p = 0.38). CONCLUSIONS: TEM in these large tumors is associated with higher rates of morbidity, peritoneal perforation, free margins and stenosis. Although these tumors do not require total mesorectal excision and are eligible for TEM, the surgery must be carried out by experienced surgeons.

Transanal endoscopic micro-surgery in elderly and very elderly patients: a safe option? Observational study with prospective data collection.

BACKGROUND: Although the incidence of colorectal cancer increases with the patient's age, the elderly continue to be less likely to be scheduled for surgery. Transanal endoscopic micro-surgery (TEM) is a surgical alternative to total mesorectal excision (TME) in early stage rectal cancer and/or in selected patients that could decrease morbidity and mortality rates in this group of patients. Our main objective is to assess the safety and feasibility of TEM in elderly (75-84 years) and very elderly (≥ 85 years) patients. METHODS: Observational study was conducted with prospective data collection of all consecutive patients who underwent TEM between April 2004 and January 2017. Patients were assigned to groups according to age. Descriptive and comparative analyses between groups were performed. RESULTS: We analyzed 693 patients, 429 patients < 75 years (61.9%), 220 patients between the ages of 75 and 84 (31.7%), and 44 patients ≥ 85 years old (6.3%). The tendency in our series is to increase comorbidities with age. Palliative or consensus intent was more frequently performed in elderly (10.5%, 34/220), and very elderly (45.4%, 20/44), compared with the youngest (6.3%, 27/429), (p < 0.001). Global morbidity presented an increasing trend related to age from 20.3% in < 75 years, to 25.9% in elderly and 34.1% in very elderly. Surgical complications were recorded in 18.5% (128/693) of patients with no significant differences between groups. The most common one was rectal bleeding 16.1% (111/693). Significant differences were found in non-surgical complications, recorded in 7.3% (16/220) in the elderly, and 15.9% (7/44) in the group above 84 years (p = 0.013). CONCLUSIONS: TEM presents acceptable morbidity rates mainly due to non-surgical-related adverse effects in elderly and very elderly patients and may be a feasible and safe alternative in this population in both curative and non-curative indications.

Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer.

PURPOSE: Compared with the open approach, laparoscopic total mesorectal excision (TME) achieves faster patient recovery, reduces morbidity rates, and shortens hospital stay. However, in laparoscopic low anterior resection (L-LAR), conversion to open surgery is required in almost 20% of cases. Transanal TME (Ta-TME) combined with laparoscopy, also called hybrid natural orifice transluminal endoscopic surgery (NOTES), is a less invasive procedure that can overcome some of the limitations of laparoscopic rectal surgery. In this study, we aim to determine whether Ta-TME has a lower rate of conversion to open surgery than L-LAR, and thus achieves faster patient recovery without altering the pathological, functional, or oncological results. The main objective is to compare the results for conversion to open surgery between Ta-TME and L-LAR. METHODS: Multicenter, prospective randomized controlled study of patients diagnosed with rectal adenocarcinoma who will be randomly allocated to Ta-TME or L-LAR groups after the application of inclusion and exclusion criteria. The main endpoint is conversion to open surgery and the secondary endpoints are general morbidity and mortality and hospital stay. Demographic, surgical, and pathological variables will also be studied, along with quality of life and survival. A sample size of 53 patients per group is calculated. With an estimated loss of 10%, the final sample required will be 116 patients. CONCLUSIONS: Ta-TME achieves a lower conversion rate to open surgery than L-LAR, thus improving patient recovery and reducing overall morbidity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02550769. Registration no. Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 2014/064.

Transanal endoscopic surgery is effective and safe after endoscopic polypectomy of potentially malignant rectal polyps with questionable margins.

