The management of patients undergoing colorectal surgery has changed in recent decades. Efforts have been made to show that perioperative physiological stress to the patient can be minimised with standardised care programmes and thus improve short term outcome after colorectal surgery. Mechanical bowel preparation (MBP), for instance, has been questioned as part of standard management. There are studies highlighting the effect of cancer treatment and its side effects in the elderly, showing that geriatric patients benefit from oncological therapy in much the same way as younger patients. The impact of this information on surgical and oncological practice in Sweden today is not known. To assess the effectiveness of colorectal surgery we need both randomised controlled trials and population-based cohort studies. We have performed a trial on colonic surgery with and without preoperative mechanical bowel preparation, as well as a nation-wide register study comparing treatment and outcome of rectal cancer in two age groups. In a randomised controlled trial 1505 patients from 21 hospitals were randomised to MBP or no-MBP prior to open elective colonic resection. There were no differences in overall complication rates between the groups: cardiovascular 5.1% with MBP vs. 4.6% without MBP; general infection 7.9% vs. 6.8%; and surgical site complications 15.1% vs. 16.1%. The proportion of patients reaching at least one primary endpoint was 24.5% vs. 23.7% respectively. The patients experience of and postoperative recovery after MBP or no-MBP was evaluated in 105 of the patients in the bowel preparation trial at three of the participating hospitals. Sixty-five patients received MBP and 40 patients did not. In the MBP group 52% needed assistance with bowel preparation. Day 4 postoperatively patients in the no-MBP group perceived more discomfort than patients in the MBP group, p<0.05. Bowel emptying occurred significantly earlier in the no-MBP group than in the MBP group, p<0.05. In an experimental study the effect of MBP on intramucosal bacterial count was evaluated. Macroscopically normal colon mucosa was collected from 37 patients (20 MBP and 17 No-MBP) undergoing elective colorectal surgery at three hospitals. MBP did not influence the median colony count of E. coli, Bacteroides, or total median colony count, information that was previously unknown. These three studies imply that MBP can be omitted before elective colonic resection. In a population-based register study, treatment for rectal cancer in patients ≥ 75 years and those < 75 years was evaluated using data from the Swedish Rectal Cancer Register 1995-2004 (N=15104). This study revealed that preoperative radiotherapy was used less in patients > 75 years. There was also a higher threshold for surgery in this group, and they more often received a permanent stoma compared to younger patients. Outcome in terms of 5-year local recurrence rate and 5-year cancer-specific survival differed very little between the older and younger patient groups who underwent abdominal tumour resection with curative intent. We suggest future studies focusing on ways of reducing surgical and perioperative stress and on quality of life when assessing suitable treatment modalities for rectal cancer.

FundaÃÃo de Amparo à Pesquisa do Estado do Cearà / O estudo anastomose colorretal desperta interesse por apresentar morbidade e mortalidade elevadas. Isso ocorre principalmente, por deiscÃncia, atribuÃda a vÃrios fatores, inclusive inflamatÃrios. A aroeira-do-sertÃo (Myracrodruon urundeuva Fr. All.), Ãrvore da famÃlia Anacardiaceae, à conhecida pelas suas propriedades antiinflamatÃrias e cicatrizantes, surgindo como uma alternativa terapÃutica. Diante dessas qualidades conhecidas, decidiu-se verificar sua aÃÃo na anastomose cÃlica na vigÃncia da colite experimental induzida por Ãcido acÃtico a 10%, em ratos Wistar. Foram utilizados 48 ratos, machos, com peso mÃdio de 340g, distribuÃdos em dois grupos de 24. Um grupo experimento formado por ratos que foram tratados com extrato aquoso de aroeira a 10% e um grupo controle tratado com o veÃculo à base de carboximetilcelulose (CMC), ambos sob forma de enema. Cada grupo foi dividido em quatro subgrupos conforme a data da eutanÃsia (3, 7, 14 e 21 dias). Vinte e quatro horas apÃs a induÃÃo da colite os