INDURG TRIAL Protocol: A Randomized Controlled Trial Using Indocyanine Green during Cholecystectomy in Acute Cholecystitis.

INTRODUCTION: Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries, and bile duct injury is one of its main complications. The use of real-time indocyanine green fluorescence cholangiography allows the identification of extrahepatic biliary structures, facilitating the procedure and reducing the risk of bile duct lesions. A better visualization of the bile duct may help to reduce the need for conversion to open surgery, and may also shorten operating time. The main objective of this study was to determine whether the use of indocyanine green is associated with a reduction in operating time in emergency cholecystectomies. Secondary outcomes are the postoperative hospital stay, the correct intraoperative visualization of the Calot's Triangle structures with the administration of indocyanine green, and the intraoperative complications, postoperative complications and morbidity according to the Clavien-Dindo classification. METHODS: This is a randomized, prospective, controlled, multicenter trial with patients diagnosed with acute cholecystitis requiring emergency cholecystectomy. The control group will comprise 220 patients undergoing emergency laparoscopic cholecystectomy applying the standard technique. The intervention group will comprise 220 patients also undergoing emergency laparoscopic cholecystectomy for acute cholecystitis with prior administration of indocyanine green. CONCLUSION: Due to the lack of published studies on ICG in emergency laparoscopic cholecystectomy, this study may help to establish procedures for its use in the emergency setting.

Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a minimally invasive surgical technique that tries to avoid conversion to open surgery. However, specific intraoperative complications and local recurrences have cast some doubt on the suitability of the technique. The primary endpoint of the present study was a composite outcome of conversion surgery. Secondary objectives were to assess postoperative recovery, and pathological and oncological outcomes. METHODS: This was a prospective, multicentre, randomized, controlled open-label study of patients diagnosed with mid and low rectal adenocarcinoma who underwent laparoscopic TaTME or laparoscopic total mesorectal excision (LaTME). The TaTME technique comprised intracorporeal resection and anastomosis. Main outcomes were conversion to open surgery. Secondary outcomes were postoperative morbidity, mortality, pathological, oncological results, and survival. Modified intention-to-treat (mITT) and per-protocol analyses were performed. RESULTS: The study was conducted between April 2015 and May 2021. Patients were randomized to the LaTME (57 patients) or TaTME (59) group. Fifty patients from the LaTME group and 55 from the TaTME group were eligible for mITT analysis. The procedure was converted to open surgery in 11 patients (11 per cent): 10 (20 per cent) in the LaTME group and 1 (2 per cent) in the laparoscopic TaTME group (difference 18.8, 95 per cent c.i. 30 to 7; P = 0.003). No significant differences were found in terms of postoperative recovery and morbidity at 30 days; nor were there significant differences in anastomotic leakage, although it was less common in laparoscopic TaTME. With a median follow-up of 39 months, there were three instances of local recurrence (6.1 per cent) in the LaTME group and one (1.8 per cent) in the laparoscopic TaTME group (95 per cent c.i. 60 to 69; P = 0.3). Registration number: NCT02550769 (http://www.clinicaltrials.gov). CONCLUSION: The conversion rate was significantly lower in laparoscopic TaTME than in LaTME. At centres with experienced surgeons, laparoscopic TaTME can avoid conversion to open surgery.

Multicentre, prospective, randomized control non-inferiority trial of bladder catheter management in colon surgery.

