An analysis of randomized controlled trials on anal fistula conducted between 2000 and 2020 based on the Fragility Index and Reverse Fragility Index.

AIM: The aim of this work was to evaluate the robustness of randomized controlled trials (RCTs) on anal fistula management using the news tools of Fragility Index (FI), Reverse Fragility Index (RFI) and their corresponding fragility quotients. METHOD: A systematic search was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines which utilized MEDLINE, EMBASE, Cochrane Library and Web of Science databases. Inclusion criteria included RCTs related to the management of anal fistula published from 2000 to 2022 with dichotomous outcomes measures and 1:1 allocation. Calculation of FI and RFI was performed by creating 2 × 2 contingency tables by successively changing one nonevent to an event for each outcome measure until the result was made nonsignificant or significant, respectively. The Fragility Quotients were calculated by dividing the FI or RFI by the total sample size. Fragile results were defined as those with a FI or RFI equal to or less than the number of patients lost to follow-up. Additionally, those with a FI or RFI less than 3 were also considered fragile. Studies were considered extremely fragile if FI was ≤1 or FQ was ≤0.01. RESULTS: There were 36 RCTs that met our criteria, with 3223 patients. Among these, 19 (53%) were positive RCTs (p < 0.005) and 17 (47%) were negative RCTs (p > 0.05). The median FI was 2 (0-5). The analysis by categorical subgroup showed a strong correlation between FI and the p-value (p = 0.000) and the number of events (p = 0.011). The median RFI was 5 (3.5-9.5) and the subgroup analysis showed a strong correlation between RFI and the p-value (p = 0.000), sample size (0.021) and number needed to treat/number needed to harm (0.000). We considered 63.2% of positive RCTs to be fragile and 35.3% of negative RCTs. CONCLUSIONS: In the present study we demonstrated the lack of robustness of study findings in published RCTs in the field of anal fistula.

Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision.

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.

Subcuticular suture and incisional surgical-site infection in elective hepatobiliary and pancreatic surgery: an open-label, pragmatic randomized clinical trial (CLOSKIN trial).

BACKGROUND: Subcuticular suture has proven to reduce superficial incisional SSI (si-SSI) in clean surgery. However, question remains regarding clean-contaminated procedures. The aim of this study is to assess if subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery. METHODS: Single-centre, open-label, parallel, pragmatic randomized clinical trial conducted at a referral tertiary Hospital between January 2020 and April 2022. Patients eligible for elective HBP surgery were randomly assigned (1:1) to subcuticular suture or surgical staples wound closure using a minimisation method based on previously confirmed risk factors. The primary endpoint was the incidence of si-SSI. Considered secondary endpoints were major postoperative morbidity in both groups, additional wound complications, median hospital length of stay and need for re-hospitalisation. RESULTS: Of the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n = 173) or subcuticular suture (n = 173). After further exclusion of 11 participants, 167 and 168 patients, respectively in the control and the experimental group received their allocated intervention. For the primary endpoint, no significant differences in si-SSI rate were found: 17 (9.82%) staples group vs. 8 (4.62%) in subcuticular suture group (p = 0.062). Subset analysis confirmed absence of significant differences. As for secondary endpoints, overall wound complications did not differ significantly between two procedures: 19 (10.98%) vs. 10 (6.35%) (p = 0.127). There were no treatment related adverse events. However, occurrence of si-SSI contributed to major postoperative morbidity in both groups (p < 0.001 and p = 0.018) and to a substantially prolonged postoperative hospitalization (p = 0.015). CONCLUSIONS: Subcuticular suture might offer a relative benefit for skin closure reducing incidence of si-SSI after elective HBP surgery, although this was found not to be clinically relevant. Yet, this should not be interpreted as equivalence among both treatments. Therefore, wound closure strategy should not be based only on these grounds. TRIAL REGISTRATION NUMBER: ISRCTN Registry number ISRCTN37315612 (registration date: 14/01/2020).

Gender differences in stage at diagnosis and preoperative radiotherapy in patients with rectal cancer.

