Combination chemotherapy versus single-agent chemotherapy during preoperative chemoradiation for resectable rectal cancer.

BACKGROUND: Colorectal cancer represents 10% of all cancers and is the third most common cause of death in women and men. Almost two-thirds of all bowel cancers are cancers of the colon and over one-third (34%) are cancers of the rectum, including the anus. Surgery is the cornerstone for curative treatment of rectal cancer. Mesorectal excision decreases the rate of local recurrences; however, it does not improve the overall survival of people with locally advanced rectal cancer. There have been significant research efforts since the mid-1990s to optimise the treatment of rectal cancer. Based on the findings of clinical trials, people with T3/T4 or N+ rectal tumours are now being treated preoperatively with radiation and chemotherapy, mainly fluoropyrimidine. However, the incidence of distant metastases remains as high as 30%. Combination chemotherapy regimens, similar to those used in metastatic disease with the addition of oxaliplatin and irinotecan, have been tested to improve the prognosis of people with rectal cancer. OBJECTIVES: To compare outcomes (including overall survival, disease-free survival and toxicity) between two 5-fluorouracil-containing chemotherapy regimens in people with stage II and III rectal cancer who are receiving preoperative chemoradiation. SEARCH METHODS: We searched the Cochrane Colorectal Cancer Group Specialised Register (January 2015), the Cochrane Central Register of Controlled Trials (2015, Issue 1), Ovid MEDLINE (1950 to January 2015), Ovid EMBASE (1974 to January 2015) and LILACS (1982 to January 2015). We reviewed the reference lists of included studies, checked clinical trials registers and handsearched relevant journal proceedings. We applied no language or publication restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing single-agent chemotherapy (fluoropyrimidine) versus combination chemotherapy (fluoropyrimidine plus another agent including, but not limited to, oxaliplatin) during preoperative radiochemotherapy in people with resectable rectal cancer. DATA COLLECTION AND ANALYSIS: Two review authors (HMR, EMKS) independently extracted data and assessed trial quality. When necessary, we requested additional information and clarification of published data from the authors of individual trials. MAIN RESULTS: We included four RCTs involving 3875 people with resectable rectal cancer. In the preoperative period, the participants of these studies were randomised to receive chemoradiation either with a single fluoropyrimidine agent (capecitabine or 5-fluorouracil) or with a combination of drugs (fluoropyrimidine plus oxaliplatin). The only study that reported overall survival and disease-free survival found no significant differences between the intervention and control groups; we considered this evidence very low quality. For pathological complete response after preoperative treatment (ypCR) there was high quality evidence favouring the intervention group (odds ratio (OR) 1.23, 95% confidence interval (CI) 1.04 to 1.46), but there was also moderate quality evidence suggesting a higher risk for early toxicity in the intervention group (OR 2.07, 95% CI 1.31 to 3.27). Moderate to high quality evidence suggested that the control group had better compliance to radiotherapy (OR 0.32, 95% CI 0.14 to 0.75). There were no significant differences between groups in postoperative mortality within 60 days, postoperative morbidity, resection margins, abdominoperineal resection and Hartmann procedures. AUTHORS' CONCLUSIONS: There was very low quality evidence that people with resectable rectal cancer who receive combination preoperative chemotherapy have no improvements in overall survival or disease-free survival. There was high quality evidence that suggested that combination chemotherapy with oxaliplatin may improve local tumour control in people with resectable rectal cancer, but this regimen also caused more toxicity. The review included four RCTs but only one reported survival; therefore, we cannot make robust conclusions or useful clinical recommendations. The publication of more survival data from these studies will contribute to future analyses.