animais foram submetidos ao exame endoscÃpico e em seguida à laparotomia para a realizaÃÃo da secÃÃo total do cÃlon e posterior anastomose cÃlica, tÃrmino-terminal, em plano Ãnico com fio de polipropileno 5-0. Os animais foram avaliados do ponto de vista morfolÃgico (soluÃÃo de continuidade, crosta fibrino-leucocitÃria, edema, exsudato, neoformaÃÃo vascular, neoformaÃÃo conjuntiva e reepitelizaÃÃo), morfomÃtrico (neutrÃfilos, eosinÃfilos, histiÃcitos, linfÃcitos, plasmÃcitos, fibroblastos e vasos) e pressÃo de ruptura (explosÃo) do segmento colÃnico. No estudo histolÃgico corado pelo TricrÃmico de Masson avaliou-se a proliferaÃÃo do colÃgeno. Os segmentos colÃnicos foram retirados para estudos nas respectivas datas da eutanÃsia. Na anÃlise morfolÃgica observou-se uma superioridade do grupo Aroeira sobre o grupo VeÃculo no vigÃsimo primeiro dia. Na avaliaÃÃo morfomÃtrica, nÃo ficou evidenciado nenhuma aÃÃo antiinflamatÃria por parte da aroeira, porÃm ela apresentou resultados superiores ao grupo controle na segunda e terceira fase da cicatrizaÃÃo que correspondem respectivamente a fase de fibroplasia (proliferaÃÃo fibroblÃstica) e maturaÃÃo e remodelagem que à a deposiÃÃo de colÃgeno na matriz cicatricial. O nÃvel pressÃrico foi estatisticamente significante no terceiro dia, sendo o Grupo Aroeira superior ao Grupo VeÃculo. Conclui-se que o extrato aquoso de aroeira-do-sertÃo a 10%, desenvolve atividade cicatrizante na anastomose cÃlica na vigÃncia de colite experimental induzida por Ãcido acÃtico a 10%, em ratos Wistar, atuando na fase dois e trÃs da cicatrizaÃÃo aumentando a fibroplasia e a deposiÃÃo de colÃgeno na matriz cicatricial / The colorectal anastomosis awakens interest for the studies because it presents elevated morbidity and mortality. This occurs mainly, by dehiscence, attributed to several factors, including inflammatory. The aroeira-do-sertÃo (Myracrodruon urundeuva Fr. All.), a plant of the Anacardiaceae family, is known for its antiinflammatory and healing properties, appearing as a alternative therapy. Facing these known qualities, it was decided to verify its action on the colonic anastomosis while under 10% acetic acid induced experimental colitis, in Wistar rats. Were utilized 48 rats,males, with average weight 340g, distributed in two groups of 24. One experiment group formed by rats that were treated with 10% aqueous extract of aroeira-do-sertÃo and one control group treated with carboxymethylcellulose (CMC) based vehicle, both in the enema form. Each group was divided into four subgroups according to the date of euthanasia (days 3, 7, 14 and 21). Twenty-four hours after the inducion of colitis the animals were subjected to endoscopic examination and after that laparotomy for the performance of the total section of the colon and posterior colonic anastomosis, end-to-end, in single plane with 5-0 polypropylene. The animals were evaluated from the morphological (disruption of epithelial basement membranecontinuity, fibrin clot, edema, exudate, vascularity, connective new formation and reepithelization), morphometric (neutrophils, eosinophils, histiocytes, lymphocyte, plasma cells, fibroblasts and vessels) and rupture pression (explosion) of the colonic segment point of view. On the histological study dyed by trichrome stain it was evaluated the collagen proliferation. The colonic segments were removed for studies on the respective dates of euthanasia. On the morphological analysis it was observed a superiority on Aroeira group over Vehicle group on the twenty-first day. On the morphometric evaluation, it was noticed no antiinflammatory action on the part of aroeira, but it presented results superior to the control group on the second and third phases of healing that correspond respectively to the phase of fibroplasia (fibroblastic proliferation) and maturation and remodeling which is collagen deposition on the healing matrix. The pressoric level was statistically significant on the third day, being the Aroeira Group superior to the Vehicle Group. It is concluded that the 10% aqueous extract of aroeira-do-sertÃo, develops healing activity on the colonic anastomosis under 10% acetic acid induced experimental colitis, in Wistar rats, acting on phase two and three of healing increasing the fibroplasias and the collagen deposition on the healing matrix.