BACKGROUND: Few studies have examined gender differences in the clinical management of rectal cancer. We examine differences in stage at diagnosis and preoperative radiotherapy in rectal cancer patients. METHODS: A prospective cohort study was conducted in 22 hospitals in Spain including 770 patients undergoing surgery for rectal cancer. Study outcomes were disseminated disease at diagnosis and receiving preoperative radiotherapy. Age, comorbidity, referral from a screening program, diagnostic delay, distance from the anal verge, and tumor depth were considered as factors that might explain gender differences in these outcomes. RESULTS: Women were more likely to be diagnosed with disseminated disease among those referred from screening (odds ratio, confidence interval 95% (OR, CI = 7.2, 0.9-55.8) and among those with a diagnostic delay greater than 3 months (OR, CI = 5.1, 1.2-21.6). Women were less likely to receive preoperative radiotherapy if they were younger than 65 years of age (OR, CI = 0.6, 0.3-1.0) and if their tumors were cT3 or cT4 (OR, CI = 0.5, 0.4-0.7). CONCLUSIONS: The gender-specific sensitivity of rectal cancer screening tests, gender differences in referrals and clinical reasons for not prescribing preoperative radiotherapy in women should be further examined. If these gender differences are not clinically justifiable, their elimination might enhance survival.

A teaching project on rectal cancer and concentration of procedures: a comparison of oncological results between Catalonia and the rest of autonomous communities.

INTRODUCTION: the goal of this study was to compare the oncological results (local recurrence, metastasis and overall survival) obtained by the Proyecto Docente del Cáncer de Recto of the Spanish Association of Surgeons (AEC) (Proyecto Vikingo, PV) in Catalonia versus the rest of Spanish autonomous communities. METHODS: the PV database includes 4,508 patients who underwent a curative resection between March 2006 and December 2010, from the first 59 hospitals included in PV; 1,163 were from Catalonia and 3,345 were from the rest of Spain. There was a minimum follow-up of five years. RESULTS: in Catalonia, the five-year cumulative incidence was 8% (95% CI: 6.4-9.9) for local recurrence, 17.7% (95% CI: 15.4-20.2) for metastasis and 75% (95% CI: 72.4-77.7) for overall survival. In the rest of autonomous communities, these figures were 7% (95% CI: 6.2-8.2) for local recurrence, 22.3% (95% CI: 20.7-23.9) for metastasis, and 71% (95% CI: 69.4-72.9) for overall survival. Variables associated with tumor recurrence in PV included Hartmann's procedure, intraoperative perforation and circumferential margin involvement. CONCLUSION: the results obtained by the Proyecto Docente del Cáncer de Recto were homogeneous between Catalonia and the rest of the autonomous communities.

Oncological results of the educational Rectal Cancer Project in Spain 10 years after its implementation. / Resultados oncológicos del Proyecto docente del Cáncer de Recto en España 10 años después de su inicio.

INTRODUCTION: The objective of this observational, prospective, multicenter and multilevel study was to evaluate the oncological outcomes (local recurrence, metastasis and overall survival) of the Rectal Cancer Project of the Spanish Association of Surgeons (AEC) 10 years after its initiation, comparing the results with Scandinavian registries. METHODS: The AEC teaching project database includes 17,620 patients to date, of which 4,508 were operated on with a potentially curative resection between March 2006 and December 2010. All of them come from the first 59 hospitals included in the project, and therefore followed for at least 5 years, and are the subject of the present study. RESULTS: The cumulative incidence of local recurrence was 7.3 (95% CI: 8.2-6.5), metastasis 21.0 (CI 95%: 22.4-19.7) and overall survival 72.3 (CI 95%: 80.3-77.6). The multilevel regression analysis with the hospital variable as a random effect, showed a significant variation among the hospitals for the cancer outcome variables: general survival, local recurrence and metastasis (δ2=0.053). CONCLUSIONS: This study indicates that the results observed in the AEC' Rectal Cancer Project are inferior than those observed in the Scandinavian registries that we tried to emulate and that this is attributable to the variability of practice in some centers.

Anal intraepitelial neoplasia: A narrative review.