ANTECEDENTES: El cáncer colorrectal representa el 10% de todos los cánceres y es la tercera causa más frecuente de muerte en mujeres y hombres. Casi dos tercios de todos los cánceres intestinales son cánceres de colon y más de un tercio (34%) son cánceres del recto, incluido el ano. La cirugía es la base del tratamiento curativo del cáncer rectal. La escisión mesorrectal disminuye la tasa de recidivas locales; sin embargo, no mejora la supervivencia general de las personas con cáncer de recto localmente avanzado. Desde mediados de los años noventa se han realizado esfuerzos significativos de investigación para optimizar el tratamiento del cáncer rectal. Según los resultados de los ensayos clínicos, actualmente las personas con tumores rectales T3/T4 o N+ se tratan preoperatoriamente con radiación y quimioterapia, principalmente fluoropirimidina. Sin embargo, la incidencia de metástasis distantes todavía es tan alta como del 30%. Para mejorar el pronóstico de las personas con cáncer rectal se han probado regímenes de quimioterapia combinada, similares a los utilizados en la enfermedad metastásica con el agregado de oxaliplatino e irinotecán. OBJETIVOS: Comparar los desenlaces (incluida la supervivencia general, la supervivencia sin enfermedad y la toxicidad) entre dos regímenes de quimioterapia que contienen 5­fluorouracilo en personas con cáncer rectal estadio II y III que reciben quimiorradioterapia preoperatoria. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en el Registro especializado del Grupo Cochrane Colorrectal (Cochrane Colorectal Cancer Group) (enero de 2015), Registro Cochrane central de ensayos controlados (Cochrane Central Register of Controlled Trials) (2015, número 1), Ovid MEDLINE (1950 hasta enero de 2015), Ovid EMBASE (1974 hasta enero de 2015) y en LILACS (1982 hasta enero de 2015). Se revisaron las listas de referencias de los estudios incluidos, se verificaron los registros de ensayos clínicos y se hicieron búsquedas manuales en los resúmenes de revistas relevantes. No se aplicaron restricciones de idioma ni de publicación. CRITERIOS DE SELECCIÓN: Ensayos controlados aleatorizados (ECA) que compararon la quimioterapia de agente único (fluoropirimidina) versus la quimioterapia combinada (fluoropirimidina más otro agente que incluyó, pero no se limitó a oxaliplatino) durante la radioquimioterapia preoperatoria en personas con cáncer rectal resecable. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión (HMR, EMKS) de forma independiente extrajeron los datos y evaluaron la calidad de los ensayos. Cuando fue necesario, se solicitó información adicional y aclaraciones sobre los datos publicados de los autores de los ensayos individuales. RESULTADOS PRINCIPALES: Se incluyeron cuatro ECA con 3875 personas con cáncer rectal resecable. En el período preoperatorio, los participantes de estos estudios se asignaron al azar a recibir quimiorradioterapia con el agente único fluoropirimidina (capecitabina o 5­fluorouracilo) o con una combinación de fármacos (fluoropirimidina más oxaliplatino). El único estudio que informó sobre la supervivencia general y la supervivencia sin enfermedad no encontró diferencias significativas entre los grupos de intervención y control; esta evidencia se consideró de calidad muy baja. Para la respuesta patológica completa después del tratamiento preoperatorio (ypCR) hubo evidencia de calidad alta a favor del grupo de intervención (odds ratio [OR] 1,23; intervalo de confianza [IC] del 95%: 1,04 a 1,46), pero también hubo evidencia de calidad moderada que indicó un mayor riesgo de toxicidad temprana en el grupo de intervención (OR 2,07; IC del 95%: 1,31 a 3,27). Evidencia de calidad moderada a alta indicó que el grupo control tuvo un mejor cumplimiento de la radioterapia (OR 0,32; IC del 95%: 0,14 a 0,75). No hubo diferencias significativas entre los grupos en la mortalidad posoperatoria en el transcurso de 60 días, la morbilidad posoperatoria, los márgenes de resección, la resección abdominoperineal ni los procedimientos de Hartmann. CONCLUSIONES DE LOS AUTORES: Hubo evidencia de calidad muy baja de que las personas con cáncer rectal resecable que reciben quimioterapia combinada preoperatoria no tienen mejorías en la supervivencia general ni la supervivencia sin enfermedad. Hubo evidencia de calidad alta que indicó que la quimioterapia combinada con oxaliplatino podría mejorar el control tumoral local en las personas con cáncer rectal resecable, pero este régimen también provocó más toxicidad. La revisión incluyó cuatro ECA, pero sólo uno informó sobre la supervivencia; por lo tanto, no se pueden establecer conclusiones sólidas ni recomendaciones clínicas útiles. La publicación de más datos de la supervivencia de estos estudios contribuirá a futuros análisis.

Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances.

BACKGROUND: A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT. OBJECTIVES: To evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances. SEARCH METHODS: We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to January 2014, and contacted the main authors in the subject area. There was no language restriction in the search. SELECTION CRITERIA: We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by The Cochrane Collaboration. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%. MAIN RESULTS: We included 11 randomised controlled studies with 735 participants which produced 16 meta-analyses of outcome data. Meta-analysis indicated that the primary outcome of intervention failure, occurred in lower proportion of participants with PEG compared to NGT (RR 0.18, 95% CI 0.05 to 0.59, eight studies, 408 participants, low quality evidence) and this difference was statistically significant. For this outcome, we also subgrouped the studies by endoscopic gastrostomy technique into pull, and push and not reported. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, 90 participants). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, one study, 33 participants) techniques. We found no statistically significant difference in cases where the technique was not reported (RR 0.43, 95% CI 0.13 to 1.44, four studies, 285 participants).There was no statistically significant difference between the groups for meta-analyses of the secondary outcomes of mortality (RR 0.86, 95% CI 0.58 to 1.28, 644 participants, nine studies, very low quality evidence), overall reports of any adverse event at any follow-up time point (ITT analysis, RR 0.83, 95% CI 0.51 to 1.34), 597 participants, 6 studies, moderate quality evidence), specific adverse events including pneumonia (aspiration) (RR 0.70, 95% CI 0.46 to 1.06, 645 participants, seven studies, low quality evidence), or for the meta- analyses of the secondary outcome of nutritional status including weight change from baseline, and mid-arm circumference at endpoint, although there was evidence in favour of PEG for meta-analyses of mid-arm circumference change from baseline (MD 1.16, 95% CI 1.01 to 1.31, 115 participants, two studies), and levels of serum albumin were higher in the PEG group (MD 6.03, 95% CI 2.31 to 9.74, 107 participants).For meta-analyses of the secondary outcomes of time on enteral nutrition, there was no statistically significant difference (MD 14.48, 95% CI -2.74 to 31.71; 119 participants, two studies). For meta-analyses of quality of life measures (EuroQol) outcomes in two studies with 133 participants, for inconvenience (RR 0.03, 95% CI 0.00 to 0.29), discomfort (RR 0.03, 95% CI 0.00 to 0.29), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001) and social activities (RR 0.01, 95% CI 0.00 to 0.18) the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with social activities. However, there were no significant differences between the groups for pain, ease of learning to use, or the secondary outcome of length of hospital stay (two studies, 381 participants). AUTHORS' CONCLUSIONS: PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration. Future studies should include details of participant demographics including underlying disease, age and gender, and the gastrostomy technique.

Risk factors associated with outcome in liver retransplantation: multicentric study.