AIM: Perioperative bladder catheterization is a controversial issue. Most current recommendations are based on data from open surgery extrapolated to enhanced recovery after surgery or fast-track programmes ranging between 24 and 48 h. The aim of this study is to provide a rationale for reducing catheterization time while at the same time avoiding acute urine retention (AUR), in patients undergoing scheduled laparoscopic colon surgery. METHOD: This is a multicentre, prospective, controlled, randomized non-inferiority study of bladder catheter management in patients undergoing scheduled laparoscopic colon surgery, randomized into two groups: experimental (with catheter removal immediately after surgery) and control (with catheter removal 24 h post-surgery). The main outcome will be the development of AUR, and secondary outcomes the development of urinary infection within the first 30 days and hospital stay. Demographic, surgical and pathological variables will also be evaluated, especially the development of adverse effects assessed according to the Clavien scale and the Comprehensive Complication Index. Following the literature, we assume an incidence of AUR of 11% and a margin of non-inferiority (delta) of 8% and estimate that a sample size of 208 patients per group will be required (with an estimated 10% of losses per group). CONCLUSIONS: In this study we try to demonstrate that the bladder catheter can be removed immediately after scheduled laparoscopic colon surgery, without increasing acute urine retention. This measure would offers the benefits of earlier mobilization and reduces catheter-related morbidity.

Robotic left hemicolectomy with intracorporeal anastomosis: Description of the technique and initial results.

AIM: The aim was to describe the robot-assisted intracorporeal anastomosis technique in left colon surgery (rLCS) and report the initial results. METHOD: The rLCS was performed in 25 consecutive patients, starting with a Pfannenstiel incision and introducing a prepared anvil. The robot was docked and the affected segment resected. Colotomy was performed and the anvil was introduced in the proximal segment. End-to-end anastomosis was performed and reinforced. An air-leak test was performed. RESULTS: The results varied in terms of patient's age, American Society of Anesthesiologists grade, weight and the technique performed. Most patients had cancer. There was no suture failure or mortality, and the mean hospital stay was 3 days. CONCLUSIONS: The rLCS is a safe, reproducible technique with good initial results. Prospective studies should be performed to demonstrate its advantages.

Complex Procedures in Transanal Endoscopic Microsurgery: Intraperitoneal Entry, Ultra Large Rectal Tumors, High Lesions, and Resection in the Anal Canal.

Transanal endoscopic microsurgery (TEM) allows the local excision of rectal tumors and achieves lower morbidity and mortality rates than total mesorectal excision. TEM can treat lesions up to 18 to 20 cm from the anal verge, obtaining good oncological results in T1 stage cancers and preserving sphincter function. TEM is technically demanding. Large lesions (>5 cm), those with high risk of perforation into the peritoneal cavity, those in the upper rectum or the rectosigmoid junction, and those in the anal canal are specially challenging. Primary suture after peritoneal perforation during TEM is safe and it does not necessarily require the creation of a protective stoma. We recommend closing the wall defect in all cases to avoid the risk of inadvertent perforation. It is important to identify these complex lesions promptly to transfer them to reference centers. This article summarizes complex procedures in TEM.

Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.

OBJECTIVE: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics. SUMMARY OF BACKGROUND DATA: In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective. METHODS: A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms. RESULTS: Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18). CONCLUSIONS: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).

Completion Surgery in Unfavorable Rectal Cancer after Transanal Endoscopic Microsurgery: Does It Achieve Satisfactory Sphincter Preservation, Quality of Total Mesorectal Excision Specimen, and Long-term Oncological Outcomes?