Anal intraepitelial neoplasia (AIN) constitutes a major health problem in certain risk groups, such as patients with immunosuppression of varied origin, males who have sexual relations with other males, and females with a previous history of vaginal or cervical abnormalities in cytology. Its relationship with the human papillomavirus (HPV) infection has been well documented; however, many of the factors involved in the progression and regression of the viral infection to dysplasia and anal carcinoma are unknown. AIN can be diagnosed through cytology of the anal canal or biopsy guided by high-resolution anoscopy. However, the need for these techniques in high-risk groups remains controversial. Treatment depends on the risk factors and given the high morbidity and high recurrence rates the utility of the different local treatments is still a subject of debate. Surgical biopsy is justified only in the case of progression suggesting lesions. The role of the vaccination in high-risk patients as primary prevention has been debated by different groups. However, there is no general consensus on its use or on the need for screening this population.

«Fast track¼ and intestinal surgery for Crohn's disease: Factors associated with prolonged hospital stay. / Rehabilitación multimodal y cirugía intestinal por enfermedad de Crohn: Factores asociados a estancia hospitalaria prolongada.

OBJECTIVE: The aim of this study was to determine factors associated with a prolonged postoperative stay (PS) in patients operated on with bowel resection for Crohn's disease (CD) included in an enhanced recovery program (ERP). METHODS: We included patients operated on for CD between January 2013 and December 2015. ERP was organized following an 8-point protocol. Variables studied were: age, sex, PS, ASA, location and type of CD, presence of perianal disease, Harvey-Bradshaw index, previous resection, type of surgery (minimally invasive vs. laparotomy) and Clavien Dindo. An inferential study was performed to identify factors related with a PS> 6 days and multivariate analysis. RESULTS: A total of 52 patients were operated on. The median PS was 8 days (IR: 5-11). In the univariate analysis, location (L1 vs. L2-3), type (B2 vs. B3), presence of perianal disease, prior surgery, type of surgery performed, Harvey-Bradshaw index and Clavien-Dindo were associated with a PS>or< than 6 days. The model that best adjusts to predict a PS> 6days contained the variable Harvey-Bradshaw (OR: 6,49; 95% CI: 1,46-28,8) and the type of surgery (OR: 0,23; 95%CI: 0,05-0,95). CONCLUSION: A prolonged postoperative stay after bowel resection for CD is more related to the type or severity of the disease and the type of surgery performed, than with other patient factors. Patients with CD need good coordination between prehabilitation, ERP and postoperative management.

Incidence and characterization of the anterior resection syndrome through the use of the LARS scale (low anterior resection score).

INTRODUCTION: Recently a score (LARS) has been internationally validates that quantifies the anterior resection syndrome (ARS). The objective of this study is to know the incidence and severity of the ARS using LARS and its correlation with selected variables or risk factors. METHODS: All operated patients with anterior resection for rectal cancer between October 2007 and February 2014, with curative intention and at least one year of functionality, were sent a LARS questionnaire. The variables studied were: Age sex, time elapsed since surgery, type of surgical approach, type of anastomosis, derivative ileostomy, postoperative pelvic complication, and radiotherapy regimen. RESULTS: Out of 195 patients, 136 (70%) responded, and 132 responded properly. A total of 47% of the patients presented "severe" LARS and 34% did not develop quantifiable ARS. Quality of life was worse in the highest LARS scores (P=.002). In the univariate analysis, total mesorectal excision, long radiotherapy regimen and derivative stoma were associated to "severe" LARS and the use of a reservoir was associated with minor LARS. In multivariate analysis only the type of resection (P<.001) and the use of a reservoir (P=.002) were individual factors related to LARS. CONCLUSIONS: Half of the operated patients presented high LARS score and only a third did not provide a quantifiable ARS. The overall perception of quality of life was significantly worse in patients with more severe LARS. The absence of the rectum (total mesorectal excision) and the type of anastomosis were the main factors associated with the LARS score.

[Pancreatic metastases due to renal carcinoma. Our cases and a literature review]. / Metástasis pancreáticas por carcinoma renal. Nuestra casuística y revisión de la literatura.