BACKGROUND/AIMS: To externally validate the predictive mathematical model of survival designed by Linhares et al. (2006). METHODOLOGY: This retrospective study was conducted on 217 individuals submitted to liver retransplantation from January 2000 to December 2008 in four European centers. The following variables were obtained on the recipient: age, creatinine, urgency of retransplantation and time between transplantation and retransplantation. The Kaplan-Meier survival curve and ROC curve were used to validate the mathematical model. RESULTS: The present results showed a similar pattern of survival compared to the study of Linhares et al. (2006) concerning the biological variations, when survival curves were compared for each of the four variables analyzed between both samples. When compared, the areas below the ROC curve (aROC) of derivation (0.733) and validation samples (0.593) presented significant difference (p = 0.005), revealing low relationship of sensitivity and specificity between the two curves. Similarity was observed in Kaplan-Meier survival curves. CONCLUSION: This study allowed external validation by the Kaplan-Meier survival curves of the predictive mathematical model of survival in liver retransplantation proposed by Linhares et al. (2006). However, validation through the ROC curve, the aROC, evidenced weak discrimination ability.

Intravenous versus inhalational anaesthesia for paediatric outpatient surgery.

BACKGROUND: Ambulatory or outpatient anaesthesia is performed in patients who are discharged on the same day as their surgery. Perioperative complications such as postoperative nausea and vomiting (PONV), postoperative behavioural disturbances and cardiorespiratory complications should be minimized in ambulatory anaesthesia. The choice of anaesthetic agents and techniques can influence the occurrence of these complications and thus delay in discharge. OBJECTIVES: The objective of this review was to evaluate the risk of complications (the risk of postoperative nausea and vomiting (PONV), admission or readmission to hospital, postoperative behavioural disturbances and perioperative respiratory and cardiovascular complications) and recovery times (time to discharge from recovery ward and time to discharge from hospital) comparing the use of intravenous to inhalational anaesthesia for paediatric outpatient surgery. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2013, Issue 8); MEDLINE (1948 to 1 October 2013); EMBASE (1974 to 1 October 2013); Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) (1982 to 1 October 2013). We also handsearched relevant journals and searched the reference lists of the articles identified. SELECTION CRITERIA: We included randomized controlled trials comparing paediatric outpatient surgery using intravenous versus inhalational anaesthesia. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted the data. When necessary, we requested additional information and clarification of published data from the authors of individual trials. MAIN RESULTS: We included 16 trials that involved 900 children in this review. Half of all the studies did not describe the generation of randomized sequence and most studies did not describe adequate allocation sequence concealment. The included studies showed variability in the types and combinations of drugs and the duration of anaesthesia, limiting the meta-analysis and interpretation of the results.For the induction and maintenance of anaesthesia there was a significant difference favouring intravenous anaesthesia with propofol; the incidence of PONV was 32.6% for sevoflurane and 16.1% for propofol (odds ratio (OR) 2.96; 95% confidence interval (CI) 1.35 to 6.49, four studies, 176 children, low quality evidence). The risk of postoperative behavioural disturbances also favoured intravenous anaesthesiaas the incidence was 24.7% for sevoflurane and 11.5% for propofol (OR 2.67; 95% CI 1.14 to 6.23, four studies, 176 children, very low quality evidence). There were no differences between groups in the risk of intraoperative and postoperative respiratory and cardiovascular complications (OR 0.75; 95% CI 0.27 to 2.13, three studies,130 children, very low quality evidence) and there was no difference in the time to recovery from anaesthesia and discharge from hospital. These results should be interpreted with caution due to heterogeneity between studies in the type and duration of operations, types of reported complications and the high risk of bias in almost all studies. Two studies (105 participants) compared halothane to propofol and showed heterogeneity in duration of anaesthesia and in the type of ambulatory procedure. For the risk of PONV the results of the studies were conflicting, and for the risks of intraoperative and postoperative complications there were no significant differences between the groups.For the maintenance of anaesthesia there was a significant difference favouring anaesthesia with propofol, with or without nitrous oxide (N2O), when compared to thiopentone and halothane + N2O (OR 3.23; 95% CI 1.49 to 7.02, four studies, 176 children, low quality evidence; and OR 7.44; 95% CI 2.60 to 21.26, two studies, 87 children, low quality evidence), respectively. For the time to discharge from the recovery room, there were no significant differences between groups. The studies were performed with different ambulatory surgeries and a high risk of bias.Four studies (250 participants) compared the induction of anaesthesia by the inhalational or intravenous route, with inhalational anaesthesia for maintenance, and found no significant differences between groups in all outcomes (the risk of PONV, behavioural disturbances, respiratory and cardiovascular complications and time to discharge from recovery room). Meta-analysis was not done in this comparison because of significant clinical heterogeneity.Readmission to hospital was not reported in any of the included studies. No other adverse effects were reported. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether intravenous anaesthesia with propofol for induction and maintenance of anaesthesia in paediatric outpatients undergoing surgery reduces the risk of postoperative nausea and vomiting and the risk of behavioural disturbances compared with inhaled anaesthesia. This evidence is of poor quality. More high-quality studies are needed to compare the different types of anaesthesia in different subsets of children undergoing ambulatory surgery.

Expression profiling using a cDNA array and immunohistochemistry for the extracellular matrix genes FN-1, ITGA-3, ITGB-5, MMP-2, and MMP-9 in colorectal carcinoma progression and dissemination.