BACKGROUND: Unfavorable adenocarcinoma after transanal endoscopic microsurgery requires "completion surgery" with total mesorectal excision. The literature on this procedure is very limited. OBJECTIVE: This study aims to assess the percentage of transanal endoscopic microsurgery that will require completion surgery. DESIGN: This is an observational study with prospective data collection and retrospective analysis from patients who were operated on consecutively. SETTINGS: The study was conducted at a single academic institution. PATIENTS: Patients undergoing transanal endoscopic microsurgery from June 2004 to December 2018 who later required total mesorectal excision were included. MAIN OUTCOME MEASURES: All the patients followed the same protocol: preoperative study, indication of transanal endoscopic microsurgery with curative intent, performance of transanal endoscopic microsurgery, and completion surgery indication 3 to 4 weeks after transanal endoscopic microsurgery. RESULTS: Seven hundred seventy-four patients underwent transanal endoscopic microsurgery, 622 with curative intent (group I: adenoma, 517; group II: adenocarcinoma, 105). Completion surgery was indicated in 64 of 622 (10.3%) patients: group I, 40 of 517 (7.7%) and group II, 24 of 105 (22.9%). After applying exclusion criteria, completion surgery was performed in 55 patients (8.8%). Abdominoperineal resection was performed in 23 (45.1%); the initial lesion was within 6 cm of the anal verge in 19 of these 23 (82.6%). The clinical morbidity rate (Clavien Dindo> II) was 3 of 51 (5.9%). Total mesorectal excision was graded as complete in 42 of 49 (85.7%). The circumferential resection margin was tumor-free in 47 of 50 (94%). Median follow-up was 58 months. Local recurrence was recorded in 2 of 51 (3.9%) and systemic recurrence was recorded in 7 of 51 (13.7%); 5-year disease-free survival was 86%. LIMITATIONS: The limitations are defined by the study's observational design and the retrospective analysis. CONCLUSION: The indication of completion surgery after transanal endoscopic microsurgery is low, but is higher in the indication of adenocarcinoma. Compared with initial total mesorectal excision, completion surgery requires a higher rate of abdominoperineal resection, but has similar postoperative morbidity, total mesorectal excision quality, and oncological results. See Video Abstract at http://links.lww.com/DCR/B423. CIRUGA COMPLEMENTARIA EN CNCER DE RECTO DESFAVORABLE DESPUS DE UNA TEM SE OBTIENE SATISFACTORIAMENTE PRESERVACIN DEL ESFNTER, CALIDAD DE MUESTRA DE ETM Y RESULTADOS ONCOLGICOS A LARGO PLAZO: ANTECEDENTES:El adenocarcinoma con evolución desfavorable luego de una de microcirugía endoscópica transanal (TEM) requiere "cirugía de finalización" con la excisión total del mesorecto. La literatura sobre este procedimiento es muy limitada.OBJETIVO:Evaluar el porcentaje de microcirugía endoscópica transanal que requerió cirugía completa.DISEÑO:Estudio observacional con recolección prospectiva de datos y análisis retrospectivo de pacientes operados consecutivamente.AJUSTES:El estudio se realizó en una sola institución académica.PACIENTES:Aquellos pacientes sometidos a microcirugía endoscópica transanal desde junio de 2004 hasta diciembre de 2018 que luego requirieron excisón toztal del mesorecto.PRINCIPALES MEDIDAS DE RESULTADO:Todos los pacientes siguieron el mismo protocolo: estudio preoperatorio, indicación de microcirugía endoscópica transanal con intención curativa, realización de microcirugía endoscópica transanal e indicación de cirugía complementaria 3-4 semanas después de la microcirugía endoscópica transanal.RESULTADOS:Setecientos setenta y cuatro pacientes fueron sometidos a microcirugía endoscópica transanal, 622 con intención curativa (grupo I, adenoma: 517, grupo II, adenocarcinoma: 105). la cirugía complementaria fué indicada en 64/622 (10.3%), grupo I: 40/517 (7.7%) y grupo II 24/105 (22.9%). Después de aplicar los criterios de exclusión, la cirugía complementaria se realizó en 55 pacientes (8,8%). La resección abdominoperineal fué realizada en 23 (45,1%); en 19 de estos casos 23 (82,6%) la lesión inicial se encontraba dentro los 6 cm del margen anal. La tasa de morbilidad clínica (Clavien-Dindo > II) fue de 3/51 (5,9%). La excisión total del mesorecto se calificó como completa en 42/49 (85,7%). El margen de resección circunferencial se encontraba libre de tumor en 47/50 (94%). La mediana de seguimiento fue de 58 meses. La recurrencia local se registró en 2/51 (3.9%) y la recurrencia sistémica en 7/51 (13.7%); La supervivencia libre de enfermedad a 5 años fue del 86%.LIMITACIONES:Todas definidas por el diseño observacional y el análisis retrospectivo del mismo.CONCLUSIÓN:La indicación de completar la cirugía después de una TEM es baja, pero es más alta cuando la indicación es por adenocarcinoma. En comparación con la excisión total del mesorecto inicial, la cirugía complementaria requiere una tasa más alta de resección abdominoperineal, pero tiene una morbilidad postoperatoria, una calidad de excisión total del mesorecto y resultados oncológicos similares. ConsulteVideo Resumen en http://links.lww.com/DCR/B423. (Traducción-Dr. Xavier Delgadillo).