OBJECTIVE: To analyse the cases of pancreatic metastases due to renal carcinoma operated on in our hospital between the years 2000 and 2011. MATERIAL AND METHODS: A retrospective study using the variables of 8 patients who were subjected to surgery of pancreatic metastases due to renal carcinoma, and a comparison of our data with those from the literature. RESULTS: The incidence of metastatic disease of the pancreas due to renal carcinoma in our series was 1.2%. All the metastases were metachronous, with both sexes being affected equally. The mean time between resection of the renal tumour and the diagnosis of the metastasis was 12.42 years (range: 1.62-30.13 years). The therapeutic approach to the pancreatic lesions was surgical in all cases. Seven patients are currently still alive. CONCLUSION: Metastatic disease of the pancreas due to renal carcinoma is uncommon (1%-2.8%). The interval between the primary resection and the metastasis can be quite long. Pancreatic metastasis must always be suspected in patients who present with a pancreatic mass and a history of renal carcinoma. Aggressive surgical treatment is recommended in selected cases. The surgery in these cases improves survival and the quality of life.

[Radiation proctitis and chronic and refractory bleeding. Experience with 4% formaldehyde]. / Proctitis actínica, hemorrágica crónica y refractaria. Experiencia con formaldehído al 4%

INTRODUCTION: Bleeding is a common complication of proctitis secondary to radiotherapy of pelvic tumours. Between 5 and 10% may become severe and refractory to topical and endoscopic treatment. Experience with the application of 4% formaldehyde is presented. PATIENTS AND METHOD: A retrospective and descriptive study was performed on a patient cohort with severe radiation proctitis admitted to the Hospital Universitario Donostia between January 2003 and September 2009. All patients were diagnosed by colonoscopy and admitted due to the severity of their treatment. Both 4% formaldehyde and the gauze technique were used, as well as using enemas, in cases refractory to topical and endoscopic treatment with argon. The technique was performed in theatre with regional anaesthetic. Clinical and endoscopic follow up was carried out. RESULTS: The study included 25 males (73.5%) and 9 women (26.5%), with a mean age of 69 years (32-80) who had rectal bleeding due to radiation proctitis and required admission. All treatments failed in 6 (28.5%) patients, and 4% formaldehyde was used, with a complete response to the bleeding in all 6 patients, with 3 cases requiring one session, and the 3 others 2 sessions. The gauze technique was used in 4 patients and another 2 were given a formaldehyde enema due to the presence of stenosis. Pain appeared as the main complication in 2 (33.3%) patients. The median follow up was 60 months (interquartile range 26 to 67 months). CONCLUSIONS: The use of 4% formaldehyde in bleeding due to radiation proctitis is an effective, easy to reproduce technique, with a low morbidity.

Susceptibility genetic variants associated with early-onset colorectal cancer.

Colorectal cancer (CRC) is the second most common cancer in Western countries. Hereditary forms only correspond to 5% of CRC burden. Recently, genome-wide association studies have identified common low-penetrant CRC genetic susceptibility loci. Early-onset CRC (CRC<50 years old) is especially suggestive of hereditary predisposition although 85-90% of heritability still remains unidentified. CRC<50 patients (n = 191) were compared with a late-onset CRC group (CRC>65 years old) (n = 1264). CRC susceptibility variants at 8q23.3 (rs16892766), 8q24.21 (rs6983267), 10p14 (rs10795668), 11q23.1 (rs3802842), 15q13.3 (rs4779584), 18q21 (rs4939827), 14q22.2 (rs4444235), 16q22.1 (rs9929218), 19q13.1 (rs10411210) and 20p12.3 (rs961253) were genotyped in all DNA samples. A genotype-phenotype correlation with clinical and pathological characteristics in both groups was performed. Risk allele carriers for rs3802842 [Odds ratio (OR) = 1.5, 95% confidence interval (CI) 1.1-2.05, P = 0.0096, dominant model) and rs4779584 (OR = 1.39, 95% CI 1.02-1.9, P = 0.0396, dominant model) were more frequent in the CRC<50 group, whereas homozygotes for rs10795668 risk allele were also more frequent in the early-onset CRC (P = 0.02, codominant model). Regarding early-onset cases, 14q22 (rs4444235), 11q23 (rs3802842) and 20p12 (rs961253) variants were more associated with family history of CRC or tumors of the Lynch syndrome spectrum excluding CRC. In our entire cohort, sum of risk alleles was significantly higher in patients with a CRC family history (OR = 1.40, 95% CI 1.06-1.85, P = 0.01). In conclusion, variants at 10p14 (rs10795668), 11q23.1 (rs3802842) and 15q13.3 (rs4779584) may have a predominant role in predisposition to early-onset CRC. Association of CRC susceptibility variants with some patient's familiar and personal features could be relevant for screening and surveillance strategies in this high-risk group and it should be explored in further studies.