Colorectal cancer dissemination depends on extracellular matrix genes related to remodeling and degradation of the matrix structure. This investigation intended to evaluate the association between FN-1, ITGA-3, ITGB-5, MMP-2, and MMP-9 gene and protein expression levels in tumor tissue with clinical and histopathological neoplastic parameters of cancer dissemination. The expression associations between ECM molecules and selected epithelial markers EGFR, VEGF, Bcl2, P53, and KI-67 have also been examined in 114 patients with colorectal cancer who underwent primary tumor resection. Quantitative real-time PCR and immunohistochemistry tissue microarray methods were performed in samples from the primary tumors. The gene expression results showed that the ITGA-3 and ITGB-5 genes were overexpressed in tumors with lymph node and distant metastasis (III/IV-stage tumors compared with I/II tumors). The MMP-2 gene showed significant overexpression in mucinous type tumors, and MMP-9 was overexpressed in villous adenocarcinoma histologic type tumors. The ECM genes MMP9 and ITGA-3 have shown a significant expression correlation with EGFR epithelial marker. The overexpression of the matrix extracellular genes ITGA-3 and ITGB-5 is associated with advanced stage tumors, and the genes MMP-2 and MMP-9 are overexpressed in mucinous and villous adenocarcinoma type tumors, respectively. The epithelial marker EGFR overactivity has been shown to be associated with the ECM genes MMP-9 and ITGA-3 expression.

Relationship between the expression of the extracellular matrix genes SPARC, SPP1, FN1, ITGA5 and ITGAV and clinicopathological parameters of tumor progression and colorectal cancer dissemination.

OBJECTIVE: To evaluate the relationship between the expression of the extracellular matrix (ECM) genes SPARC, SPP1, FN1, ITGA5 and ITGAV and the histopathologic parameters of neoplastic progression and colorectal carcinoma (CRC) dissemination. METHODS: A retrospective study was conducted in 114 patients with stage I-IV CRC who underwent primary tumor resection. Quantitative real-time PCR and immunohistochemistry (IHC) assays were performed in samples obtained from the primary tumors. The correlation between the expression of these markers and the expression of p53, Bcl-2, Ki67, epidermal growth factor receptor (EGFR) and vascular endothelial growth factor was assessed with the Spearman coefficient (r). RESULTS: The ITGAV gene was found to be significantly amplified in tumors with positive perineural invasion (p = 0.028). Expression of the SPARC, SPP1, FN1, ITGA5 and ITGAV genes did not correlate with TNM staging. A direct relationship between ITGAV and EGFR expression (r = 0.774; p < 0.001) was observed by IHC. CONCLUSIONS: ECM gene expression did not correlate with classical prognostic factors for CRC, but overexpression of the ITGAV gene and protein was correlated with an increased risk of perineural invasion. The relationship between ITGAV and EGFR expression suggests the possibility of crosstalk in this signal pathway.

Expression of integrin genes and proteins in progression and dissemination of colorectal adenocarcinoma.

BACKGROUND: This study aimed to evaluate the relationship between the expression levels of selected integrin genes and proteins and cell differentiation, TNM stage, histological type and other variables potentially associated with the progression and dissemination of colorectal carcinoma (CRC). METHODS: A total of 114 patients (63 men and 51 women) were treated for CRC between 2006 and 2009, including 25 (21.9%) TNM I, 39 (34.2%) TNM II, 34 (29.8%) TNM III, and 16 (14.1%) TNM IV. Regarding grade, 91 (79.8%) were grade II, 14 (12.2%) were grade III and nine (7.8%) were grade I. Reverse-transcription polymerase chain reaction (RT-PCR) and tissue microarray (TMA) methods were used to examine the expression levels of the genes ITGAV, ITGA3, ITGA5, ITGB5, and ITGA6, and their proteins, respectively. RESULTS: In relation to TNM staging, ITGB5 and ITGA3 were over-expressed in stages III versus I. These results were confirmed by TMA analysis. In terms of age, ITGA5 was under-expressed according to RT-PCR, but over-expressed by TMA in patients over 60 years, while ITGA5 gene and protein levels were increased in mucinous carcinomas. In addition ITGAV gene and protein levels were elevated in tumors with neural invasion, and ITGA6 gene and protein were over-expressed in cases with venous invasion. All these results were significant at P < 0.05. CONCLUSION: The results of this study suggest that over-expression of some integrins is associated with TNM III stage, increased risk of vascular and neural invasion, and mucinous histology in patients with CRC.

Co-expression of monocarboxylate transporter 1 (MCT1) and its chaperone (CD147) is associated with low survival in patients with gastrointestinal stromal tumors (GISTs).

Monocarboxylate transporters (MCTs) have been described to play an important role in cancer, but to date there are no reports on the significance of MCT expression in gastrointestinal stromal tumors (GISTs). The aim of the present work was to assess the value of MCT expression, as well as co-expression with the MCT chaperone CD147 in GISTs and evaluate their clinical-pathological significance. We analyzed the immunohistochemical expression of MCT1, MCT2, MCT4 and CD147 in a series of 64 GISTs molecularly characterized for KIT, PDGFRA and BRAF mutations. MCT1, MCT2 and MCT4 were highly expressed in GISTs. CD147 expression was associated with mutated KIT (p = 0.039), as well as a progressive increase in Fletcher's Risk of Malignancy (p = 0.020). Importantly, co-expression of MCT1 with CD147 was associated with low patient's overall survival (p = 0.037). These findings suggest that co-expression of MCT1 with its chaperone CD147 is involved in GISTs aggressiveness, pointing to a contribution of cancer cell metabolic adaptations in GIST development and/or progression.

Evaluation of the clinical and inflammatory responses in exclusively NOTES transvaginal cholecystectomy versus laparoscopic routes: an experimental study in swine.