Anal acoustic reflectometry (AAR) is a technique that is currently under investigation for the assessment of faecal incontinence. It uses reflected sounds waves to measure cross sectional area at different pressures leading to a profile of the anal canal, and in particular the high pressure zone of the anal sphincters. The cross sectional area from the high pressure zone is then plotted on a graph to give seven characteristic parameters. AAR has been shown to be reproducible and reliable, able to distinguish between continence and incontinence, correlate with the severity of incontinence and able to discriminate between the three patterns of incontinence (urge, passive and mixed). Opening pressure has been shown to be an independent predictor of success with peripheral nerve evaluation, the trial period before sacral nerve stimulation. This thesis aimed to validate AAR against manometry and explore its physiological and clinical potential. A retrospective analysis of 265 patients who had undergone AAR was undertaken in order to develop a surrogate marker for anal canal length. The surrogate marker did find the expected difference between men and women but this was not clinically significant. Furthermore, the surrogate marker was unable to differentiate between incontinence and continence. A technical limitation (Gibbs phenomenon) of AAR was subsequently shown to explain this unexpected result. Prior manometry could possibly interfere with the interpretation of AAR, and therefore a prospective randomised cohort study of 30 patients was conducted to assess two orders of data collection. Reassuringly it does not matter which one of these investigations is undertaken first. In order to test the hypothesis that the greater the challenge to the anal sphincter, the greater the response, the effect of two rates of anal canal stretch was investigated in a prospective randomised cohort study of 50 patients with faecal incontinence. No difference was found between normal or fast rates of AAR. This study has validated a faster method of AAR that can be used alongside manometry in any order. A pudendal nerve block was used to investigate whether AAR assesses primarily internal or external sphincter function in a prospective cohort study of 15 patients using both AAR and manometry. Bilateral pudendal nerve block reduced the function of the external anal sphincter but had no effect on the internal sphincter using both techniques. This study suggests that AAR at rest is predominately an investigation of the internal anal sphincter. A prospective study of 30 patients with faecal incontinence was carried out to establish if AAR can predict the outcome from posterior tibial nerve stimulation. Posterior tibial nerve stimulation improved rectal sensation, manometry squeeze pressures, quality of life, severity of incontinence and was more effective for patients with urge incontinence. A variety of demographic, clinical and physiological measures were unable to predict the success of posterior tibial nerve stimulation. The results presented in this thesis suggest that the full clinical potential of AAR has yet to be realised and it will be necessary to compare it with high resolution anal manometry in the future. Progress in this field would be greatly facilitated by establishing the normal values for this technique and the development of a robust AAR assessment of the external anal sphincter.

Abstract Purpose: This study evaluated the use of hyperspectral imaging for the determination of the resection margin during colorectal resections instead of clinical macroscopic assessment. Methods: The used hyperspectral camera is able to record light spectra from 500 to 1000 nm and provides information about physiologic parameters of the recorded tissue area intraoperatively (e.g., tissue oxygenation and perfusion). We performed an open-label, single-arm, and non-randomized intervention clinical trial to compare clinical assessment and hyperspectral measurement to define the resection margin in 24 patients before and after separation of the marginal artery over 15 min; HSI was performed each minute to assess the parameters mentioned above. Results: The false color images calculated from the hyperspectral data visualized the margin of perfusion in 20 out of 24 patients precisely. In the other four patients, the perfusion difference could be displayed with additional evaluation software. In all cases, there was a deviation between the transection line planed by the surgeon and the border line visualized by HSI (median 1 mm; range - 13 to 13 mm). Tissue perfusion dropped up to 12% within the first 10 mm distal to the border line. Therefore, the resection area was corrected proximally in five cases due to HSI record. The biggest drop in perfusion took place in less than 2 min after devascularization. Conclusion: Determination of the resection margin by HSI provides the surgeon with an objective decision aid for assessment of the best possible perfusion and ideal anastomotic area in colorectal surgery.:Inhaltsverzeichnis Inhaltsverzeichnis................................................................. I 1 Einführung............................................................................. 1 1.1 Anastomoseninsuffizienz...................................................1 1.2 Methodik Hyperspectral Imaging (HSI)............................. 3 1.3 Einsatzbereiche der Hyperspektral-Kamera..................... 5 1.4 Chirurgische Technik........................................................ 6 1.5 Studienplanung................................................................. 7 1.6 Vergleich der HSI-Technik mit weiteren Messmethoden...8 2 Publikation...............................................................................11 3 Zusammenfassung der Arbeit............................................... 21 4 Literaturverzeichnis............................................................... 26 5 Anhang.................................................................................... 30 Darstellung des eigenen Beitrags.........................................34 Eigenständigkeitserklärung...................................................35 Lebenslauf.............................................................................. 36 Danksagung........................................................................... 38