Minimal invasive surgery for left colectomy adapted to the COVID-19 pandemic: laparoscopic intracorporeal resection and anastomosis, a 'don't touch the bowel' technique.

AIM: The COVID-19 pandemic has forced surgeons to adapt their standard procedures. The modifications introduced are designed to favour minimally invasive surgery. The positive results obtained with intracorporeal resection and anastomosis in the right colon and rectum prompt us to adapt these procedures to the left colon. We describe a 'don't touch the bowel' technique and outline the benefits to patients of the use of less surgically aggressive techniques and also to surgeons in terms of the lower emission of aerosols that might transmit the COVID-19 infection. METHODS: This was an observational study of intracorporeal resection and anastomosis in left colectomy. We describe the technical details of intracorporeal resection, end-to-end stapled anastomosis and extraction of the specimen through mini-laparotomy in the ideal location. RESULTS: We present preliminary results of 17 patients with left-sided colonic pathologies, 15 neoplasia and two diverticular disease, who underwent four left hemicolectomies, six sigmoidectomies and seven high anterior resections. Median operating time was 186 min (range 120-280). No patient required conversion to extracorporeal laparoscopy or open surgery. Median hospital stay was 4.7 days (range 3-12 days). There was one case of anastomotic leak managed with conservative treatment. CONCLUSION: Intracorporeal resection and end-to-end anastomosis with the possibility of extraction of the specimen by a mini-laparotomy in the ideal location may present benefits and also adapts well to the conditions imposed by the COVID-19 pandemic. Future comparative studies are needed to demonstrate these benefits with respect to extracorporeal anastomosis.

Is Local Resection of Anal Canal Tumors Feasible with Transanal Endoscopic Surgery?

BACKGROUND: An important drawback of local surgery for lesions in the anal canal is the difficulty of achieving en bloc full-thickness resections. The aim of this study is to evaluate TEM/TEO in lesions of this type from the point of view of morbidity, mortality and the quality of the pathology specimen. METHODS: This is an observational study with prospective data collection from June 2004 to July 2018. Two groups are defined: group A (rectal tumors with proximal margin between 0 and ≤4 cm from anal verge) and group B (distal margin > 4 cm from anal verge). A technical description is provided; resections and postoperative complications in both groups are compared. RESULTS: During the study period, 757 patients underwent TEM/TEO. Finally, 692 patients were included, 192 patients in group A and 500 patients in group B. An en bloc surgical specimen was obtained in 176/192 patients (91.7%), although the defect was completely sutured in 132 (68.8%). In the comparative analysis, group A did not present significantly greater fragmentation of the resected piece [16/192 (8.3%) vs. 36/500 (7.2%), p = 0.630], although group A was associated with greater involvement of the surgical margin [28/192 (14.6%), 32/500 (6.4%), p = 0.001] and clinically relevant morbidity [16/192 (8.3%), 20/500 (4%), p = 0.034]. There was no mortality. CONCLUSIONS: The use of TEM/TEO to remove lesions originating in the anal canal is feasible. But we have to take into account that there is an increase in complications, technical difficulties and affected margins resection.

Multicenter Controlled Study of Intracorporeal Mechanical Side-to-Side Isoperistaltic Anastomosis versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-Study.