BACKGROUND: The aim of this study was to evaluate the clinical and inflammatory responses to surgical trauma caused by the natural orifice transluminal endoscopic surgery (NOTES) transvaginal endoscopic procedure compared with those of the laparoscopic route. METHODS: Twenty-one female swine were divided into three groups of seven animals and subjected to cholecystectomy using laparoscopic, laparotomic, and exclusively NOTES transvaginal routes. A group of five animals served as a control. The animals were monitored during surgery to evaluate anesthetic/surgical time and the presence of complications, which were evaluated after surgery with respect to roaming time, feeding, and the presence of clinical occurrence Measurements of TNF-α, IL-1ß, IL-6, CRP, IFN-γ were obtained before and after surgery, on the second and seventh postoperative days, and when the animals were killed and necropsied. RESULTS: All procedures were successfully completed as proposed in each group. Perioperative complications consisted of only gallbladder perforation and hepatic bleeding. The anesthetic/surgical time was longer in the NOTES vaginal group (p < 0.001). The postanesthetic recovery time, roaming, nutrition, and clinical evolution were similar in all groups. IL-1ß and IL-6 were undetectable in all groups. Levels of TNF-α, CRP, and IFN-γ were similar among the groups. However, the evolution of the inflammatory process, measured as the difference between the peak dose and the basal dose of IFN-γ, was lower in the NOTES group than in the laparotomy group. In the necropsy findings, only adhesions were found, with no difference among the groups. CONCLUSIONS: The entirely NOTES transvaginal cholecystectomy was feasible and safe. The surgical time was greater for the NOTES vaginal route. The inflammatory response was similar among the groups based on the levels of CRP and IFN-γ. However, the evolution of the inflammatory process seems to have been shorter in the vaginal NOTES group than in the laparotomy group as demonstrated by the difference between the peak and basal doses of IFN-γ.

Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances.

BACKGROUND: A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT. OBJECTIVES: To evaluate the effectiveness and safety of PEG as compared to NGT for adults with swallowing disturbances, by updating our previous Cochrane review. SEARCH METHODS: We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to September 2011, as well as contacting main authors in the subject area. There was no language restriction in the search. SELECTION CRITERIA: We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment). DATA COLLECTION AND ANALYSIS: Review authors performed selection, data extraction and evaluation of methodological quality of studies. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%. MAIN RESULTS: We included nine randomised controlled studies. We did not identify new eligible studies published after our previous review literature search date (August 2009). Intervention failure occurred in 19/156 patients in the PEG group and 63/158 patients in the NGT group (RR 0.24, 95%CI 0.08 to 0.76, P = 0.01) in favour of PEG. There was no statistically significant difference between comparison groups in complications (RR 1.00, 95%CI 0.91 to 1.11, P = 0.93). AUTHORS' CONCLUSIONS: PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure is more effective and safe as compared to NGT. There is no significant difference of mortality rates between comparison groups, and pneumonia irrespective of underlying disease (medical diagnosis). Future studies should include previously planned and executed follow-up periods, the gastrostomy technique, and the experience of the professionals to allow more detailed subgroup analysis.

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Previous systematic reviews comparing stapled and handsewn colorectal anastomosis that are available in the medical literature have not shown either technique to be superior. An update of this systematic review was performed to find out if there are any data that properly answer this question. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis surgery. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH METHODS: A computerized search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE according to the strategies of the Colorectal Cancer Group of The Cochrane Collaboration. There were no limits upon language, date or other criteria. A revised search strategy was performed for this updated version of the review May 2011. SELECTION CRITERIA: All randomised controlled trials (RCTs) in which stapled and handsewn colorectal anastomosis techniques were compared. Participants were adult patients undergoing elective colorectal anastomosis surgery. The interventions were endoluminal circular stapler and handsewn colorectal anastomosis surgery. Outcomes considered were a) mortality; b) overall anastomotic dehiscence; c) clinical anastomotic dehiscence; d) radiological anastomotic dehiscence; e) stricture; f) anastomotic haemorrhage; g) reoperation; h) wound infection; i) anastomosis duration; and j) hospital stay. DATA COLLECTION AND ANALYSIS: Data were independently analysed by the two review authors (CBN, SASL) and cross-checked. The methodological quality of each trial was assessed by the same two authors. After searching the literature for this update, no study was added to those in the previous version of this review. Details of randomizations (generation and concealment), blinding, whether an intention-to-treat analysis was done or not, and the number of patients lost to follow-up were recorded. The analysis of the risk of bias was updated according to the software Review Manager 5.1. The results of each RCT were summarized on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by the characteristics of the participants, interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The risk difference (RD) method (random-effects model) and number needed to treat (NNT) for dichotomous outcome measures and weighted mean differences (WMD) for continuous outcomes measures, with the corresponding 95% confidence intervals (CI), were presented in this review. Statistical heterogeneity was evaluated using a funnel plot and the Chi(2) test. MAIN RESULTS: Of the 1233 patients enrolled in nine identified trials, 622 were treated with staples and 611 with manual suture. The following main results were obtained. a) Mortality, result based on 901 patients: RD -0.6%, 95% CI -2.8% to +1.6%. b) Overall dehiscence, result based on 1233 patients: RD 0.2%, 95% CI -5.0% to +5.3%. c) Clinical anastomotic dehiscence, result based on 1233 patients: RD -1.4%, 95% CI -5.2 to +2.3%. d) Radiological anastomotic dehiscence, result based on 825 patients: RD 1.2%, 95% CI -4.8% to +7.3%. e) Stricture, result based on 1042 patients: RD 4.6%, 95% CI 1.2% to 8.1%; NNT 17, 95% CI 12 to 31. f) Anastomotic haemorrhage, result based on 662 patients: RD 2.7%, 95% CI -0.1% to +5.5%. g) Reoperation, result based on 544 patients: RD 3.9%, 95% CI 0.3% to 7.4%. h) Wound infection, result based on 567 patients: RD 1.0%, 95% CI -2.2% to +4.3%. i) Anastomosis duration, result based on one study (159 patients): WMD -7.6 minutes, 95% CI -12.9 to -2.2 minutes. j) Hospital stay, result based on one study (159 patients): WMD 2.0 days, 95% CI -3.27 to +7.2 days. AUTHORS' CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis surgery, regardless of the level of anastomosis. There were no randomised clinical trials comparing these two types of anastomosis in elective conditions in the last decade. The relevance of this research question has possibly lost its strength where elective surgery is concerned. However, in risk situations, such as emergency surgery, trauma and inflammatory bowel disease, new clinical trials are needed.