京都大学 / 0048 / 新制・論文博士 / 博士(医学) / 乙第13166号 / 論医博第2153号 / 新制||医||1029(附属図書館) / (主査)教授 一山 智, 教授 松原 和夫, 教授 万代 昌紀 / 学位規則第4条第2項該当 / Doctor of Medical Science / Kyoto University / DFAM

Yes / Medical technologies have the potential to improve quality and efficiency of healthcare. The design of clinical trials should consider participants' perspectives to optimise enrolment, engagement and satisfaction. This study aims to assess patients' perceptions of their involvement in medical device trials, to inform the designs of future medical technology implementation and evaluation. Four focus groups were undertaken with a total of 16 participants who had participated in a study testing hospital inpatient remote monitoring devices. Interviews were audio-recorded, transcribed verbatim and underwent thematic analysis. Four main themes emerged: patients' motivations for participating in medical device research; patients' perceptions of technology in medicine; patients' understanding of trial methodology; and patients' perceptions of the benefits of involvement in medical device trials. The appeal of new technology is a contributing factor to the decision to consent, although concerns remain regarding risks associated with technology in healthcare settings. Perceived benefits of participating in device trials include extra care, social benefits and comradery with other participants seen using the devices, although there is a perceived lack of confidence in using technology amongst older patients. Future device trials should prioritise information sharing with participants both before and after the trial. Verbal and written information alongside practical demonstrations can help to combat a lack of confidence with technology. Randomised trials and those with placebo- or sham-controlled arms should not be considered as barriers to participation. Study results should be disseminated to participants in lay format as soon as possible, subject to participant permission. / The patients in this study were participating in a randomised controlled trial funded by a Health Foundation Innovating for Improvement Award (Grant number: GIFTS 7643 CRM 2674). Candice Downey is in possession of a Doctoral Research Fellowship (DRF-2016-09- 037) supported by the National Institute for Health Research. DGJ received funding support through an NIHR Research Professorship. The research is supported by the NIHR infrastructure at Leeds.

Background: Trauma is a major cause of death and disability. Adverse events, such as prolonged prehospital time, hypoxia, hypotension and/or hyperventilation have been reported to correlate to poor outcome. Adequate cortisol levels are essential for survival after major trauma. In hypotensive critically ill patients, lack of sufficient amount of cortisol can be suspected, and a concept of critical illness related corticosteroid insufficiency has been proposed. Corticosteroid therapy has many adverse effects in critically ill patients and should only be given if life-saving. Correct measurement of serum cortisol levels is important but difficult in critically ill patients with capillary leakage. Estimation of the free and biologically active cortisol is preferable. In serum less than 10% of cortisol is free and biologically active and not possible to measure with routine laboratory methods. Salivary cortisol can be used as a surrogate for free cortisol, but salivary production is reduced in critically ill patients. Liver resection could reduce cortisol levels due to substrate deficiency. Aims: 1. Evaluate the occurrence of early adverse events in patients with traumatic brain injury and relate them to outcome. 2. Assess cortisol levels over time after trauma and correlate to severity of trauma, sedative/analgesic drugs and cardiovascular function. 3. Evaluate if saliva stimulation could be performed without interfering with salivary cortisol levels. 4. Assess cortisol levels over time after liver resection in comparison to other major surgery. Results: There was no significant correlation between prehospital time ³60 minutes, hypoxia (saturation <95%), hypotension (systolic blood pressure <90 mmHg), or hyperventilation (ETCO2 <4.5 kPa) and a poor outcome (Glasgow Outcome Scale 1-3) in patients with traumatic brain injury. Cortisol levels decreased significantly over time after trauma, but there was no correlation between low (<200 nmol/L) serum cortisol levels and severity of trauma. Infusion of sedative/analgesic drugs was the strongest predictor for a low (<200 nmol/L) serum cortisol. The odds ratio for low serum cortisol levels (<200 nmol/L) was 8.0 for patients receiving continuous infusion of sedative/analgesic drugs. There was no significant difference between unstimulated and stimulated salivary cortisol levels (p=0.06) in healthy volunteers. Liver resection was not associated with significantly lower cortisol levels compared to other major surgery. Conclusion: There was no significant correlation between early adverse events and outcome in patients with traumatic brain injury. Cortisol levels decreased significantly over time in trauma patients. Low cortisol levels (<200 nmol/L) were significantly correlated to continuous infusion of sedative/analgesic drugs. Saliva stimulation could be performed without interfering with salivary cortisol levels. Liver resection was not associated with low cortisol levels compared to other major surgery.