Colorectal cancer is the second most frequent cancer in the Western world. A third of colorectal tumors are located in the right colon, and right hemicolectomy is the treatment in nondisseminated right colon cancer. The most serious complication of this procedure is anastomotic leak, which occurs in 8.4% of cases. At present, there is no standardized technique for laparoscopic ileo-colic anastomosis. In previous observational studies, intracorporeal side-to-side ileo-colic laparoscopic anastomosis has shown better results than extracorporeal anastomosis in terms of morbidity and mortality. It is known that randomized studies provide higher levels of evidence, but multicenter randomized controlled studies may imply a learning curve bias due to the differences in technical experience acquired at each hospital. As a result, we propose to carry out a prospective, controlled, nonrandomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND) in a large sample of 416 patients (208 per group) in order to assess the use of intracorporeal side-to-side ileo-colic laparoscopic anastomosis as the gold standard in right hemicolectomy.

Perforation in the peritoneal cavity during transanal endoscopic microsurgery for rectal tumors: a real surgical complication with a challenging prognosis?

BACKGROUND: Perforation in the peritoneal cavity during transanal endoscopic microsurgery represents a major challenge. It is usually treated by primary suture, though some authors propose laparoscopic repair with or without ostomy. It is unclear whether perforation increases the risk of tumor dissemination. AIM: The purpose of the study is to assess the safety of primary suture of peritoneal perforation and the long-term risk of dissemination, also, to determine risk factors for perforation and to propose a predictive model for lesions with risk of perforation. METHOD: This is an observational study with prospective data collection at Parc Taulí University Hospital, Sabadell, of patients undergoing transanal surgery with perforation into the peritoneal cavity from June 2004 to September 2017. The main variable is postoperative morbidity and mortality. The long-term follow-up of local recurrence and peritoneal tumor dissemination is described, and a quantitative predictive model for peritoneal cavity perforation is proposed. RESULTS: Forty-five patients out of 686 (6.6%) presented perforation into the peritoneal cavity. Ten patients (22.2%) in the perforation group had morbidity, a rate similar to the non-perforated group. There was no peritoneal dissemination in patients with adenoma or with carcinoma treated with curative intent. In the quantitative predictive model, risk factors for perforation were proximal edge of tumor > 14 cm from anal verge (6 points), size ≥ 6 cm (2), age ≥ 85 years (4), anterior quadrant (3) , and sex (2). Total scores of ≥ 6 points predicted perforation. CONCLUSIONS: Primary suture after peritoneal cavity perforation during transanal surgery is safe and does not increase the risk of recurrence or peritoneal dissemination. Our predictive model provides guidance regarding the risk of perforation and the need to suture the defect after transanal surgery resection.

Morbidity after transanal endoscopic microsurgery: risk factors for postoperative complications and the design of a 1-day surgery program.

BACKGROUND: Transanal endoscopic microsurgery (TEM) is a minimally invasive procedure with low morbidity. The definition of risk factors for postoperative complications would help to identify the patients likely to require more care and surveillance in an ambulatory or 1-day surgery (A-OdS) program. The main endpoints are overall 30-day morbidity and relevant morbidity. The secondary objectives are to detect risk factors for complications, rehospitalization, and the time of occurrence of the postoperative complications, and to describe the adverse effects following hospitalization that the A-OdS program would avoid. METHODS: This is an observational study of consecutive patients undergoing TEM between June 2004 and December 2016. Overall and relevant morbidity based on the Clavien-Dindo (Cl-D) classification were recorded, as were demographic, preoperative, surgical, and pathology variables. Univariate and multivariate analyses of the risk factors were carried out. RESULTS: Six hundred and ninety patients underwent surgery, of whom 639 were included in the study. Overall morbidity rate was 151/639 patients (23.6%); the clinically relevant morbidity rate was 36/639 (Cl-D > II) (5.6%) and mortality 2/639 (0.3%). The most frequent complication was rectal bleeding, recorded in 16.9% (108/639 patients) and grade I in 86/108 patients (78. 9%). The period with the greatest risk of complications was the first 2 days. The rehospitalization rate after 48 h was 7%. The risk factors for complications were as follows: tumor size > 6 cm (OR 3.2, 95% CI 1.3-7.8), anti-platelet medication (OR 2.3, 95% CI 1.1-5.1), and surgeon's experience < 150 procedures (OR 2.0, 95% CI 1-4.1). CONCLUSIONS: TEM is a safe procedure. The low rates of morbidity, re-hospitalization, and postoperative complications in the first 2 days after surgery make the procedure suitable for A-OdS.