[Multiple vertical ligatures: A new approach to the treatment of haemorrhoidal disease grade III. Safety and efficacy study]. / Ligaduras múltiples verticales: un nuevo enfoque en el tratamiento de la enfermedad hemorroidal grado III. Estudio de seguridad y eficacia.

INTRODUCTION: The elastic ligature is the most used method for the out-patient treatment of haemorrhoids, with excellent results in control of bleeding. However, the recurrences in prolapse vary between 15 and 40%. We propose a new method for applying the elastic ligatures. PATIENTS: A total of 17 patients with grade iii haemorrhoids were chosen for the vertical ligatures (VL). The first elastic band was placed 3 to 4 cm from the pectineal line and 1 or 2 more in the root of the haemorrhoid group. Another 34 randomly selected patients were used as a control group. Data collected included, demographic details, number of bands and sessions, pain scale, complications and results. The patients were followed up at week one, week 3, and 3 months and one year after the intervention. RESULTS: A total of 12 males and 5 females, with a median age of 46 years, were treated with VL. The median follow-up was 10 (from 8 to 19) months. A median of 3 sessions and 7 elastic bands were used, with 6 patients having moderate pain that required analgesic treatment. None of the patients needed urgent treatment for pain or bleeding. There was a complete response to bleeding in 15 patients (88.2%) and to prolapse in 14 (82.2%). Two patients required haemorrhoidectomy due to treatment failure. The measurements of therapeutic effect after one year were: number needed to treat (NNT) of 4 (95% CI, 2 to 22), for prolapse, and NNT of 4 (95% CI, 2 a 15), for bleeding. CONCLUSIONS: Elastic ligatures could become a new treatment option for Grade iii haemorrhoids, improving control of bleeding and prolapse.

Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients.

OBJECTIVE: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. METHOD: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P = 0.001), with smaller tumoral size (P = 0.044) and reported higher rates of substance abuse including tobacco use (P = 0.034) and parenteral drug consumption (P = 0.001). No differences were found in administered therapies (P = 301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P = 0.756) and DFS (65 vs. 68%; P = 0.338) were observed. CONCLUSION: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients.

Incidence and risk factors for de novo cholelithiasis after bariatric surgery.

INTRODUCTION: Obesity and rapid weight loss after bariatric surgery (BS) are risk factors for the development of cholelitiasis. The aim of this study is to know the incidence of the de novo symptomatic cholelitiasis (DNSC) after BS and to analyze the risk factors for its development. METHODS: Single-centre retrospective observational study of patients undergoing BS between January 2010 and December 2017. The incidence of DNSC has been studied and sex, age, comorbilities, surgical tecnique, initial BMI and percentage of excess BMI lost (%EBMIL) at 6th, 12th and 24th postoperative months have been analyzed. RESULTS: Among the 415 patients who underwent BS, 280 have been studied since they were not previously cholecystectomized and had a preoperative negative abdominal ultrasound. Twenty-nine developed DNSC (10,35%), with a remarkably higher increase in cumulative incidence during the first postoperative year (CI 5%, IC 95% 2,4-7,6). A higher percentage of excess BMI lost at the 6, 12 and 24 postoperative months was statistically significantly correlated with an increased risk of DNSC. CONCLUSIONS: Incidence of DNSC and cholecystectomy after BS are relatively high, mainly during rapid weight loss period and even more the higher the percentage of excess BMI lost is. Concomitant cholecystectomy during BS in case of preoperative cholelithiasis regardless of symptoms and the use of ursodeoxycholic acid during the period of greater risk for DNSC development are two therapeutic options to consider.

Early-rectal Cancer Treatment: A Decision-tree Making Based on Systematic Review and Meta-analysis.