Trata-se de um estudo descritivo prospectivo, com abordagem quantitativa, sobre as complicações de estoma e de pele periestoma de estomizados intestinais em seguimento ambulatorial, que teve como objetivos caracterizar o perfil sociodemográfico e clínico desta clientela em um hospital universitário de ensino público; descrever a presença de fatores de risco descritos na literatura científica para esta clientela; e analisar a presença de complicações de estoma e de pele periestoma nesta clientela (CEP/EERP 383.771). Os critérios de inclusão da amostra foram pacientes maiores de 18 anos, independente da raça, classe social e sexo, com estomias intestinais e em seguimento ambulatorial no período da coleta de dados e o critério de exclusão foi paciente com instabilidade clínica. A amostra de conveniência foi composta por 56 estomizados. Utilizou-se instrumento de coleta de dados, contemplando dados sociodemográficos, clínicos e terapêuticos, assim como presença de complicações de estoma e pele periestoma e utilização de equipamentos coletores e adjuvantes. A coleta de dados ocorreu no período de setembro de 2013 a fevereiro de 2014. Foi criado um banco de dados no Excel, mediante dupla digitação, cuja análise estatística descritiva foi realizada pelo Programa SPSS, versão 17.0, com frequência absoluta, relativa e percentual. Os resultados evidenciaram distribuição equitativa em relação ao sexo, média de idade de 56,2 anos, predomínio das neoplasias colorretais 31 (55,4%), de normalidade do índice de massa corporal 47 (83,9%), presença de comorbidades 7 (12,5%), realização de quimioterapia adjuvante 15 (26,8%), cirurgias de grande porte 43 (76,8%) e demarcação pré-operatória 43 (76,8%) e 21 (37,5%) pacientes com complicações de estoma e pele periestoma. Do total de 43 (76,8%) demarcados, 14 (32,6%) apresentaram complicações, enquanto que nos 13 (23,2%) não demarcados, 7 (53,8%) tiveram complicações. Em relação aos equipamentos coletores e adjuvantes 51 (91%) utilizavam bolsa de duas peças, drenável 51 (91%), base flexível 31 (55,4%), cinto 40 (71,4%) e barreira protetora 1 (1,8%). Os fatores de risco para complicações de estoma e de pele periestoma como idade avançada, comorbidade, localização do estoma, não demarcação de estoma e não utilização de barreiras protetoras foi verificada na amostra. Conclui-se que no seguimento ambulatorial desta clientela, há necessidade de avaliação periódica e sistematizada em relação ao autocuidado, indicação dos equipamentos coletores e adjuvantes com adaptação às necessidades de cada paciente, além da identificação dos fatores de risco para prevenção destas complicações / This is a prospective descriptive study with a quantitative approach, on the complications of the stoma and peristomal skin of ostomy intestinal outpatients, we aimed to characterize the sociodemographic and clinical profile of the clientele in a university hospital in public education; describe the presence of risk factors described in the scientific literature for this clientele; and analyze the presence of complications of the stoma and peristomal skin in this clientele (CEP / EERP 383 771). The inclusion criteria for the sample were patients older than 18 years, regardless of race, social class and gender, with intestinal stomas and in outpatients in the period of data collection and the exclusion criteria were patients with clinical instability. The convenience sample consisted of 56 ostomates. Instrument was used for data collection, covering sociodemographic, clinical and therapeutic data, as well as the presence of complications of the stoma and peristomal skin and use of equipment and aids collectors. Data collection occurred from September 2013 to February 2014. A database in Excel, by double entry, whose descriptive statistical analysis was performed using SPSS, version 17.0, with absolute, relative and percentage frequency was created. The results showed equal distribution in relation to sex, average age of 56.2 years, prevalence of colorectal neoplasms 