Liver re-transplantation: internal validation of a predictive mathematical model of survival.

BACKGROUND/AIMS: Because of the worse results from re-transplantation, a model for determining the long-term survival has been previously developed. Its effectiveness had to be tested and validated, as proposed in this study, using a different sample population than the one used to build it. METHODOLOGY: Age, recipient creatinine, urgency of re-transplantation, interval between primary liver transplant and re-transplantation (RETx) of 92 patients that received first liver RETx, from a different sample of patients, in a different time period than those used to develop the initial model. The proposed mathematical model was used to predict survival at six months after undergoing liver RETx. We compared the areas under the ROC curves (AROC) corresponding to the two independent samples (derivation and validation samples). By the log-rank technique, the survival curves were also compared and classified into tertiles according to the risk scores of the original model: high risk (>32), medium risk (24-32) and low risk (<24). RESULTS: Age, creatinine, time between primary liver transplant and re-transplantation and the urgency with which patients were enrolled, had comparable survival curves among the derivation and validation samples. When comparing the AROC of the derivation (0.733) and validation (0.741) samples, there was no statistically significant difference (p=0.915), therefore sensitivity and specificity ratios between the two are similar. CONCLUSIONS: This study made it possible to internally validate the original model for predicting survival at six months after undergoing liver RETx, although an external validation still needs to be done.

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: The presence of bowel contents during colorectal surgery has been related to anastomotic leakage, but the belief that mechanical bowel preparation (MBP) is an efficient agent against leakage and infectious complications is based on observational data and expert opinions only.An enema before the rectal surgery to clean the rectum and facilitate the manipulation for the mechanical anastomosis is used for many surgeons. This is analysed separately OBJECTIVES: To determine the security and effectiveness of MBP on morbidity and mortality in colorectal surgery. SEARCH STRATEGY: Publications describing trials of MBP before elective colorectal surgery were sought through searches of MEDLINE, EMBASE, LILACS, IBECS and The Cochrane Library; by handsearching relevant medical journals and conference proceedings, and through personal communication with colleagues.Searches were performed December 1, 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) including participants submitted for elective colorectal surgery. Eligible interventions included any type of MBP compared with no MBP. Primary outcomes included anastomosis leakage - both rectal and colonic - and combined figures. Secondary outcomes included mortality, peritonitis, reoperation, wound infection, extra-abdominal complications, and overall surgical site infections. DATA COLLECTION AND ANALYSIS: Data were independently extracted and checked. The methodological quality of each trial was assessed. Details of randomisation, blinding, type of analysis, and number lost to follow up were recorded. For analysis, the Peto-Odds Ratio (OR) was used as the default (no statistical heterogeneity was observed). MAIN RESULTS: At this update six trials and a new comparison (Mechanical bowel preparation versus enema) were added. Altogether eighteen trials were analysed, with 5805 participants; 2906 allocated to MBP (Group A), and 2899 to no preparation (Group B), before elective colorectal surgery.For the comparison Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation results were:1. Anastomotic leakage for low anterior resection: 8.8% (38/431) of Group A, compared with 10.3% (43/415) of Group B; Peto OR 0.88 [0.55, 1.40].2. Anastomotic leakage for colonic surgery: 3.0% (47/1559) of Group A, compared with 3.5% (56/1588) of Group B; Peto OR 0.85 [0.58, 1.26].3. Overall anastomotic leakage: 4.4% (101/2275) of Group A, compared with 4.5% (103/2258) of Group B; Peto OR 0.99 [0.74, 1.31].4. Wound infection: 9.6% (223/2305) of Group A, compared with 8.5% (196/2290) of Group B; Peto OR 1.16 [0.95, 1.42].Sensitivity analyses did not produce any differences in overall results.For the comparison Mechanical Bowel Preparation (A) Versus Rectal Enema (B) results were:1. Anastomotic leakage after rectal surgery: 7.4% (8/107) of Group A, compared with 7.9% (7/88) of Group B; Peto OR 0.93 [0.34, 2.52].2. Anastomotic leakage after colonic surgery: 4.0% (11/269) of Group A, compared with 2.0% (6/299) of Group B; Peto OR 2.15 [0.79, 5.84].3. Overall anastomotic leakage: 4.4% (27/601) of Group A, compared with 3.4% (21/609) of Group B; Peto OR 1.32 [0.74, 2.36].4. Wound infection: 9.9% (60/601) of Group A, compared with 8.0% (49/609) of Group B; Peto OR 1.26 [0.85, 1.88]. AUTHORS' CONCLUSIONS: Despite the inclusion of more studies with a total of 5805 participants, there is no statistically significant evidence that patients benefit from mechanical bowel preparation, nor the use of rectal enemas. In colonic surgery the bowel cleansing can be safely omitted and induces no lower complication rate. The few studies focused in rectal surgery suggested that mechanical bowel preparation could be used selectively, even though no significant effect was found. Further research on patients submitted for elective rectal surgery, below the peritoneal verge, in whom bowel continuity is restored, and studies with patients submitted to laparoscopic surgeries are still warranted.

INTERVENTIONS FOR THE TREATMENT OF IRRITABLE BOWEL SYNDROME: A REVIEW OF COCHRANE SYSTEMATIC REVIEWS.