The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial.

BACKGROUND: Loop ileostomy reduces the rates of morbidity due to colorectal anastomotic dehiscence. For its part, ileostomy closure is associated with low mortality (0-4%) but substantial morbidity (11-37%). Incisional surgical site infection (SSI) is one of the most frequent complications (2-40%). METHODS: A single-center, prospective, randomized controlled clinical trial of two study groups: control (conventional primary skin closure) and experimental (primary skin closure with a contralateral Penrose® drain). RESULTS: Seventy patients undergoing loop ileostomy closure between April 2013 and June 2017 were included (35 per branch). Four were later removed from the study. Six of the remaining 66 patients (per protocol analysis) were diagnosed with incisional SSI (9.1%); there were no statistically significant differences between the two groups (control group: 9.7%; experimental group: 8.6%) or between the risk factors associated with incisional SSI. Rates of overall and relevant morbidity (Clavien ≥ III) were considerable (28.1% and 9.1%, respectively), and there were no statistically significant differences between the two groups. No patients died. CONCLUSION: Contralateral drainage does not significantly affect the results of primary ileostomy closure. The rate of incisional SSI was similar in the drainage and non-drainage groups, and the overall rate of 9.1% was in the low range of those reported in the literature. The absence of mortality (0%) and the non-negligible rates of overall and relevant morbidity (28.1% and 9.1%, respectively) in our series suggest that loop ileostomy is a safe procedure. However, the bowel reconstruction involves risks that must be borne in mind. CLINICAL TRIAL REGISTRATION: The study was registered and approved by the clinical research ethics committee of the study center (reference number 2012076). Clinical trial was registered in ClinicalTrial.gov (identification number NCT02574702 and reference: ILEOS-ISS_2013).

Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.

BACKGROUND: Total Mesorectal Excision (TME) is the standard surgical technique for the treatment of rectal cancer. However, rates of sexual dysfunction ofup to 50% have been described after TME, and rates of urinary dysfunction of up to 30%. Although other factors are involved, the main cause of postoperative genitourinary dysfunction is intraoperative injury to the pelvic autonomic nerves. The risk is particularly high in the inferior mesenteric artery (IMA). The aim of this study is to compare pre- and post-TME sexual dysfunction, depending on the surgical approach usedin the inferior mesenteric vessels: either directly on the IMA, or from the inferior mesenteric vein (IMV) to the IMA. METHODS: Prospective, randomized,controlled study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomly assigned to one of two groups depending on the surgical approach to the inferior mesenteric vessels. The main variable is pre- and postoperative sexual dysfunction; secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, and pre- and postoperative quality of life. The sample will comprise 90 patients, 45 per group. DISCUSSION: The aim is to demonstrate that the dissection route from the IMV towards the IMA favors the preservation of the pelvic autonomic nerves and thus reducesrates of sexual dysfunction post-surgery. TRIAL REGISTRATION: Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 017/315. ClinicalTrials.gov TAU-RECTALNERV-PRESERV-2018 (TRN: NCT03520088 ) (Date of registration 04/03/2018).

Endorectal ultrasound in the identification of rectal tumors for transanal endoscopic surgery: factors influencing its accuracy.