31 (55.4%), normal body mass index 47 (83.9%), presence of comorbidities 7 (12.5%) accomplishment of adjuvant chemotherapy 15 (26.8%), large surgeries 43 (76.8%) and preoperative demarcation 43 (76.8%) and 21 (37.5%) patients with complications of the stoma and peristomal skin. Of 43 (76.8%) demarcated, 14 (32.6%) had complications, whereas in 13 (23.2%) unmarked, 7 (53.8%) had complications. Regarding equipment collectors and adjuvants 51 (91%) used two-piece pouch, drainable 51 (91%), flexible base 31 (55.4%), belt 40 (71.4%) and protective barrier 1 (1, 8%). Risk factors for complications of the stoma and peristomal skin such as age, comorbidity, location of stoma, no demarcation of stoma and non-use of protective barriers was seen in the sample. It is concluded that, for the outpatients, there is need for regular and systematic review in relation to self-care, statement of collectors equipment and aids to adapt to the needs of each patient during follow-up of this clientele, in addition to the identification of risk factors for prevention of these complications

Trata-se de um estudo descritivo prospectivo, com abordagem quantitativa, sobre as complicações de estoma e de pele periestoma de estomizados intestinais em seguimento ambulatorial, que teve como objetivos caracterizar o perfil sociodemográfico e clínico desta clientela em um hospital universitário de ensino público; descrever a presença de fatores de risco descritos na literatura científica para esta clientela; e analisar a presença de complicações de estoma e de pele periestoma nesta clientela (CEP/EERP 383.771). Os critérios de inclusão da amostra foram pacientes maiores de 18 anos, independente da raça, classe social e sexo, com estomias intestinais e em seguimento ambulatorial no período da coleta de dados e o critério de exclusão foi paciente com instabilidade clínica. A amostra de conveniência foi composta por 56 estomizados. Utilizou-se instrumento de coleta de dados, contemplando dados sociodemográficos, clínicos e terapêuticos, assim como presença de complicações de estoma e pele periestoma e utilização de equipamentos coletores e adjuvantes. A coleta de dados ocorreu no período de setembro de 2013 a fevereiro de 2014. Foi criado um banco de dados no Excel, mediante dupla digitação, cuja análise estatística descritiva foi realizada pelo Programa SPSS, versão 17.0, com frequência absoluta, relativa e percentual. Os resultados evidenciaram distribuição equitativa em relação ao sexo, média de idade de 56,2 anos, predomínio das neoplasias colorretais 31 (55,4%), de normalidade do índice de massa corporal 47 (83,9%), presença de comorbidades 7 (12,5%), realização de quimioterapia adjuvante 15 (26,8%), cirurgias de grande porte 43 (76,8%) e demarcação pré-operatória 43 (76,8%) e 21 (37,5%) pacientes com complicações de estoma e pele periestoma. Do total de 43 (76,8%) demarcados, 14 (32,6%) apresentaram complicações, enquanto que nos 13 (23,2%) não demarcados, 7 (53,8%) tiveram complicações. Em relação aos equipamentos coletores e adjuvantes 51 (91%) utilizavam bolsa de duas peças, drenável 51 (91%), base flexível 31 (55,4%), cinto 40 (71,4%) e barreira protetora 1 (1,8%). Os fatores de risco para complicações de estoma e de pele periestoma como idade avançada, comorbidade, localização do estoma, não demarcação de estoma e não utilização de barreiras protetoras foi verificada na amostra. Conclui-se que no seguimento ambulatorial desta clientela, há necessidade de avaliação periódica e sistematizada em relação ao autocuidado, indicação dos equipamentos coletores e adjuvantes com adaptação às necessidades de cada paciente, além da identificação dos fatores de risco para prevenção destas complicações / This is a prospective descriptive study with a quantitative approach, on the complications of the stoma and peristomal skin of ostomy intestinal outpatients, we aimed to characterize the sociodemographic and clinical profile of the clientele in a university hospital in public education; describe the