BACKGROUND: Irritable bowel syndrome (IBS) is a complex gastrointestinal disorder, whose understanding is relatively uncertain, and the treatment guidance decision still represents a challenge. OBJECTIVE: To identify and critically appraise systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) on the effects of interventions (pharmacological and non-pharmacological) for the treatment of IBS. METHODS: The search was conducted at the Cochrane Library in May 2020. The methodological quality of the SRs was evaluated by the AMSTAR-2 tool. RESULTS: Eight SRs with moderate to high quality were included, which addressed the treatments: (a) pharmacological: volume agents, antispasmodics, antidepressants and tegaserod; and (b) non-pharmacological: homeopathy, acupuncture, phytotherapy, biofeedback, psychological interventions and hypnotherapy. The results were favorable to antispasmodic drugs and antidepressants regarding the improvement of clinical symptoms. There was no difference between volume agents or tegaserod when compared to placebo. Acupuncture and homeopathy showed a little improvement in symptoms compared to placebo, but the certainty of this evidence was considered low to very low. Psychological interventions seem to improve the overall assessment of the patient and relief symptoms such as abdominal pain. However, there was no long-term follow-up of these patients. The results of the other treatments were considered uncertain due to the high risk of bias. CONCLUSION: Considering the low quality of the studies included in the SRs, pharmacological treatment with antispasmodics and antidepressants seems to be beneficial for patients with IBS. Among non-pharmacological interventions, psychological interventions seem to be beneficial. However, further clinical trials are recommended with greater methodological rigor to prove these findings.

Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances.

BACKGROUND: A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT. OBJECTIVES: To evaluate the effectiveness and safety of PEG as compared to NGT for adults with swallowing disturbances. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to August 2009, as well as contacting main authors in the subject area. There was no language restriction in the search. SELECTION CRITERIA: We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failures (feeding interruption, blocking or leakage of the tube, no adherence to treatment). DATA COLLECTION AND ANALYSIS: Review authors performed selection, data extraction and evaluation of methodological quality of studies. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I(2) > 50%. MAIN RESULTS: We included nine randomised controlled studies. Intervention failure occurred in 19/156 patients in the PEG group and 63/158 patients in the NGT group (RR 0.24 (95%CI 0.08 to 0.76, P = 0.01)) in favour of PEG. There was no statistically significant difference between comparison groups in complications (RR 1.00, 95%CI 0.91 to 1.11, P = 0.93). AUTHORS' CONCLUSIONS: PEG was associated to a lower probability of intervention failure, suggesting the endoscopic procedure is more effective and safe as compared to NGT. There is no significant difference of mortality rates between comparison groups, and pneumonia irrespective of underlying disease (medical diagnosis). Future studies should include previously planned and executed follow-up periods, the gastrostomy technique, and the experience of the professionals to allow more detailed subgroup analysis.

Metalloproteinases and colorectal cancer. Correlation of gene expression and clinical-pathological parameters.

PURPOSE: To analyze gene and protein expression of metalloproteinases 1, 2, 9, 11 and 16 and their correlation with clinicopathological variables in colorectal adenocarcinoma. METHODS: A retrospective study of 114 patients with colorectal adenocarcinoma treated surgically in the period 2006 to 2008 in Hospital de Câncer de Barretos - Fundação Pio XII. The evaluation of gene expression was performed by RT-PCR, and protein by immunohistochemistry. The analysis of gene expression was classified as overexpressed genes and poorly expressed (fold change of approximately 2, p<0.05). The positivity of the markers in the immunohistochemical study was performed by semi-quantitative analysis. The tissue of TMA (Tissue Microarray) was done by two independent pathologists. RESULTS: The gene expression validated by immuno - histochemical was MMP-1(p= 0.00 and 1.57 fold change) and MMP - 2 (p= 0.01 and - 1.84 to fold change) when correlated with the histological types mucinous and adenocarcinoma NOS, MMP9 (p=0.01 and fold change of 1.13) and MMP-16 (p=0.03 and 1.61 fold change) when compared with the histological types villous and adenocarcinoma NOS, MMP - 11 statistically significant in relation to male (p = 0.04 and 1.65 fold change). CONCLUSIONS: The MMPs 1, 2, 9, 11 and 16 gene and protein expression with statistical significance in at least one of the clinicopathological variables studied. Thus, we conclude that these MMPs have potential as a prognostic factor in colorectal adenocarcinoma.

Metalloproteinase-1, metalloproteinase-7, and p53 immunoexpression and their correlation with clinicopathological prognostic factors in colorectal adenocarcinoma.

AIM: The aim of this study was to analyze the immunoexpression of metalloproteinase-1, metalloproteinase-7, and p53 in colorectal adenocarcinoma, and to correlate this with clinicopathological prognostic factors. MATERIAL AND METHODS: Formalin-fixed paraffin-embedded tumor tissue from 82 patients was analyzed by means of immunohistochemistry, using the streptavidin-biotin method and the tissue microarray technique. Protein tissue expression was correlated with the variables of the degree of cell differentiation, stage, relapse-free survival, recurrence, survival, and specific mortality. RESULTS: All of the tumors were positive for metalloproteinase-1, while 50 (61%) were positive for metalloproteinase-7, and 32 (39%) were negative for the latter. For p53, 70 (85.4%) of the tumors were positive and 12 (14.6%) were negative. Correlation of the marker expressions separately and in conjunction did not produce any statistically significant data. CONCLUSION: The immunoexpression of metalloproteinase-1, metalloproteinase-7, and p53 did not correlate with recurrence, mortality, relapse-free survival, survival, degree of cell differentiation, or staging of colorectal cancer.