Endorectal ultrasound (ERUS) is considered the technique of choice for selecting patients for transanal endoscopic surgery (TEM). The aim of this study was to evaluate the accuracy of ERUS in patients with rectal tumors who later underwent TEM, and to analyze the factors that influence this accuracy. Observational study including prospective data collection of patients with rectal tumors undergoing TEM with curative intent between June 2004 and May 2016. Preoperative staging by EUS (uT) was correlated with the pathology results after TEM (pT). The accuracy of the EUS was evaluated and a series of variables (tumor morphology, height, lesion size, quadrant, definitive pathology, the surgeon assessing the ERUS, and waiting time from the date of the ERUS until surgery) were analyzed as possible predictors of diagnostic accuracy. Six hundred and fifty-one patients underwent TEM, of whom 495 met the inclusion criteria. The overall accuracy of EUS was 78%, sensitivity 83.78%, specificity 20%, PPV 91.3%, and NPV 11%. Forty patients (8.08%) were understaged and 50 (10.9%) were overstaged. In the multivariate analysis, the surgeon's experience emerged as the most important predictor of accuracy (p < 0.001; OR 2.75, 95% CI 1.681-4.512). The EUS was less accurate with larger lesions (p = 0.004; OR 0.219, 95% CI 0.137-0.349) and when the definitive diagnosis was adenocarcinoma (p < 0.001; OR 0.84, 95% CI 0.746-0.946). ERUS accuracy rates are variable and there is a possibility of understaging and overstaging that must be taken into consideration. This accuracy is dependent on the operator's experience as well on lesion size; in addition, it is lower for lesions shown to be cancers in the final pathology report.

Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics.

PURPOSE: Acute diverticulitis (AD) is a highly prevalent disease in Spain. Its chronic-recurrent appearance and high rate of relapse mean that it has a major epidemiological and economic impact on our health system. In spite of this, it has not been studied in any great depth. Reassessing its etiopathology, recent studies have observed that it is an inflammatory disease-not, as classic theories had postulated, an infectious one. In the light of these findings, the suitability of antibiotics for its treatment has been reconsidered. At present, however, the evidence for incorporating these findings into clinical practice guidelines remains insufficient. METHODS: This study was designed to analyse the safety and efficacy of a non-antibiotic treatment for mild AD. Patients with mild AD (grade 0 in the modified Neff classification) who meet the inclusion criteria will be randomly assigned to one of two outpatient treatment strategies: (a) classical treatment (antibiotics, anti-inflammatories and low-fibre diet) or (b) experimental treatment (anti-inflammatories and low-fibre diet). Clinical controls will be performed at 2, 7, 30, and 90 days. We will determine whether there are any differences in the clinical outcome between groups. The main objective is to demonstrate that antibiotics neither accelerate the resolution of the disease nor decrease the number of complications and/or recurrences in these patients, suggesting that their use may be unnecessary. CONCLUSIONS: The results of this trial will help to optimize and homogenize the treatment of this highly prevalent disease. However, more studies are required before firm changes can be introduced in international clinical practice guidelines. TRIAL REGISTRATION: The trial has been registered at the ClinicalTrials.gov database (ID: NCT02785549) and the EU Clinical Trials Register database (EudraCT number: 2016-001596-75).

The use of the modified Neff classification in the management of acute diverticulitis.

INTRODUCTION: Acute diverticulitis (AD) is increasingly seen in Emergency services. The application of a reliable classification is vital for its safe and effective management. OBJECTIVE: To determine whether the combined use of the modified Neff radiological classification (mNeff) and clinical criteria (systemic inflammatory response syndrome [SIRS] and comorbidity) can ensure safe management of AD. MATERIAL AND METHODS: Prospective descriptive study in a population of patients diagnosed with AD by computerized tomography (CT). The protocol applied consisted in the application of the mNeff classification and clinical criteria of SIRS and comorbidity to guide the choice of outpatient treatment, admission, drainage or surgery. RESULTS: The study was carried out from February 2010 to February 2016. A total of 590 episodes of AD were considered: 271 women and 319 men, with a median age of 60 years (range: 25-92 years). mNeff grades were as follows: grade 0 (408 patients 70.6%); 376/408 (92%) were considered for home treatment; of these 376 patients, 254 (67.5%) were discharged and controlled by the Home Hospitalization Unit; 33 returned to the Emergency Room for consultation and 22 were re-admitted; the success rate was 91%. Grade Ia (52, 8.9%): 31/52 (59.6%) were considered for outpatient treatment; of these 31 patients, 11 (35.5%) were discharged; eight patients returned to the Emergency Room for consultation and five were re-admitted. Grade Ib (49, 8.5%): five surgery and two drainage. Grade II (30, 5.2%): ten surgery and four drainage. Grade III (5, 0.9%): one surgery and one drainage. Grade IV (34, 5.9%): ten patients showed good evolution with conservative treatment. Of the 34 grade IV patients, 24 (70.6%) underwent surgery, and three (8.8%) received percutaneous drainage. CONCLUSIONS: The mNeff classification is a safe, easy-to-apply classification based on CT findings. Together with clinical data and comorbidity data, it allows better management of AD.