presence of risk factors described in the scientific literature for this clientele; and analyze the presence of complications of the stoma and peristomal skin in this clientele (CEP / EERP 383 771). The inclusion criteria for the sample were patients older than 18 years, regardless of race, social class and gender, with intestinal stomas and in outpatients in the period of data collection and the exclusion criteria were patients with clinical instability. The convenience sample consisted of 56 ostomates. Instrument was used for data collection, covering sociodemographic, clinical and therapeutic data, as well as the presence of complications of the stoma and peristomal skin and use of equipment and aids collectors. Data collection occurred from September 2013 to February 2014. A database in Excel, by double entry, whose descriptive statistical analysis was performed using SPSS, version 17.0, with absolute, relative and percentage frequency was created. The results showed equal distribution in relation to sex, average age of 56.2 years, prevalence of colorectal neoplasms 31 (55.4%), normal body mass index 47 (83.9%), presence of comorbidities 7 (12.5%) accomplishment of adjuvant chemotherapy 15 (26.8%), large surgeries 43 (76.8%) and preoperative demarcation 43 (76.8%) and 21 (37.5%) patients with complications of the stoma and peristomal skin. Of 43 (76.8%) demarcated, 14 (32.6%) had complications, whereas in 13 (23.2%) unmarked, 7 (53.8%) had complications. Regarding equipment collectors and adjuvants 51 (91%) used two-piece pouch, drainable 51 (91%), flexible base 31 (55.4%), belt 40 (71.4%) and protective barrier 1 (1, 8%). Risk factors for complications of the stoma and peristomal skin such as age, comorbidity, location of stoma, no demarcation of stoma and non-use of protective barriers was seen in the sample. It is concluded that, for the outpatients, there is need for regular and systematic review in relation to self-care, statement of collectors equipment and aids to adapt to the needs of each patient during follow-up of this clientele, in addition to the identification of risk factors for prevention of these complications

Background: In light of the opioid epidemic, reducing excess prescription quantities while tailoring to patient need is key. We previously created an opioid prescribing guideline using retrospective institutional data to satisfy the majority of patients’ opioid needs following inpatient colorectal surgery. Objective: This study sought to prospectively validate an institutional prescribing guideline based on previously-defined opioid consumption patterns following inpatient colorectal operations. Methods: We carried out a cohort study comparing opioid prescribing and consumption patterns before (7/18 – 1/19) and after (9/19 – 2/20) adoption of a tiered opioid prescribing guideline for inpatient elective colorectal operations (colectomies, proctectomies, and ostomy reversals) at a single tertiary care medical center. Opioid use was quantified as Equianalgesic 5mg Oxycodone Pills (EOP), and patients were grouped in three tiers based on opioid consumption in the 24-hours prior to discharge: Tier 1 (0 EOP), Tier 2 (0.1-3 EOP), and Tier 3 (>3 EOP). Our guideline recommended maximum prescriptions of 0 EOP for Tier 1, 12 EOP for Tier 2, and 30 EOP for Tier 3. Results: The study included 100 patients before and 101 after guideline adoption. Demographic and operative variables were similar before and after guideline adoption. Guideline adherence was 85%. Overall, there was a 41% reduction in mean prescription quantity and 53% reduction in excess pills per prescription with no change in opioid consumption or refill rates. Conclusion: Adoption of a tiered opioid prescribing guideline significantly reduced opioid prescription quantity with no change in consumption or refill rates. Standardization of discharge prescriptions based on patient consumption in the 24 hours prior to discharge may be an important step towards minimizing excess prescribing.