AIM: To determine the percentage of residual lesion observed in the pathology study of transanal endoscopic surgery (TEM) specimens after endoscopic polypectomy of malignant rectal polyps with questionable margins, and the need for further surgery. Secondary aims: to determine the morbidity and mortality associated with this procedure and to identify the percentage of recurrence after excision by TEM. METHODS: Observational study with prospective data collection of all patients undergoing TEM after endoscopic polypectomy for malignant rectal polyps or non-invasive high-grade neoplasia, from January 2004 to December 2016. An en bloc full-thickness wall excision of the scar was performed. Variables recorded: histology of TEM specimen, 30-day morbidity and mortality according to the Clavien-Dindo classification, need for salvage surgery and recurrence. RESULTS: Fifty out of 690 patients undergoing TEM during the study period (36 adenocarcinomas, five non-invasive high-grade neoplasias and 9 neuroendocrine tumors) were included. Post-surgery histology showed residual lesion in 21 (42%) patients: 7 neuroendocrine tumors, 10 adenomas and 4 adenocarcinomas (two pT1, one pT2 and one pT3). The pT2 and pT3 patients (4%) underwent salvage surgery. No recurrence was observed, and mean follow-up was 29.1Â ± 21.6 months. The 30-day morbidity rate was 14%, but 4/7 with Clavien-Dindo grade I. CONCLUSIONS: After endoscopic polypectomy of malignant rectal polyps with questionable margins, the presence of residual lesion in the pathology study of transanal resection specimens is high. TEM with full-thickness resection of these lesions is an appropriate treatment, allowing disease control and achieving minimal morbidity.

Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME).

PURPOSE: The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME), in many cases requires a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal verge, achieves minimal postoperative morbidity and mortality rates, and does not require an ostomy. The treatment of T2, N0, and M0 cancers remains controversial. Preoperative chemoradiotherapy (CRT) in association with TEM reduces local recurrence and increases survival. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with TEM compared with TME. METHODS: Prospective, multicenter, randomized controlled non-inferiority trial includes patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2 or T3-superficial N0-M0. Patients will be randomized to two areas: CRT plus TEM or radical surgery (TME). Postoperative morbidity and mortality will be recorded and patients will complete the quality of life questionnaires before the start of treatment, after CRT in the CRT/TEM arm, and 6 months after surgery in both arms. The estimated sample size for the study is 173 patients. Patients will attend follow-up controls for local and systemic relapse. CONCLUSIONS: This study aims to demonstrate the preservation of the rectum after preoperative CRT and TEM in rectal cancer stages T2-3s, N0, M0 and to determine the ability of this strategy to avoid the need for radical surgery (TME). TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.

Application of a modified Neff classification to patients with uncomplicated diverticulitis.

AIM: Severity of acute diverticulitis (AD) has traditionally been assessed using the Hinchey classification; however, this classification is predominantly a surgical one. The Neff classification provides an alternative classification based on CT findings. The aim of this study was to evaluate a modification of the Neff classification to select patients presenting with early-stage AD to receive outpatient management. METHOD: All patients with AD, presenting to a single unit, were prospectively studied. All patients underwent emergency abdominal CT and were assigned a Neff stage, including a modification (mNeff) to Neff Stage I. The Neff stages used were: Stage 0, uncomplicated diverticulitis; Diverticula, thickening of the wall, increased density of the pericolic fat; Stage I, locally complicated (our modification included substages Ia (localized pneumoperitoneum in the form of air bubbles) and Ib (local abscess); Stage II, complicated with pelvic abscess; Stage III, complicated with distant abscess; and Stage IV, complicated with other distant complications. Patients who presented with Stage 0 or Stage Ia were selectively managed as outpatients. Patients with comorbidity or the presence of the systemic inflammatory response syndrome (SIRS) were excluded. RESULTS: Between February 2010 and January 2013, 205 patients (mean age 59 years; age range 25-90 years) presented with AD. One-hundred and forty-nine met the radiological criteria for potential outpatient treatment. After applying the exclusion criteria, 68 were eventually assigned to an outpatient programme. Sixty-four (94%) successfully completed the outpatient treatment protocol; four patients were readmitted. CONCLUSION: Our mNeff classification allowed selected patients with AD to be successfully managed in an outpatient programme.