Neoadjuvant therapy and transanal endoscopic surgery in T2-T3 superficial, N0, M0 rectal tumors. Local recurrence, complete clinical and pathological response. / Neoadyuvancia y cirugía endoscópica transanal en neoplasias de recto T2-T3 superficial, N0, M0. Recidiva local, respuesta clínica y patológica completa.

INTRODUCTION: The association of preoperative chemoradiotherapy and transanal endoscopic surgery in T2 and superficial T3 rectal cancers presents promising results in selected patients. The main objective is to evaluate the long-term loco-regional and systemic recurrence and, as secondary objectives, to provide results of postoperative morbidity and the correlation between complete clinical and pathological response. METHODS: This is a retrospective observational study including a consecutive series of patients with T2-T3 superficial rectal cancer, N0, M0 who refused radical surgery (2008-2016). The treatment consisted of preoperative chemotherapy (5-fluorouracil or capecitabine) combined with radiotherapy (50, 4Gy) and transanal endoscopic surgery after 8weeks. Preoperative, surgical, pathological and long-term oncologic results were analyzed. RESULTS: Twenty-four patients were included in the study. Two of them required rescue radical surgery for unfavorable pathological results. A local recurrence (4.5%) was observed and 2patients presented systemic recurrence (9%), with a median follow-up of 45 months. A complete clinical tumor response was achieved in 12 patients (50%), and complete pathological tumor response in 9 patients (37.5%). Postoperative complications were observed in 5 patients (20.8%), and they were mild except one. There was no postoperative mortality. CONCLUSIONS: In this stage of rectal cancer, our results seem to support this strategy, mainly when a complete pathological response is achieved. The complete clinical tumor response does not coincide with the pathological tumor response. Randomized prospective studies should be performed to standardize this treatment.

Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis.

BACKGROUND: Laparoscopic surgery for rectal TME achieves better patient recovery, lower morbidity, and shorter hospital stay than open surgery. However, in laparoscopic rectal surgery, the overall conversion rate is nearly 20%. Transanal TME combined with laparoscopy, known as Hybrid NOTES, is a less invasive procedure that provides adequate solutions to some of the limitations of rectal laparoscopy. Transanal TME via TEO with technical variants (intracorporeal resection and anastomosis, TEO review of the anastomosis) attempts to standardize and simplify the procedure. METHOD: Prospective observational study was used describe and assess the technique in terms of conversion to open surgery, overall morbidity, surgical site infection and hospital stay. The sample comprised consecutive patients diagnosed with rectal tumor less than 10 cm from the anal verge who were candidates for low anterior resection using TME (except T4). Demographic, surgical, postoperative, and pathological variables were analyzed, as well as morbidity rates. RESULTS: From September 2012 to August 2014, 32 patients were included. The conversion rate was 0%. Overall morbidity was 31.3%, SSI rate was 9.4%, and mean hospital stay was 8 days. Oncological radical criteria were achieved with pathological parameters of 94% of complete TME and a median circumferential margin of 13 mm. CONCLUSION: The introduction of technical variants of TEO for transanal resection can facilitate a procedure that requires extensive experience in transanal and laparoscopic surgery. Studies of sphincter function, quality of life, and long-term oncological outcome are now necessary.