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: The presence of bowel contents during surgery has been related to anastomotic leakage, but the belief that mechanical bowel preparation (MBP) is an efficient agent against leakage and infectious complications is based on observational data and expert opinions only. OBJECTIVES: To determine the security and effectiveness of MBP on morbidity and mortality in colorectal surgery. SEARCH STRATEGY: Publications describing trials of MBP before elective colorectal surgery were sought through searches of MEDLINE, EMBASE, LILACS, and The Cochrane Library; by handsearching relevant medical journals and conference proceedings, and through personal communication with colleagues.Searches were performed March 13, 2008. SELECTION CRITERIA: Randomised controlled trials (RCTs) including participants submitted for elective colorectal surgery. Eligible interventions included any type of MBP compared with no MBP. Primary outcomes included anastomosis leakage - both rectal and colonic - and combined figures. Secondary outcomes included mortality, peritonitis, reoperation, wound infection, extra-abdominal complications, and overall surgical site infections. DATA COLLECTION AND ANALYSIS: Data were independently extracted and checked. The methodological quality of each trial was assessed. Details of randomisation, blinding, type of analysis, and number lost to follow up were recorded. For analysis, the Peto-Odds Ratio (OR) was used as the default (no statistical heterogeneity was observed). MAIN RESULTS: Four new trials were included at this update (total 13 RCTs with 4777 participants; 2390 allocated to MBP (Group A), and 2387 to no preparation (Group B), before elective colorectal surgery) .Anastomotic leakage occurred:(i) in 10.0% (14/139) of Group A, compared with 6.6% (9/136) of Group B for low anterior resection; Peto OR 1.73 (95% confidence interval (CI): 0.73 to 4.10).(ii) in 2.9% (32/1226) of Group A, compared with 2.5% (31/1228) of Group B for colonic surgery; Peto OR 1.13 (95% CI: 0.69 to 1.85). Overall anastomotic leakage occurred in 4.2% (102/2398) of Group A, compared with 3.4% (82/2378) of Group B; Peto OR 1.26 (95% CI: 0.941 to 1.69). Wound infection occurred in 9.6% (232/2417) of Group A, compared with 8.3% (200/2404) of Group B; Peto OR 1.19 (95% CI: 0.98 to 1.45). Sensitivity analyses did not produce any differences in overall results. AUTHORS' CONCLUSIONS: There is no statistically significant evidence that patients benefit from MBP. The belief that MBP is necessary before elective colorectal surgery should be reconsidered. Further research on patients submitted for elective colorectal surgery in whom bowel continuity is restored, with stratification for colonic and rectal surgery, is still warranted.

Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery.

BACKGROUND: Upper abdominal surgical procedures are associated with a high risk of postoperative pulmonary complications. The risk and severity of postoperative pulmonary complications can be reduced by the judicious use of therapeutic manoeuvres that increase lung volume. Our objective was to assess the effect of incentive spirometry (IS) compared to no therapy, or physiotherapy including coughing and deep breathing, on all-cause postoperative pulmonary complications and mortality in adult patients admitted for upper abdominal surgery. OBJECTIVES: To assess the effects of incentive spirometry compared to no such therapy (or other therapy) on all-cause postoperative pulmonary complications (atelectasis, acute respiratory inadequacy) and mortality in adult patients admitted for upper abdominal surgery. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 3), MEDLINE, EMBASE, and LILACS (from inception to July 2006). There were no language restrictions. SELECTION CRITERIA: We included randomized controlled trials of incentive spirometry in adult patients admitted for any type of upper abdominal surgery, including patients undergoing laparoscopic procedures. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. MAIN RESULTS: We included 11 studies with a total of 1754 participants. Many trials were of only moderate methodological quality and did not report on compliance with the prescribed therapy. Data from only 1160 patients could be included in the meta-analysis. Three trials (120 patients) compared the effects of incentive spirometry with no respiratory treatment. Two trials (194 patients) compared incentive spirometry with deep breathing exercises. Two trials (946 patients) compared incentive spirometry with other chest physiotherapy. All showed no evidence of a statistically significant effect of incentive spirometry. There was no evidence that incentive spirometry is effective in the prevention of pulmonary complications. AUTHORS' CONCLUSIONS: We found no evidence regarding the effectiveness of the use of incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. This review underlines the urgent need to conduct well-designed trials in this field. There is a case for large randomized trials of high methodological rigour in order to define any benefit from the use of incentive spirometry regarding mortality.

Understanding the Effects of Colostomy-induced Alterations on Cutaneous Immunity .

UNLABELLED:  Objective. This study describes the immunological response in the dermal layer of the peri-colostomic region, and identifies and quantifies the cellular elements present. METHODS: Forty-one patients with colostomies present for more than 8 weeks were included. Thirty-one patients were men (75.6%) and 10 were women (24.4%) with an average age of 49.9 years. Thirty-four patients (82.9%) were classified as surgical risk class I and 7 patients (17.1%) were classified as class II. The data were analyzed statistically using the Mann-Whitney, Kruskal-Wallis, and Dunn tests using 0.05 or 5%. RESULTS: Analysis of the immuno-cellular response regarding the time of permanence of the colostomy showed a significant frequency of T lymphocytes (pan T-CD3) in all the time periods in a significantly superior number (P < 0.001) than the B lymphocytes (CD20) and the T lymphocytes-natural killer (CD57). T-helper cells (CD4) were present in larger numbers in the first three periods. CONCLUSION: The presence of a colostomy for more than 8 weeks promotes the development of a chronic inflammation and an immuno-cellular response in the dermal layer of the peri-colostomy region. However, its intensity did not demonstrate a statistically significant difference based on time of colostomy existence. The immuno-cellular response in the peri-colostomic dermal area is composed of a major number of T lymphocytes (pan T-CD3) and T lymphocytes-helper (CD4), and is more numerous between the 16th and 20th weeks, whereas, less cellular activity was noted between the 30th and 50th weeks. .