Local excision (LE) has arisen as an alternative to total mesorectal excision for the treatment of early rectal cancer. Despite a decreased morbidity, there are still concerns about LE outcomes. This systematic-review and meta-analysis design is based on the "PICO" process, aiming to answer to three questions related to LE as primary treatment for early-rectal cancer, the optimal method for LE, and the potential role for completion treatment in high-risk histology tumors and outcomes of salvage surgery. The results revealed that reported overall survival (OS) and disease-specific survival (DSS) were 71%-91.7% and 80%-94% for LE, in contrast to 92.3%-94.3% and 94.4%-97% for radical surgery. Additional analysis of National Database studies revealed lower OS with LE (HR: 1.26; 95%CI, 1.09-1.45) and DSS (HR: 1.19; 95%CI, 1.01-1.41) after LE. Furthermore, patients receiving LE were significantly more prone develop local recurrence (RR: 3.44, 95%CI, 2.50-4.74). Analysis of available transanal surgical platforms was performed, finding no significant differences among them but reduced local recurrence compared to traditional transanal LE (OR:0.24;95%CI, 0.15-0.4). Finally, we found poor survival outcomes for patients undergoing salvage surgery, favoring completion treatment (chemoradiotherapy or surgery) when high-risk histology is present. In conclusion, LE could be considered adequate provided a full-thickness specimen can be achieved that the patient is informed about risk for potential requirement of completion treatment. Early-rectal cancer cases should be discussed in a multidisciplinary team, and patient's preferences must be considered in the decision-making process.

Trends and outcome of neoadjuvant treatment for rectal cancer: A retrospective analysis and critical assessment of a 10-year prospective national registry on behalf of the Spanish Rectal Cancer Project.

INTRODUCTION: Preoperative treatment and adequate surgery increase local control in rectal cancer. However, modalities and indications for neoadjuvant treatment may be controversial. Aim of this study was to assess the trends of preoperative treatment and outcomes in patients with rectal cancer included in the Rectal Cancer Registry of the Spanish Associations of Surgeons. METHOD: This is a STROBE-compliant retrospective analysis of a prospective database. All patients operated on with curative intention included in the Rectal Cancer Registry were included. Analyses were performed to compare the use of neoadjuvant/adjuvant treatment in three timeframes: I)2006-2009; II)2010-2013; III)2014-2017. Survival analyses were run for 3-year survival in timeframes I-II. RESULTS: Out of 14,391 patients,8871 (61.6%) received neoadjuvant treatment. Long-course chemo/radiotherapy was the most used approach (79.9%), followed by short-course radiotherapy ±â€¯chemotherapy (7.6%). The use of neoadjuvant treatment for cancer of the upper third (15-11 cm) increased over time (31.5%vs 34.5%vs 38.6%,p = 0.0018). The complete regression rate slightly increased over time (15.6% vs 16% vs 18.5%; p = 0.0093); the proportion of patients with involved circumferential resection margins (CRM) went down from 8.2% to 7.3%and 5.5% (p = 0.0004). Neoadjuvant treatment significantly decreased positive CRM in lower third tumors (OR 0.71, 0.59-0.87, Cochrane-Mantel-Haenszel P = 0.0008). Most ypN0 patients also received adjuvant therapy. In MR-defined stage III patients, preoperative treatment was associated with significantly longer local-recurrence-free survival (p < 0.0001), and cancer-specific survival (p < 0.0001). The survival benefit was smaller in upper third cancers. CONCLUSION: There was an increasing trend and a potential overuse of neoadjuvant treatment in cancer of the upper rectum. Most ypN0 patients received postoperative treatment. Involvement of CRM in lower third tumors was reduced after neoadjuvant treatment. Stage III and MRcN + benefited the most.

Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients. / Características y resultados oncológicos del carcinoma epidermoide de ano: análisis comparativo entre los pacientes inmunocompetentes y los inmunodeprimidos.

OBJECTIVE: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. METHOD: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P=0.001), with smaller tumoral size (P=0.044) and reported higher rates of substance abuse. including tobacco use (P=0.034) and parenteral drug consumption (P=0.001). No differences were found in administered therapies (P=301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P=0.756) and DFS (65 vs. 68%; P=0.338) were observed. CONCLUSION: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients.